Consolidation continues as US companies expandCorporate 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 practiceAnxieties 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 promisingThe 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.
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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
The World Generic Market Report 2010 Page 1/21
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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
The World Generic Market Report 2010 Page 2/21
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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
The World Generic Market Report 2010 Page 3/21
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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
The World Generic Market Report 2010 Page 4/21
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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
The World Generic Market Report 2010 Page 5/21
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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
The World Generic Market Report 2010 Page 6/21
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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
The World Generic Market Report 2010 Page 7/21
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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
The World Generic Market Report 2010 Page 8/21
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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
The World Generic Market Report 2010 Page 9/21
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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
The World Generic Market Report 2010 Page 10/21
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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
The World Generic Market Report 2010 Page 11/21
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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
The World Generic Market Report 2010 Page 12/21
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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
The World Generic Market Report 2010 Page 13/21
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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
The World Generic Market Report 2010 Page 14/21
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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
The World Generic Market Report 2010 Page 15/21
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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
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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
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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
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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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The World Generic Market Report 2010
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