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The World Generic Market Report 2010
Published on January 2010

                                                                                                            Report Summary

Consolidation continues as US companies expand
Corporate consolidation continues to change the operating landscape, most notably the move by US company Mylan in its acquisition
of Merck Generics and recent purchase of Arrow. These developments mark a more international shift in the US market and reflects
growing price pressure in the domestic market.


EU gets tough on anti-competitive practice
Anxieties about anti-competitive practices in many European markets has seen the EU authorities take action, with a number of
company offices raided as allegations are investigated. As recently as October 2009 it has been reported that many companies,
including Sandoz, Teva and Ranbaxy have been the subject of such action.


Opportunities over the next 3 years look very promising
The generic sector is set for a boost as patents on a number of high-profile blockbuster products expire. Lipitor, Zyprexa, Actos,
Avandia, Cymbalta and Plavix are just some of the leading brands likely to be challenged in the next few years.


Key company, market and product information
To understand the generic market, Espicom, publisher of the respected twice-monthly business publication World Generic Markets,
has published The World Generic Market Report 2010. Packed with facts, figures, analysis and statistics, the new 2-volume 680-page
edition provides the most thorough analysis available on generic markets, products and companies, and the issues they face.




                                                                                                            Table of Content

Volume I: Global Overview and Company Profiles
FOREWORD
Current Issues in the USA
   Authorised generics
   FDA issues direct final rule regarding listing of authorised generics
   Moves in Congress
   Ban on reverse payments a step closer; authorised generics come under scrutiny
   Shared exclusivity
Industry consolidation
Biosimilars
   In the USA
   In Europe
   Elsewhere
   Market acceptance
   Who will the developers be'
Access to Generic Drugs in the Developing World: WTO Agreement



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   2003 Agreement
   TRIPS patent ruling on least-developed countries, 2002
   Canada
   Apotex uses the law
   Canadian Senate begins amendment hearings
   European Union
   European Parliament pushes for greater access to generic drugs
   European patent rules streamlined
   EGA claims WTO compulsory licence system is unworkable
   Pressure groups criticise EU stance on access to medicines
   Generic drug shipments seized in the EU
   PEPFAR
   FDA marks 100th product approved under PEPFAR
Current Issues in the European Union
   European Union Regulatory Reforms Take Effect, November 2005
   Product definition
   Data exclusivity
   European Commission regulations for paediatric medicines introduced in 2007
   Enlargement of the European Union
   Parallel Trade in the enlarged EU
   EC releases final report into pharmaceutical sector
   EC carries out surprise inspections at pharmaceutical firms
Major Generic Manufacturers
Actavis
   Executive Summary
   Background
   Products
   Manufacturing sites
   Financials
   Major developments
   Actavis launches in Ireland
   Actavis to restructure manufacturing operations in Bulgaria
   Actavis opens R&D laboratories in Florida
   Congressional Committee turns attention to Actavis recall
   Mergers, acquisitions and agreements
   Actavis enters co-development relationship with Bioluz
   LPA to distribute Actavis' generic products in Algeria
   ASKA Pharmaceutical and Actavis enter alliance and joint venture in Japan
   Actavis expands presence in India
   Actavis formally launches in France
   Actavis signs distribution agreement with J&M Pharma
   Actavis divests Polish products to Glenmark
   Litigation
   Endo and Penwest settle oxymorphone litigation with Actavis
   Actavis challenges lisdexamphetamine NCE exclusivity
   Warner Chilcott and Mayne Pharma add Actavis to doxycycline litigation
   Justice Department seeks permanent injunction against Actavis
Apotex
   Introduction
   Background


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   Products
   ApoTriavir
   Second and last Apotex CAMR shipment leaves for Rwanda
   Apotex to develop biosimilar G-CSF with IBP
   Plavix (clopidogrel)
   sanofi-aventis and Bristol-Myers Squibb win US clopidogrel court action
   sanofi-aventis wins Canadian clopidogrel patent case against Apotex
   Apotex overturns Australian clopidogrel patent
   Financials
   Cangene
   Biopharmaceutical operations
   Major developments
   Apotex receives FDA warning letter
   Mergers, acquisitions and agreements
   Apotex signs fentanyl agreement with Hisamitsu
   Cangene acquires US commercialisation rights for HepaGam B
   BMP Sunstone launches Ferriprox in China
   Litigation
   Allergan sees brimonidine patent infringement victory
   Unigene's Fortical patent valid
   AstraZeneca gains budesonide preliminary injunction against Apotex
   Pronova receives omega-3-acid Paragraph IV letters
   Dorzolamide and timolol
   Apotex gains UK damages in perindopril case
   US Federal Court affirms omeprazole ruling
   Sanofi-aventis sues Apotex over docetaxel
   Pfizer enters settlement agreement with Apotex over atorvastatin
   Apotex loses ketorolac appeal
Aspen Pharmacare
   Introduction
   Background
   Products
   HIV/AIDS drugs
   Tenofovir-based ARVs
   Efavirenz
   Abacavir
   South African government ARV tender
   PEPFAR
   Other Antiretrovirals
   Financials
   Segment data
   South African Business
   International Business
   Major developments
   Mergers, acquisitions and agreements
   GlaxoSmithKline
   Relationship between Aspen and Frankel Chemicals questioned
   Aspen to distribute Acrux' Ellavie in South Africa
   Aspen and Matrix end joint venture
   Aspen and Strides revise Latin America terms


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   GSK, Aspen, and Strides Arcolab announce tie-up
Barr Pharmaceuticals
   Introduction
   Background
   Products
   Duramed's BLA for Ad Type 4 and 7 vaccines accepted by FDA
   Financials
   Major developments
   Mergers, acquisitions and agreements
   Teva acquires Barr
   BioReliance to supply bulk virus for the manufacture of adenovirus vaccine
   Barr successfully acquires Pliva
   Litigation
   Cephalon settles fentanyl lawsuit with Barr
   Watson and Barr settle oxybutynin lawsuit
   Sepracor settles levalbuterol litigation against Teva / Barr
   Shire files lawsuit against Barr for infringement of Fosrenol patents
   Warner Chilcott settles Femcon, Loestrin patent challenges; initiates doxycycline action
   Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr over generic Amrix
   sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US patent litigations
   Barr initiates oxybutynin transdermal system patent challenge
   Barr confirms patent challenge of Opana ER
   Court of Appeals upholds 1997 Cipro settlement
   Court favours Barr and Mylan in galantamine case
   Barr initiates clozapine patent challenge
   Barr enters agreement to settle Aggrenox patent challenge
   Texas AG pursues generic manufacturers over false prices
   Barr challenges cinacalcet patents
   Barr launches levocetirizine challenge
   Barr confirms fentanyl challenge
Cipla
   Introduction
   Background
   Cipla planning Rs 9,500 million expansion
   Products
   Financials
   Major developments
   HIV/AIDS
   Thai government in talks with Cipla over antiretroviral ingredients
   AHF and Cipla quarrel over AIDS drugs prices
   Clinton Foundation and UNITAID announce agreements to reduce ARV prices
   Mergers, acquisitions and agreements
   Meda
   Akorn
Dr Reddy's Laboratories
   Introduction
   Background
   Dr Reddy's launches US Specialty Business
   Dr Reddy's realigns Global Generics geography portfolio
   New acquisitions, FY2008-09, betapharm


