New Chemical Entity (NCE) products receive five years of market exclusivity after approval in the United States, during which the FDA will not accept or approve ANDA's or 505(b)(2) applications for generic versions; with an exception of ANDA or 505(b)(2) applications can be filed 1 year before NCE exclusivity expires with Paragraph IV certification with respect to one or more Orange Book listed patents. NCE exclusivity expiry determines the pipeline selection of generic products as well 505b(2) products, here is a list of products and their analysis whose NCE exclusivity is expiring in 2014.

1. All Rights Reserved © IBRSoluTions, Hyderabad, India
E-mail: info@ibrsolutions.com
Website: www.ibrsolutions.com
1
E-mail: info@ibrsolutions.com
Website: www.ibrsolutions.com
NCE EXCLUSIVITY EXPIRING IN
2014

2. All Rights Reserved © IBRSoluTions
Bringing a new drug molecule into the market is a very costly affair.
Simultaneously, it is a time consuming and uncertain process that takes
years to complete. As patents covering any pharmaceutical products or
processes are filed long before their product candidates are ready to go to
market, there is often very little, if any, patent protection left on the
product at the time of marketing. Many times, patent protection expires
before a new drug is approved for marketing. So many drug regulatory
bodies provide exclusivity to the innovator for the new chemical entity
(NCE) to recoup their considerable investment in the drug development
and approval process. Exclusivity provides the holder of an approved new
drug application limited protection from new competition in the
marketplace for the innovation represented by its approved drug product.
New Drug Product Exclusivity is provided by USFDA under The Federal
Food, Drug, and Cosmetic Act under section 505(c)(3)(E) and
505(j)(5)(F). This limited protection precludes approval of certain
505(b)(2) applications or certain abbreviated new drug applications
(ANDAs) for prescribed periods of time. New Chemical Entity (NCE) by
the FDA, the product receives five years of market exclusivity after
approval in the United States, regardless of the patent situation. During this
time the FDA will also not accept or approve ANDA's or 505(b)(2)
applications for generic versions. With an exception to the above
provision, an ANDA or 505(b)(2) applications can be filed 1 year before
NCE exclusivity expires with Paragraph IV certification with respect to
one or more Orange Book patents.
A leading professional innovation
and business research solutions
providing company.
Services We Provide:
 Intellectual Property
Research Solutions
 Business & Market
Research Solutions
 Innovation Research
Solutions
 Knowledge Research
Solutions
 Insight Pharma
For more information about
various services we provide,
please mail to us at
info@ibrsolutions.com or log
on to www.ibrsolutions.com.

3. All Rights Reserved © IBRSoluTions
With the advantage of 180 days exclusivity for generic company to be
first to file an ANDA, many pharmaceutical companies act proactively
well before the expiry of NCE exclusivity. The given below is the list of
NCE exclusivity expiring in 2014.
Product Name NCE Exclusivity
Milnacipran hydrochloride Jan 14, 2014
Febuxostat Feb 13, 2014
Everolimus Mar 30, 2014
Artemether; Lumefantrine Apr 07, 2014
Benzyl alcohol Apr 09, 2014
Pancrelipase (Amylase; Lipase; Protease) Apr 30, 2014
Tolvaptan May 19, 2014
Besifloxacin hydrochloride May 28, 2014
Dronedarone hydrochloride Jul 01, 2014
Prasugrel hydrochloride Jul 10, 2014
Saxagliptin hydrochloride Jul 31, 2014
Metformin; Saxagliptin Jul 31, 2014
Pitavastatin calcium Aug 03, 2014
Asenapine maleate Aug 13, 2014
Vigabatrin Aug 21, 2014
Pancrelipase (Amylase; Lipase; Protease) Aug 27, 2014
Bepotastine besilate Sep 08, 2014
Telavancin hydrochloride Sep 11, 2014
Pralatrexate Sep 24, 2014
Pazopanib hydrochloride Oct 19, 2014
Romidepsin Nov 05, 2014
Capsaicin Nov 16, 2014
Domains Expertise:
 Pharmaceuticals
 Bio-pharmaceuticals
 Biotechnology
 Neutraceutical
 Veterinary Products/ Pet
care
 Cosmetics and Wellness
Product
 API (Active Pharmaceutical
Ingredients)
 Medical Devices
 Life sciences
 Nanotechnology
 Biochemistry
 Immunotechnology
 Food and Food Technology
 Consumers Goods
 Chemistry and Chemical
 Bio-Process Technology
 Polymer Science
 Agrochemicals

4. All Rights Reserved © IBRSoluTions
The drug products approved in 2009 are across various therapeutic areas.
Below presentation shows therapeutic areas in which drug products are
approved in 2009.
The average number of patent listed in the Orange Book against the
products approved in 2009 i.e. NCE exclusivity expiring in 2014 is three.
But the number of patent listed against each product ranges from zero to
eleven. The presentation below is patents listed in the Orange Book against
each product approved in 2009.
0
1
2
3
4
5 Therapeutic Area
0
2
4
6
8
10
12 No. of Orange Book Listed patents
OurDomains
Expertise:
 Pharmaceuticals
 Bio-pharmaceuticals
 Biotechnology
 Neutraceutical
 Veterinary Products/ Pet
care
 Cosmetics and Wellness
Product
 API (Active Pharmaceutical
Ingredients)
 Medical Devices
 Life sciences
 Nanotechnology
 Biochemistry
 Immunotechnology
 Food and Food Technology
 Consumers Goods
 Chemistry and Chemical
 Bio-Process Technology
 Polymer Science
Our Clients:
 Corporate House
 Investment and IP
Brokerage Firms
 Investors
 Venture Capitalists and
Consulting Firms
 Law Firms
 Patent Attorneys
 IP Licensing and
Management Companies
 Academic Institutions
 Individual Inventors
 Startups Companies
 Innovation & Technology
Driven Companies
 R&D Stakeholders
 IP Traders and Litigation
Experts
 Legal and In-House Patent
Counsels
 Technology Licensing Firm

5. All Rights Reserved © IBRSoluTions
Out of the all approved drug products in 2009 in US, more half of the
drug products are administered through oral route and also more than
half products are oral tablet.
64%9%
4%
14%
9%
Route of Administration
ORAL Ophthalmic Sublingual Injection Topical
Type of Dosage Form
ORAL TABLET
TOPICAL LOTION
DELAYED RELEASE ORAL
CAPSULE
OPHTHALMIC
SUSPENSION/DROPS
SUBLINGUAL TABLET
ORAL SOLUTION
OPHTHALMIC
SOLUTION/DROPS
IV (INFUSION) POWDER
INTRAVENOUS SOLUTION
TOPICAL PATCH
Engagement Models:
 On Demand Model
 Dedicated Team Model
 Dedicated Hours Model
 Offshore Development
Contact Us:
17-37, Sri Ram Nagar,
Alwal, Secunderabad-500010,
Andhra Pradesh, India
Phone: +91 9177350890
E-mail: info@ibrsolutions.com
Website: www.ibrsolutions.com