Nce exclusivity expiring in 20141. All Rights Reserved © IBRSoluTions, Hyderabad, India
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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.
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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
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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
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Bio-Process Technology
Polymer Science
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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
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