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   Products
   Dr Reddy's files fondaparinux ANDA for Alchemia
   Financials
   Segment Data
   Pharmaceutical Services and Active Ingredients (PSAI)
   Global Generics
   India
   North America
   Russia and the CIS
   Europe
   Rest of the World
   Major developments
   Dr Reddy's, Stada and Teva report successes in AOK tenders in the German market
   Mergers, acquisitions & agreements
   GlaxoSmithKline enters strategic alliance with Dr Reddy's
   Dr Reddy's makes dermatology product advances
   TMH/Dr Reddy's sign agreement to create self-injectable product
   Dr Reddy's and Albemarle sign ibuprofen API deal
   Aquapharm signs new agreement and extends R&D licence with Dr Reddy's
   Litigation
   AMRI files patent infringement lawsuits against Dr Reddy's and Sandoz
   Dr Reddy's gains favourable omeprazole ruling
   Dr Reddy's enter desloratadine litigation settlement
   Teva and Dr Reddy's settle carvedilol suit
   AstraZeneca sues Dr Reddy's over generic zafirlukast
   US court affirms that Eisai's Aciphex patent is valid and enforceable
Egis
   Introduction
   Background
   Products
   Financials
   International sales
   Russia and the CIS
   Central and Eastern Europe
   Western Europe
   Major developments
   Mergers, acquisitions and agreements
   Egis and Gedeon Richter divest Medimpex
   Serdix
Hospira
   Introduction
   Background
   Project Fuel
   Manufacturing facilities
   Products
   Product Development
   Financials
   Results by region
   Americas
   EMEA


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   APAC
   Hospira: results by region, fiscal years ended 31st December in US$ millions
   Major Developments
   Mergers, acquisitions and agreements
   Hospira and Celltrion enter biosimilars agreement
   Hospira gains filgrastim rights and manufacturing facility from Pliva
   ICU secures purchase of Hospira's Critical Care product line
   Hospira signs new contracts for IV solutions and equipment
   HGS to manufacture biopharmaceuticals for Hospira
   Altea and Hospira enter deal for transdermal product
   Litigation
   Orion and Hospira file dexmedetomidine lawsuit against Sandoz
   Hospira, Teva gain oxaliplatin summary judgements
   Doxycycline
KRKA
   Introduction
   Background
   Key strategic objectives and strategies to 2012
   Krka Group business objectives for 2009
   Products
   Marketing authorisations
   Prescription pharmaceuticals
   Financials
   Results by Regions
   Slovenia
   South-Eastern Europe
   Eastern Europe
   Central Europe
   Western Europe and Overseas Market
   Product and Service Groups
   Major developments
   Mergers, acquisitions and agreements
   Krka acquires Alternova AT
   Krka purchases shares in Zhejiang and Anhui
   Facilities
   Slovenia
   Krka opens new chemical development laboratories
Lannett
   Introduction
   Background
   Products
   Financial
   Major developments
   Lannett subsidiary completes FDA inspection
   FDA acts to halt marketing of unapproved prescription narcotics, then backtracks
   Lannett to enter pain management market
   Litigation
   Lannett files lawsuit against KV
Mylan
   Introduction


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   Background
   Mylan to retain Dey subsidiary
   Products
   ANDA Approvals
   FDA accepts Mylan ANDA for glatiramer
   Merck Generics subsidiary ANDA Approvals
   Financials
   Segment Data
   Major developments
   Mylan sets up shop in Canada
   Matrix Laboratories
   Mylan downsizes Puerto Rico facility
   Mergers, acquisitions and agreements
   Mylan, Matrix and the Clinton Foundation agree new lower prices for HIV/AIDS drugs
   Matrix selected by Clinton Initiative as primary supplier for antiretrovirals
   Mylan enters collaboration with Biocon
   Mylan signs OC agreement with Famy Care
   Litigation
   Teva files glatiramer lawsuit against Mylan
   Mylan and Pfizer settle voriconazole litigation
   Mylan and others enter into settlements resolving False Claims Act violation claims
   Dey settles Utah pricing litigation
   Mylan files lawsuit against Pittsburgh Post-Gazette
   Daiichi Sankyo claims victory in patent litigation against Mylan
   Warner Chilcott files further doxycycline lawsuit against Mylan
   Mylan announces desloratadine settlement
   Galderma files lawsuit against Mylan
   Sepracor files eszopiclone patent infringement lawsuits
   OSI files lawsuits against Teva and Mylan
   Shire files lanthanum patent infringement lawsuit against Mylan
   Daiichi Sankyo files patent infringement actions in Japan over generic levofloxacin
   Dey settles Mississippi pricing litigation
   Takeda wins attorney's fee in patent case against Mylan and Alphapharm
   Warner Chilcott/Mayne file lawsuits for infringement of Doryx patent
   Mylan/Novartis enter agreement to settle Femara patent challenge
   Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr over generic Amrix
   Court favours Barr and Mylan in galantamine case
   Daiichi Sankyo sues Matrix for Azor patent infringement
Par Pharmaceuticals
   Introduction
   Background
   Par resizes generic unit
   Products
   Financial
   Segment Data
   Major Developments
   Senators introduce bill to stop 'pay-off' agreements, as FTC files complaint in court
   Mergers, acquisitions and agreements
   Alvogen acquires R&D capabilities from Par
   MDRNA sells contract manufacturing facilities to Par


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   Strativa gains nasal spray rights
   MonoSolRx licenses thin film formulation of ondansetron to Strativa
   Litigation
   Par sees success in tramadol ER litigation
   Pronova BioPharma files omega-3-acid lawsuits against Apotex and Par
   Par and Reliant settle propafenone litigation
   Par Pharmaceutical receives paroxetine litigation setback
   Santarus makes gains against Par in Markman hearing
   Texas AG pursues generic manufacturers over false prices
Perrigo
   Introduction
   Background
   Products
   Financials
   Segment Sales
   Consumer Healthcare
   Rx Pharmaceuticals
   API
   Other
   Major developments
   Perrigo to expand operations in Michigan
   Mergers, acquisitions and agreements
   Perrigo purchases clindamycin and benzoyl ANDA from KV Pharmaceutical
   Perrigo enters licensing and authorised generic agreements with Medimetriks
   Perrigo acquires Unico Holdings
   Perrigo acquires Mexico's Laboratorios Diba
   Perrigo acquires exclusive US rights to generic levocetirizine
   Perrigo purchases JB Laboratories
   NeutraHealth purchases Perrigo UK
   Litigation
   Clindamycin and benzoyl litigation dismissed
   Stiefel files suit in US following Perrigo's ANDA filing for generic Men's Rogaine
   Perrigo partner Synthon files levocetirizine ANDA
   Perrigo partner files clindamycin ANDA, initiating patent challenge
   Perrigo settle desloratadine patent litigation
   Perrigo dismissed from miconazole patent litigation
   Perrigo files ANDA for generic Vanos; Medicis files suit
Pliva
   Introduction
   Background
   Pliva delists from London Stock Exchange
   Products
   Biosimilars
   Financials
   Geographical Data
   Major developments
   Mergers, acquisitions and agreements
   Hospira gains filgrastim rights and manufacturing facility from Pliva
   Pliva divests Spanish operations
   Pliva divests Italian operations to Biomedica


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   Pliva to acquire ORCApharm
   Barr successfully acquires Pliva
   Litigation
   The Medicines Company files bivalirudin lawsuits against Teva, Pliva and APP
   California court rules branded firms can be liable for generics
   Barr confirms patent challenge regarding UCB's Xyzal
Ranbaxy
   Introduction
   Background
   Ranbaxy acquired by Daiichi Sankyo
   Products
   Ranbaxy begins Phase III study of combination antimalarial
   Antiretrovirals
   Financials
   Results by Geography
   North America
   European Union
   UK
   Germany
   France
   Romania
   India
   Asia Pacific
   Russia & Ukraine
   Africa
   Latin America
   Results by Therapy
   Major developments
   Ranbaxy relocates European headquarters
   Daiichi Sankyo to commercialise products in Mexico through Ranbaxy subsidiary
   South African Competition Commission places conditions on Aspen / GlaxoSmithKline agreement224
   Ranbaxy gains Japanese GMP approval for non-sterile plant
   Ranbaxy's Paonta Sahib plant gains overseas GMP approvals
   Ranbaxy initiates Phase I studies for respiratory inflammation; gains milestone from GSK
   FDA issues Warning Letters, blocks imports from two Ranbaxy facilities
   Congressional Committee expands Ranbaxy probe to include PEPFAR programme
   Daiichi acquires Ranbaxy
   Mergers, acquisitions and agreements
   Ranbaxy acquires dermatology products from Ochoa
   Ranbaxy to market Gliadel for gliomas in India
   Cipher / Ranbaxy enter agreement for CIP-Isoptretinoin acne treatment
   Litigation
   Danish Court upholds two atorvastatin patents
   Ranbaxy, Goldshield win SFO cases
   Ranbaxy comes under fire from US Justice Department
   Pfizer and Ranbaxy settle majority of worldwide atorvastatin litigations
ratiopharm
   Introduction
   Background
   BioGeneriX


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   Merckle Biotec
   Merckle
   PulmoTec
   ratiopharm direct
   Products
   Financials
   Major developments
   ratiopharm to be sold
   ratiopharm to cut jobs'
   Mergers, acquisitions and agreements
   Neose sells assets to Novo Nordisk and BioGeneriX as first step in liquidation
   Litigation
   ratiopharm Canada wins amlodipine patent challenge
   Ontario government takes enforcement action against generic firms
   sanofi-aventis to appeal German generic clopidogrel marketing authorisations
Gedeon Richter
   Introduction
   Background
   Products
   Financials
   Markets
   Hungary
   International sales
   CIS
   EU
   USA and Other Countries
   Major developments
   Mergers, acquisitions and agreements
   KV enters women's health agreement with Gedeon Richter
   Gedeon Richter enters marketing and distribution agreement with HRA Pharma
   Gedeon Richter licenses DSM/Crucell's PER.C6 cell line
   Richter to build biopharmaceutical plant in Debrecen
   Litigation
   Gedeon Richter and Merck settle alendronate lawsuit
Sandoz
   Introduction
   Background
   Products
   Sandoz' top-ten products worldwide
   Financials
   Major developments
   Sandoz opens extension to Aeropharm facility
   WHO issues Notice of Concern to Sandoz South Africa
   FDA sends Sandoz warning letter over metoprolol
   Mergers, Acquisitions and Agreements
   Sandoz acquires Ebewe Pharma
   Litigation
   Shire/Sandoz settle all pending litigation concerning Adderall XR
   AMRI files patent infringement lawsuits against Dr Reddy's and Sandoz
   US Court of Appeals affirms summary judgement decision in Seroquel patent litigation


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   Orion and Hospira file dexmedetomidine lawsuit against Sandoz
   Ontario government takes enforcement action against generic firms
   Teva to file lawsuit against Momenta/Sandoz over generic glatiramer
   Summary judgement granted for Seroquel patent litigation
sanofi-aventis
   Introduction
   Winthrop Pharmaceuticals
   France
   Germany
   Portugal
   United Kingdom
   Zentiva
   Products
   Financials
   Sales by segment
   Pharmaceutical Sales by Region
   Major developments
   sanofi-aventis withdraws applications to extend use of Taxotere and Docetaxel Winthrop in BC ..274
   Mergers, acquisitions and agreements
   Prasco enters authorised generics sales and distribution agreement with Winthrop
   Nycomed acquires Zentiva branded generics
   sanofi-aventis acquires Mexican generic producer
   Zentiva acquired by sanofi-aventis
   Zentiva completes purchase of Eczacibasi's generic pharmaceuticals business
Sawai Pharmaceutical
   Introduction
   Background
   Products
   New government supply rules, 2006
   Heparin calcium, flutazolam, biperiden hydrochloride
   Synthetic penicillin
   Financials
   Major developments
   Mergers, acquisitions and agreements
   Towa, Sawai and Nichi-iko sign agreement for stable supply of generic products
   Medisa Shinyaku
   Nihon Schering's Mobara factory
   Litigation
   Shionogi files cefcapene lawsuit against Sawai
   Daiichi Sankyo files patent infringement lawsuits over levofloxacin generics
Stada Arzneimittel
   Introduction
   Background
   Products
   Biosimilars
   Refusal of marketing approval confirmed by CHMP for Stada's fentanyl patches
   Financial
   Segment Data
   Geographic Segment Data
   Germany


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   Russia
   Serbia
   Italy
   Belgium
   United Kingdom
   France, Spain, Netherlands and Ireland
   Major developments
   Stada reports success in AOK tenders in the German market
   Stada opens Vietnam plant with EU approval
   Mergers, acquisitions and agreements
   Eisai China signs licence agreement for Alpha-Lipon 300 Stada
   Litigation
   Stada says olanzapine judgement will cost the firm
Teva Pharmaceutical Industries
   Introduction
   Background
   Products
   Antares/Teva file sNDA for needlefree injector for HGH product
   Financials
   Pharmaceutical Sales
   North America
   Europe
   International
   Innovative Products
   Biogenerics
   Major developments
   Teva submits biologic licence application with FDA
   Teva reports success in AOK tenders in the German market
   Mergers, acquisitions and agreements
   Codexis expands collaboration with Teva
   Abbott and Fournier enter fenofibrate licence agreement with Teva
   Vical grants Teva sales and marketing rights for Allovectin-7 in Israel
   Antares receives payment from Teva for commercial development of Vibex product
   Optimata to collaborate with Teva on development of solid tumour cancer drugs
   EC approves Teva and Lonza joint venture
   Dynamix enters drug-discovery/development alliance with Teva
   Jexys enters R&D collaboration with Teva
   Indevus/Teva enter deal to develop pagoclone for stuttering
   Teva and Kowa form strategic partnership to concentrate on Japanese generic market
   Teva and Proteologics extend anticancer collaboration
   Consortium acquires Teva's controlling stake in IVAX Diagnostics
   Teva to market CEL-SCI's Multikine in Israel and Turkey
   Teva signs agreement for Capricorn's Korkoat technology platform
   Teva acquires Barr
   Litigation
   Shire and Teva settle mixed amphetamines authorised generic litigation
   Armodafinil
   Fentanyl buccal
   Glatiramer
   Bivalirudin


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   Quetiapine
   Solifenacin
   Raloxifene
   Montelukast
   Oxaliplatin
   Drospirenone / ethinyloestradiol (Yasmin)
   Ethinyloestradiol / norgestimate (Ortho Tri-Cyclen Lo)
   Vardenafil
   GlaxoSmithKline loses Irish Seretide patent challenge
   Pantoprazole
   Emtricitabine
   Risedronate
   Omega-3 acid
   Cubist files patent lawsuit against Teva
   OSI files lawsuits against Teva and Mylan
   Sepracor settles levalbuterol litigation against Teva / Barr
   Teva gains budesonide approval, flurry of activity results
   Teva loses lansoprazole litigation
   California court rules branded firms can be liable for generics
   sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US patent litigations
   Appellate court reverses generic risperidone exclusivity decision
   Teva and Dr Reddy's settle carvedilol suit
   Appeals Court favours Eisai in rabeprazole judgement
Towa Pharmaceutical
   Introduction
   Background
   Products
   Financials
   Major developments
   Mergers and Agreements
   Towa, Sawai and Nichi-iko reach supply agreement
   Litigation
   Daiichi Sankyo files patent infringement lawsuits over levofloxacin generics
Watson Pharmaceuticals
   Introduction
   Background
   Arrow Group
   Andrx
   Products
   Generics
   Brand Products
   Distribution
   Financials
   Segment Results
   Major developments
   Mergers, acquisitions and agreements
   Watson acquires Arrow Group
   Watson and GeneraMedix reach sodium ferric gluconate licence agreement
   Watson acquires products related to Teva's acquisition of Barr
   Mylan buys out Watson's Somerset Pharma stake


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   Litigation
   Watson and Barr settle oxybutynin lawsuit
   Watson initiates trospium chloride challenge
   Watson files guaifenesin pseudoephedrine ANDA
   Swiss arbitration affirms Watson's supply and distribution agreement with sanofi-aventis
   Watson and Elan settle naproxen lawsuit
   FTC files complaint against Solvay, Watson and Par
   Warner Chilcott settles Femcon, Loestrin patent challenges
   Watson loses naproxen patent dispute
   Texas AG pursues generic manufacturers over false prices
Wockhardt
   Introduction
   Background
   Products
   Financials
   Major developments
   Wockhardt to restructure its R&D business
   Mergers, acquisitions and agreements
   Wockhardt sells off its German business
   Abbott to acquire Wockhardt's nutrition businesses
   Wockhardt signs in-licensing agreement with DSM Nutritional
   Sinclair Pharma
   Litigation
   Orion and Wockhardt settle entacapone-based products litigation
Zydus Cadila
   Introduction
   Background
   Products
   Zydus to expand range of generics in Japan
   Zydus collaborates with WHO to develop MAb cocktail for rabies
   Financials
   Financial highlights
   Domestic formulations
   API and intermediates
   US market
   Europe
   Latin America
   Japan
   Asia Pacific, Africa, Middle East and CIS regions
   Major Developments
   Mergers, acquisitions and agreements
   Zydus and Lilly collaborate on CV drug discovery/development
   Zydus acquires Etna Biotech
   Zydus acquires majority stake in Simayla Pharmaceuticals
Volume II: National Markets
Overview
   Population
   GDP per capita
   Health Expenditure
   Total Pharmaceutical Expenditure


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   Generic Pharmaceutical Expenditure
   Generic Market Projections
Australia
   Introduction
   Pharmaceutical Market
   PBS prescription data
   Generic Market
   Summary Outlook
   Regulation
   International harmonisation
   Intellectual Property
   US Free Trade Agreement, Generic Amendments
   Parliament passes patent springboarding Bill
   Pricing & Reimbursement
   Rise in Co-payment rates, 2005
   Therapeutic Group Premiums
   US Free Trade Agreement
   Government announces new pricing measures for newly listed drugs
   Government announces further PBS reforms, 2006
   Manufacturing
   Alphapharm
   Apotex (formerly GenRx)
   Arrow Pharmaceuticals Pty
   Ascent Pharmahealth Pty Ltd (formerly Genepharm)
   Aspen Australia
   Generic Health/Bellwether Pharma
   Mayne Pharma (Hospira)
   Ranbaxy Australia
   Sandoz Pty Ltd
   Sigma Pharmaceuticals (Australia) Pty Ltd
   Winthrop Pharmaceuticals
Brazil
   Introduction
   Pharmaceutical Market
   Generic Market
   Size
   Bestsellers Losing Patents
   Generic Drug Seizure
   Outlook & Projections
   Production of Oral Generic Contraceptives & Hormones
   Unsustainable Reliance on Original HIV/AIDS Medicines
   Patent rejection of tenofovir
   National production of efavirenz
   Price negotiation of lopinavir+ritonavir
   Intellectual Property
   Upcoming Patent Expiries
   Pricing & reimbursement
   Price Rises From 1st April 2008
   Manufacturing
   ALANAC


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   Pró-Genéricos
   Aché
   Americano de Farmacoterapia (FARMASA)
   Arrow (Erowlabs)
   Brainfarma
   Cimed
   Cristália
   EMS Sigma Pharma
   Eurofarma
   Hipolabor
   LAFEPE
   Medley
   Neo Química
   Prati, Donaduzzi
   Teuto
   União Química
Canada
   Introduction
   Pharmaceutical Market
   Generic Market
   Size
   Outlook & Projections
   Intellectual Property
   New rules come into effect, October 2006
   CGPA issues legal challenge
   Canadian government proposes new rules to confirm 2006 evergreening changes
   Canada's Access to Medicine Regime
   Parliament revisits the legislation
   Pricing & reimbursement
   PMPRB issues report on non-patented prescription drug prices
   Price increases between 2004 and 2005
   Provincial Formularies
   The Quebec 15-year rule
   Ontario Bill 102
   Drug Insurance Programmes
   Manufacturing
   Apotex
   Cobalt Pharma
   Mylan Pharmaceuticals ULC (formely Genpharm)
   Novopharm
   Orbus Pharma
   Pharmascience
   Ranbaxy
   ratiopharm
   Sandoz
France
   Introduction
   Pharmaceutical Market
   Generic Market
   Size


The World Generic Market Report 2010                                                                  Page 16/21
Find Industry reports, Company profiles
ReportLinker                                                                and Market Statistics


   Outlook & Projections
   Outcomes of the New Reference Pricing System
   Increasing Prescribing of Generics
   Intellectual Property
   Supplementary Protection Certificates
   Pricing & Reimbursement
   Pricing
   Pricing of Reimbursable Medicines in the Retail Pharmacy Market
   Price Revisions
   Pricing Activity
   Pharmacy Margins
   Reference Pricing (TFR)
   Pricing of Hospital Medicines
   Reimbursement
   Manufacturing
   Local Manufacturers & Suppliers
   Arrow Génériques
   Biogaran
   EG-Labo (Stada)
   Mylan (formerly Merck Génériques)
   Ranbaxy
   ratiopharm
   Sandoz
   Teva
   Winthrop
   Wockhardt
   Zydus France
Germany
   Introduction
   Pharmaceutical Market
   GKV Drug Expenditure
   Generic Market
   Size
   Outlook & Projections
   Intellectual Property
   Pricing & Reimbursement
   Pricing
   Reimbursement
   AOK Negotiates Pharmaceutical Supplier Contracts for 2009/11
   Generic Substitution Policies
   Compulsory Manufacturer Rebates
   AVWG, 2006
   Manufacturing
   Accedo Arzneimittel GmbH
   Actavis Deutschland
   betapharm
   CT-Arzneimittel
   Heumann Pharma Generics/Torrent Pharmaceuticals
   Hexal
   Hospira Deutschland GmbH


The World Generic Market Report 2010                                                                   Page 17/21
Find Industry reports, Company profiles
ReportLinker                                              and Market Statistics


   Mylan Dura (formerly Merck Dura)
   Neuraxpharm
   ratiopharm
   Ribosepharm
   Sandoz
   Stada Arzneimittel
   Winthrop Arzneimittel
Italy
   Introduction
   Pharmaceutical Market
   Retail Pharmacy Sales
   Generic Market
   Size
   Outlook & Projections
   Intellectual Property
   National Supplementary Protection Certificate
   Pricing & reimbursement
   Pricing
   Reimbursement
   Manufacturing
   ASSOGENERICI
   Local Manufacturers
   Angenerico
   DOC Generici
   Eurogenerici (Stada Arzneimittel)
   Hexan
   Merck Generics Italia (Mylan)
   Pliva Pharma
   Ranbaxy
   ratiopharm Italia
   Sandoz
   Teva Pharma Italia
Japan
   Introduction
   Pharmaceutical Market
   Generic Market
   Size
   Generic substitution plans
   Outlook & Projections
   Regulations
   Generic regulation, 2005
   Intellectual Property
   Data Exclusivity
   Exclusion of Use
   Patent term extensions
   Pricing & Reimbursement
   Yakkasa
   Price reductions
   Generic drug pricing
   Manufacturing


The World Generic Market Report 2010                                                 Page 18/21
Find Industry reports, Company profiles
ReportLinker                                      and Market Statistics


   MHLW Stable Supply Requirements, 2006
   Overseas players
   Netherlands
   Introduction
   Pharmaceutical Market
   Generic Market
   Size
   Outlook & Projections
   Intellectual Property
   Pricing & Reimbursement
   Pricing
   Medicines Covenant (2004-2007)
   Reimbursement
   Manufacturing
   Actavis
   Centrafarm BV/Stada Arzneimittel
   Disphar International BV
   Katwijk Farma BV




The World Generic Market Report 2010                                         Page 19/21
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ReportLinker                                                                          and Market Statistics


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The World Generic Market Report 2010

  • 1. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! The World Generic Market Report 2010 Published on January 2010 Report Summary Consolidation continues as US companies expand Corporate consolidation continues to change the operating landscape, most notably the move by US company Mylan in its acquisition of Merck Generics and recent purchase of Arrow. These developments mark a more international shift in the US market and reflects growing price pressure in the domestic market. EU gets tough on anti-competitive practice Anxieties about anti-competitive practices in many European markets has seen the EU authorities take action, with a number of company offices raided as allegations are investigated. As recently as October 2009 it has been reported that many companies, including Sandoz, Teva and Ranbaxy have been the subject of such action. Opportunities over the next 3 years look very promising The generic sector is set for a boost as patents on a number of high-profile blockbuster products expire. Lipitor, Zyprexa, Actos, Avandia, Cymbalta and Plavix are just some of the leading brands likely to be challenged in the next few years. Key company, market and product information To understand the generic market, Espicom, publisher of the respected twice-monthly business publication World Generic Markets, has published The World Generic Market Report 2010. Packed with facts, figures, analysis and statistics, the new 2-volume 680-page edition provides the most thorough analysis available on generic markets, products and companies, and the issues they face. Table of Content Volume I: Global Overview and Company Profiles FOREWORD Current Issues in the USA Authorised generics FDA issues direct final rule regarding listing of authorised generics Moves in Congress Ban on reverse payments a step closer; authorised generics come under scrutiny Shared exclusivity Industry consolidation Biosimilars In the USA In Europe Elsewhere Market acceptance Who will the developers be' Access to Generic Drugs in the Developing World: WTO Agreement The World Generic Market Report 2010 Page 1/21
  • 2. Find Industry reports, Company profiles ReportLinker and Market Statistics 2003 Agreement TRIPS patent ruling on least-developed countries, 2002 Canada Apotex uses the law Canadian Senate begins amendment hearings European Union European Parliament pushes for greater access to generic drugs European patent rules streamlined EGA claims WTO compulsory licence system is unworkable Pressure groups criticise EU stance on access to medicines Generic drug shipments seized in the EU PEPFAR FDA marks 100th product approved under PEPFAR Current Issues in the European Union European Union Regulatory Reforms Take Effect, November 2005 Product definition Data exclusivity European Commission regulations for paediatric medicines introduced in 2007 Enlargement of the European Union Parallel Trade in the enlarged EU EC releases final report into pharmaceutical sector EC carries out surprise inspections at pharmaceutical firms Major Generic Manufacturers Actavis Executive Summary Background Products Manufacturing sites Financials Major developments Actavis launches in Ireland Actavis to restructure manufacturing operations in Bulgaria Actavis opens R&D laboratories in Florida Congressional Committee turns attention to Actavis recall Mergers, acquisitions and agreements Actavis enters co-development relationship with Bioluz LPA to distribute Actavis' generic products in Algeria ASKA Pharmaceutical and Actavis enter alliance and joint venture in Japan Actavis expands presence in India Actavis formally launches in France Actavis signs distribution agreement with J&M Pharma Actavis divests Polish products to Glenmark Litigation Endo and Penwest settle oxymorphone litigation with Actavis Actavis challenges lisdexamphetamine NCE exclusivity Warner Chilcott and Mayne Pharma add Actavis to doxycycline litigation Justice Department seeks permanent injunction against Actavis Apotex Introduction Background The World Generic Market Report 2010 Page 2/21
  • 3. Find Industry reports, Company profiles ReportLinker and Market Statistics Products ApoTriavir Second and last Apotex CAMR shipment leaves for Rwanda Apotex to develop biosimilar G-CSF with IBP Plavix (clopidogrel) sanofi-aventis and Bristol-Myers Squibb win US clopidogrel court action sanofi-aventis wins Canadian clopidogrel patent case against Apotex Apotex overturns Australian clopidogrel patent Financials Cangene Biopharmaceutical operations Major developments Apotex receives FDA warning letter Mergers, acquisitions and agreements Apotex signs fentanyl agreement with Hisamitsu Cangene acquires US commercialisation rights for HepaGam B BMP Sunstone launches Ferriprox in China Litigation Allergan sees brimonidine patent infringement victory Unigene's Fortical patent valid AstraZeneca gains budesonide preliminary injunction against Apotex Pronova receives omega-3-acid Paragraph IV letters Dorzolamide and timolol Apotex gains UK damages in perindopril case US Federal Court affirms omeprazole ruling Sanofi-aventis sues Apotex over docetaxel Pfizer enters settlement agreement with Apotex over atorvastatin Apotex loses ketorolac appeal Aspen Pharmacare Introduction Background Products HIV/AIDS drugs Tenofovir-based ARVs Efavirenz Abacavir South African government ARV tender PEPFAR Other Antiretrovirals Financials Segment data South African Business International Business Major developments Mergers, acquisitions and agreements GlaxoSmithKline Relationship between Aspen and Frankel Chemicals questioned Aspen to distribute Acrux' Ellavie in South Africa Aspen and Matrix end joint venture Aspen and Strides revise Latin America terms The World Generic Market Report 2010 Page 3/21
  • 4. Find Industry reports, Company profiles ReportLinker and Market Statistics GSK, Aspen, and Strides Arcolab announce tie-up Barr Pharmaceuticals Introduction Background Products Duramed's BLA for Ad Type 4 and 7 vaccines accepted by FDA Financials Major developments Mergers, acquisitions and agreements Teva acquires Barr BioReliance to supply bulk virus for the manufacture of adenovirus vaccine Barr successfully acquires Pliva Litigation Cephalon settles fentanyl lawsuit with Barr Watson and Barr settle oxybutynin lawsuit Sepracor settles levalbuterol litigation against Teva / Barr Shire files lawsuit against Barr for infringement of Fosrenol patents Warner Chilcott settles Femcon, Loestrin patent challenges; initiates doxycycline action Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr over generic Amrix sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US patent litigations Barr initiates oxybutynin transdermal system patent challenge Barr confirms patent challenge of Opana ER Court of Appeals upholds 1997 Cipro settlement Court favours Barr and Mylan in galantamine case Barr initiates clozapine patent challenge Barr enters agreement to settle Aggrenox patent challenge Texas AG pursues generic manufacturers over false prices Barr challenges cinacalcet patents Barr launches levocetirizine challenge Barr confirms fentanyl challenge Cipla Introduction Background Cipla planning Rs 9,500 million expansion Products Financials Major developments HIV/AIDS Thai government in talks with Cipla over antiretroviral ingredients AHF and Cipla quarrel over AIDS drugs prices Clinton Foundation and UNITAID announce agreements to reduce ARV prices Mergers, acquisitions and agreements Meda Akorn Dr Reddy's Laboratories Introduction Background Dr Reddy's launches US Specialty Business Dr Reddy's realigns Global Generics geography portfolio New acquisitions, FY2008-09, betapharm The World Generic Market Report 2010 Page 4/21
  • 5. Find Industry reports, Company profiles ReportLinker and Market Statistics Products Dr Reddy's files fondaparinux ANDA for Alchemia Financials Segment Data Pharmaceutical Services and Active Ingredients (PSAI) Global Generics India North America Russia and the CIS Europe Rest of the World Major developments Dr Reddy's, Stada and Teva report successes in AOK tenders in the German market Mergers, acquisitions & agreements GlaxoSmithKline enters strategic alliance with Dr Reddy's Dr Reddy's makes dermatology product advances TMH/Dr Reddy's sign agreement to create self-injectable product Dr Reddy's and Albemarle sign ibuprofen API deal Aquapharm signs new agreement and extends R&D licence with Dr Reddy's Litigation AMRI files patent infringement lawsuits against Dr Reddy's and Sandoz Dr Reddy's gains favourable omeprazole ruling Dr Reddy's enter desloratadine litigation settlement Teva and Dr Reddy's settle carvedilol suit AstraZeneca sues Dr Reddy's over generic zafirlukast US court affirms that Eisai's Aciphex patent is valid and enforceable Egis Introduction Background Products Financials International sales Russia and the CIS Central and Eastern Europe Western Europe Major developments Mergers, acquisitions and agreements Egis and Gedeon Richter divest Medimpex Serdix Hospira Introduction Background Project Fuel Manufacturing facilities Products Product Development Financials Results by region Americas EMEA The World Generic Market Report 2010 Page 5/21
  • 6. Find Industry reports, Company profiles ReportLinker and Market Statistics APAC Hospira: results by region, fiscal years ended 31st December in US$ millions Major Developments Mergers, acquisitions and agreements Hospira and Celltrion enter biosimilars agreement Hospira gains filgrastim rights and manufacturing facility from Pliva ICU secures purchase of Hospira's Critical Care product line Hospira signs new contracts for IV solutions and equipment HGS to manufacture biopharmaceuticals for Hospira Altea and Hospira enter deal for transdermal product Litigation Orion and Hospira file dexmedetomidine lawsuit against Sandoz Hospira, Teva gain oxaliplatin summary judgements Doxycycline KRKA Introduction Background Key strategic objectives and strategies to 2012 Krka Group business objectives for 2009 Products Marketing authorisations Prescription pharmaceuticals Financials Results by Regions Slovenia South-Eastern Europe Eastern Europe Central Europe Western Europe and Overseas Market Product and Service Groups Major developments Mergers, acquisitions and agreements Krka acquires Alternova AT Krka purchases shares in Zhejiang and Anhui Facilities Slovenia Krka opens new chemical development laboratories Lannett Introduction Background Products Financial Major developments Lannett subsidiary completes FDA inspection FDA acts to halt marketing of unapproved prescription narcotics, then backtracks Lannett to enter pain management market Litigation Lannett files lawsuit against KV Mylan Introduction The World Generic Market Report 2010 Page 6/21
  • 7. Find Industry reports, Company profiles ReportLinker and Market Statistics Background Mylan to retain Dey subsidiary Products ANDA Approvals FDA accepts Mylan ANDA for glatiramer Merck Generics subsidiary ANDA Approvals Financials Segment Data Major developments Mylan sets up shop in Canada Matrix Laboratories Mylan downsizes Puerto Rico facility Mergers, acquisitions and agreements Mylan, Matrix and the Clinton Foundation agree new lower prices for HIV/AIDS drugs Matrix selected by Clinton Initiative as primary supplier for antiretrovirals Mylan enters collaboration with Biocon Mylan signs OC agreement with Famy Care Litigation Teva files glatiramer lawsuit against Mylan Mylan and Pfizer settle voriconazole litigation Mylan and others enter into settlements resolving False Claims Act violation claims Dey settles Utah pricing litigation Mylan files lawsuit against Pittsburgh Post-Gazette Daiichi Sankyo claims victory in patent litigation against Mylan Warner Chilcott files further doxycycline lawsuit against Mylan Mylan announces desloratadine settlement Galderma files lawsuit against Mylan Sepracor files eszopiclone patent infringement lawsuits OSI files lawsuits against Teva and Mylan Shire files lanthanum patent infringement lawsuit against Mylan Daiichi Sankyo files patent infringement actions in Japan over generic levofloxacin Dey settles Mississippi pricing litigation Takeda wins attorney's fee in patent case against Mylan and Alphapharm Warner Chilcott/Mayne file lawsuits for infringement of Doryx patent Mylan/Novartis enter agreement to settle Femara patent challenge Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr over generic Amrix Court favours Barr and Mylan in galantamine case Daiichi Sankyo sues Matrix for Azor patent infringement Par Pharmaceuticals Introduction Background Par resizes generic unit Products Financial Segment Data Major Developments Senators introduce bill to stop 'pay-off' agreements, as FTC files complaint in court Mergers, acquisitions and agreements Alvogen acquires R&D capabilities from Par MDRNA sells contract manufacturing facilities to Par The World Generic Market Report 2010 Page 7/21
  • 8. Find Industry reports, Company profiles ReportLinker and Market Statistics Strativa gains nasal spray rights MonoSolRx licenses thin film formulation of ondansetron to Strativa Litigation Par sees success in tramadol ER litigation Pronova BioPharma files omega-3-acid lawsuits against Apotex and Par Par and Reliant settle propafenone litigation Par Pharmaceutical receives paroxetine litigation setback Santarus makes gains against Par in Markman hearing Texas AG pursues generic manufacturers over false prices Perrigo Introduction Background Products Financials Segment Sales Consumer Healthcare Rx Pharmaceuticals API Other Major developments Perrigo to expand operations in Michigan Mergers, acquisitions and agreements Perrigo purchases clindamycin and benzoyl ANDA from KV Pharmaceutical Perrigo enters licensing and authorised generic agreements with Medimetriks Perrigo acquires Unico Holdings Perrigo acquires Mexico's Laboratorios Diba Perrigo acquires exclusive US rights to generic levocetirizine Perrigo purchases JB Laboratories NeutraHealth purchases Perrigo UK Litigation Clindamycin and benzoyl litigation dismissed Stiefel files suit in US following Perrigo's ANDA filing for generic Men's Rogaine Perrigo partner Synthon files levocetirizine ANDA Perrigo partner files clindamycin ANDA, initiating patent challenge Perrigo settle desloratadine patent litigation Perrigo dismissed from miconazole patent litigation Perrigo files ANDA for generic Vanos; Medicis files suit Pliva Introduction Background Pliva delists from London Stock Exchange Products Biosimilars Financials Geographical Data Major developments Mergers, acquisitions and agreements Hospira gains filgrastim rights and manufacturing facility from Pliva Pliva divests Spanish operations Pliva divests Italian operations to Biomedica The World Generic Market Report 2010 Page 8/21
  • 9. Find Industry reports, Company profiles ReportLinker and Market Statistics Pliva to acquire ORCApharm Barr successfully acquires Pliva Litigation The Medicines Company files bivalirudin lawsuits against Teva, Pliva and APP California court rules branded firms can be liable for generics Barr confirms patent challenge regarding UCB's Xyzal Ranbaxy Introduction Background Ranbaxy acquired by Daiichi Sankyo Products Ranbaxy begins Phase III study of combination antimalarial Antiretrovirals Financials Results by Geography North America European Union UK Germany France Romania India Asia Pacific Russia & Ukraine Africa Latin America Results by Therapy Major developments Ranbaxy relocates European headquarters Daiichi Sankyo to commercialise products in Mexico through Ranbaxy subsidiary South African Competition Commission places conditions on Aspen / GlaxoSmithKline agreement224 Ranbaxy gains Japanese GMP approval for non-sterile plant Ranbaxy's Paonta Sahib plant gains overseas GMP approvals Ranbaxy initiates Phase I studies for respiratory inflammation; gains milestone from GSK FDA issues Warning Letters, blocks imports from two Ranbaxy facilities Congressional Committee expands Ranbaxy probe to include PEPFAR programme Daiichi acquires Ranbaxy Mergers, acquisitions and agreements Ranbaxy acquires dermatology products from Ochoa Ranbaxy to market Gliadel for gliomas in India Cipher / Ranbaxy enter agreement for CIP-Isoptretinoin acne treatment Litigation Danish Court upholds two atorvastatin patents Ranbaxy, Goldshield win SFO cases Ranbaxy comes under fire from US Justice Department Pfizer and Ranbaxy settle majority of worldwide atorvastatin litigations ratiopharm Introduction Background BioGeneriX The World Generic Market Report 2010 Page 9/21
  • 10. Find Industry reports, Company profiles ReportLinker and Market Statistics Merckle Biotec Merckle PulmoTec ratiopharm direct Products Financials Major developments ratiopharm to be sold ratiopharm to cut jobs' Mergers, acquisitions and agreements Neose sells assets to Novo Nordisk and BioGeneriX as first step in liquidation Litigation ratiopharm Canada wins amlodipine patent challenge Ontario government takes enforcement action against generic firms sanofi-aventis to appeal German generic clopidogrel marketing authorisations Gedeon Richter Introduction Background Products Financials Markets Hungary International sales CIS EU USA and Other Countries Major developments Mergers, acquisitions and agreements KV enters women's health agreement with Gedeon Richter Gedeon Richter enters marketing and distribution agreement with HRA Pharma Gedeon Richter licenses DSM/Crucell's PER.C6 cell line Richter to build biopharmaceutical plant in Debrecen Litigation Gedeon Richter and Merck settle alendronate lawsuit Sandoz Introduction Background Products Sandoz' top-ten products worldwide Financials Major developments Sandoz opens extension to Aeropharm facility WHO issues Notice of Concern to Sandoz South Africa FDA sends Sandoz warning letter over metoprolol Mergers, Acquisitions and Agreements Sandoz acquires Ebewe Pharma Litigation Shire/Sandoz settle all pending litigation concerning Adderall XR AMRI files patent infringement lawsuits against Dr Reddy's and Sandoz US Court of Appeals affirms summary judgement decision in Seroquel patent litigation The World Generic Market Report 2010 Page 10/21
  • 11. Find Industry reports, Company profiles ReportLinker and Market Statistics Orion and Hospira file dexmedetomidine lawsuit against Sandoz Ontario government takes enforcement action against generic firms Teva to file lawsuit against Momenta/Sandoz over generic glatiramer Summary judgement granted for Seroquel patent litigation sanofi-aventis Introduction Winthrop Pharmaceuticals France Germany Portugal United Kingdom Zentiva Products Financials Sales by segment Pharmaceutical Sales by Region Major developments sanofi-aventis withdraws applications to extend use of Taxotere and Docetaxel Winthrop in BC ..274 Mergers, acquisitions and agreements Prasco enters authorised generics sales and distribution agreement with Winthrop Nycomed acquires Zentiva branded generics sanofi-aventis acquires Mexican generic producer Zentiva acquired by sanofi-aventis Zentiva completes purchase of Eczacibasi's generic pharmaceuticals business Sawai Pharmaceutical Introduction Background Products New government supply rules, 2006 Heparin calcium, flutazolam, biperiden hydrochloride Synthetic penicillin Financials Major developments Mergers, acquisitions and agreements Towa, Sawai and Nichi-iko sign agreement for stable supply of generic products Medisa Shinyaku Nihon Schering's Mobara factory Litigation Shionogi files cefcapene lawsuit against Sawai Daiichi Sankyo files patent infringement lawsuits over levofloxacin generics Stada Arzneimittel Introduction Background Products Biosimilars Refusal of marketing approval confirmed by CHMP for Stada's fentanyl patches Financial Segment Data Geographic Segment Data Germany The World Generic Market Report 2010 Page 11/21
  • 12. Find Industry reports, Company profiles ReportLinker and Market Statistics Russia Serbia Italy Belgium United Kingdom France, Spain, Netherlands and Ireland Major developments Stada reports success in AOK tenders in the German market Stada opens Vietnam plant with EU approval Mergers, acquisitions and agreements Eisai China signs licence agreement for Alpha-Lipon 300 Stada Litigation Stada says olanzapine judgement will cost the firm Teva Pharmaceutical Industries Introduction Background Products Antares/Teva file sNDA for needlefree injector for HGH product Financials Pharmaceutical Sales North America Europe International Innovative Products Biogenerics Major developments Teva submits biologic licence application with FDA Teva reports success in AOK tenders in the German market Mergers, acquisitions and agreements Codexis expands collaboration with Teva Abbott and Fournier enter fenofibrate licence agreement with Teva Vical grants Teva sales and marketing rights for Allovectin-7 in Israel Antares receives payment from Teva for commercial development of Vibex product Optimata to collaborate with Teva on development of solid tumour cancer drugs EC approves Teva and Lonza joint venture Dynamix enters drug-discovery/development alliance with Teva Jexys enters R&D collaboration with Teva Indevus/Teva enter deal to develop pagoclone for stuttering Teva and Kowa form strategic partnership to concentrate on Japanese generic market Teva and Proteologics extend anticancer collaboration Consortium acquires Teva's controlling stake in IVAX Diagnostics Teva to market CEL-SCI's Multikine in Israel and Turkey Teva signs agreement for Capricorn's Korkoat technology platform Teva acquires Barr Litigation Shire and Teva settle mixed amphetamines authorised generic litigation Armodafinil Fentanyl buccal Glatiramer Bivalirudin The World Generic Market Report 2010 Page 12/21
  • 13. Find Industry reports, Company profiles ReportLinker and Market Statistics Quetiapine Solifenacin Raloxifene Montelukast Oxaliplatin Drospirenone / ethinyloestradiol (Yasmin) Ethinyloestradiol / norgestimate (Ortho Tri-Cyclen Lo) Vardenafil GlaxoSmithKline loses Irish Seretide patent challenge Pantoprazole Emtricitabine Risedronate Omega-3 acid Cubist files patent lawsuit against Teva OSI files lawsuits against Teva and Mylan Sepracor settles levalbuterol litigation against Teva / Barr Teva gains budesonide approval, flurry of activity results Teva loses lansoprazole litigation California court rules branded firms can be liable for generics sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US patent litigations Appellate court reverses generic risperidone exclusivity decision Teva and Dr Reddy's settle carvedilol suit Appeals Court favours Eisai in rabeprazole judgement Towa Pharmaceutical Introduction Background Products Financials Major developments Mergers and Agreements Towa, Sawai and Nichi-iko reach supply agreement Litigation Daiichi Sankyo files patent infringement lawsuits over levofloxacin generics Watson Pharmaceuticals Introduction Background Arrow Group Andrx Products Generics Brand Products Distribution Financials Segment Results Major developments Mergers, acquisitions and agreements Watson acquires Arrow Group Watson and GeneraMedix reach sodium ferric gluconate licence agreement Watson acquires products related to Teva's acquisition of Barr Mylan buys out Watson's Somerset Pharma stake The World Generic Market Report 2010 Page 13/21
  • 14. Find Industry reports, Company profiles ReportLinker and Market Statistics Litigation Watson and Barr settle oxybutynin lawsuit Watson initiates trospium chloride challenge Watson files guaifenesin pseudoephedrine ANDA Swiss arbitration affirms Watson's supply and distribution agreement with sanofi-aventis Watson and Elan settle naproxen lawsuit FTC files complaint against Solvay, Watson and Par Warner Chilcott settles Femcon, Loestrin patent challenges Watson loses naproxen patent dispute Texas AG pursues generic manufacturers over false prices Wockhardt Introduction Background Products Financials Major developments Wockhardt to restructure its R&D business Mergers, acquisitions and agreements Wockhardt sells off its German business Abbott to acquire Wockhardt's nutrition businesses Wockhardt signs in-licensing agreement with DSM Nutritional Sinclair Pharma Litigation Orion and Wockhardt settle entacapone-based products litigation Zydus Cadila Introduction Background Products Zydus to expand range of generics in Japan Zydus collaborates with WHO to develop MAb cocktail for rabies Financials Financial highlights Domestic formulations API and intermediates US market Europe Latin America Japan Asia Pacific, Africa, Middle East and CIS regions Major Developments Mergers, acquisitions and agreements Zydus and Lilly collaborate on CV drug discovery/development Zydus acquires Etna Biotech Zydus acquires majority stake in Simayla Pharmaceuticals Volume II: National Markets Overview Population GDP per capita Health Expenditure Total Pharmaceutical Expenditure The World Generic Market Report 2010 Page 14/21
  • 15. Find Industry reports, Company profiles ReportLinker and Market Statistics Generic Pharmaceutical Expenditure Generic Market Projections Australia Introduction Pharmaceutical Market PBS prescription data Generic Market Summary Outlook Regulation International harmonisation Intellectual Property US Free Trade Agreement, Generic Amendments Parliament passes patent springboarding Bill Pricing & Reimbursement Rise in Co-payment rates, 2005 Therapeutic Group Premiums US Free Trade Agreement Government announces new pricing measures for newly listed drugs Government announces further PBS reforms, 2006 Manufacturing Alphapharm Apotex (formerly GenRx) Arrow Pharmaceuticals Pty Ascent Pharmahealth Pty Ltd (formerly Genepharm) Aspen Australia Generic Health/Bellwether Pharma Mayne Pharma (Hospira) Ranbaxy Australia Sandoz Pty Ltd Sigma Pharmaceuticals (Australia) Pty Ltd Winthrop Pharmaceuticals Brazil Introduction Pharmaceutical Market Generic Market Size Bestsellers Losing Patents Generic Drug Seizure Outlook & Projections Production of Oral Generic Contraceptives & Hormones Unsustainable Reliance on Original HIV/AIDS Medicines Patent rejection of tenofovir National production of efavirenz Price negotiation of lopinavir+ritonavir Intellectual Property Upcoming Patent Expiries Pricing & reimbursement Price Rises From 1st April 2008 Manufacturing ALANAC The World Generic Market Report 2010 Page 15/21
  • 16. Find Industry reports, Company profiles ReportLinker and Market Statistics Pró-Genéricos Aché Americano de Farmacoterapia (FARMASA) Arrow (Erowlabs) Brainfarma Cimed Cristália EMS Sigma Pharma Eurofarma Hipolabor LAFEPE Medley Neo Química Prati, Donaduzzi Teuto União Química Canada Introduction Pharmaceutical Market Generic Market Size Outlook & Projections Intellectual Property New rules come into effect, October 2006 CGPA issues legal challenge Canadian government proposes new rules to confirm 2006 evergreening changes Canada's Access to Medicine Regime Parliament revisits the legislation Pricing & reimbursement PMPRB issues report on non-patented prescription drug prices Price increases between 2004 and 2005 Provincial Formularies The Quebec 15-year rule Ontario Bill 102 Drug Insurance Programmes Manufacturing Apotex Cobalt Pharma Mylan Pharmaceuticals ULC (formely Genpharm) Novopharm Orbus Pharma Pharmascience Ranbaxy ratiopharm Sandoz France Introduction Pharmaceutical Market Generic Market Size The World Generic Market Report 2010 Page 16/21
  • 17. Find Industry reports, Company profiles ReportLinker and Market Statistics Outlook & Projections Outcomes of the New Reference Pricing System Increasing Prescribing of Generics Intellectual Property Supplementary Protection Certificates Pricing & Reimbursement Pricing Pricing of Reimbursable Medicines in the Retail Pharmacy Market Price Revisions Pricing Activity Pharmacy Margins Reference Pricing (TFR) Pricing of Hospital Medicines Reimbursement Manufacturing Local Manufacturers & Suppliers Arrow Génériques Biogaran EG-Labo (Stada) Mylan (formerly Merck Génériques) Ranbaxy ratiopharm Sandoz Teva Winthrop Wockhardt Zydus France Germany Introduction Pharmaceutical Market GKV Drug Expenditure Generic Market Size Outlook & Projections Intellectual Property Pricing & Reimbursement Pricing Reimbursement AOK Negotiates Pharmaceutical Supplier Contracts for 2009/11 Generic Substitution Policies Compulsory Manufacturer Rebates AVWG, 2006 Manufacturing Accedo Arzneimittel GmbH Actavis Deutschland betapharm CT-Arzneimittel Heumann Pharma Generics/Torrent Pharmaceuticals Hexal Hospira Deutschland GmbH The World Generic Market Report 2010 Page 17/21
  • 18. Find Industry reports, Company profiles ReportLinker and Market Statistics Mylan Dura (formerly Merck Dura) Neuraxpharm ratiopharm Ribosepharm Sandoz Stada Arzneimittel Winthrop Arzneimittel Italy Introduction Pharmaceutical Market Retail Pharmacy Sales Generic Market Size Outlook & Projections Intellectual Property National Supplementary Protection Certificate Pricing & reimbursement Pricing Reimbursement Manufacturing ASSOGENERICI Local Manufacturers Angenerico DOC Generici Eurogenerici (Stada Arzneimittel) Hexan Merck Generics Italia (Mylan) Pliva Pharma Ranbaxy ratiopharm Italia Sandoz Teva Pharma Italia Japan Introduction Pharmaceutical Market Generic Market Size Generic substitution plans Outlook & Projections Regulations Generic regulation, 2005 Intellectual Property Data Exclusivity Exclusion of Use Patent term extensions Pricing & Reimbursement Yakkasa Price reductions Generic drug pricing Manufacturing The World Generic Market Report 2010 Page 18/21
  • 19. Find Industry reports, Company profiles ReportLinker and Market Statistics MHLW Stable Supply Requirements, 2006 Overseas players Netherlands Introduction Pharmaceutical Market Generic Market Size Outlook & Projections Intellectual Property Pricing & Reimbursement Pricing Medicines Covenant (2004-2007) Reimbursement Manufacturing Actavis Centrafarm BV/Stada Arzneimittel Disphar International BV Katwijk Farma BV The World Generic Market Report 2010 Page 19/21
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