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All Rights Reserved © IBRSoluTions, Hyderabad, India
E-mail: info@ibrsolutions.com
Website: www.ibrsolutions.com
1
E-mail:...
All Rights Reserved © IBRSoluTions
Bringing a new drug molecule into the market is a very costly affair.
Simultaneously, i...
All Rights Reserved © IBRSoluTions
With the advantage of 180 days exclusivity for generic company to be
first to file an A...
All Rights Reserved © IBRSoluTions
The drug products approved in 2009 are across various therapeutic areas.
Below presenta...
All Rights Reserved © IBRSoluTions
Out of the all approved drug products in 2009 in US, more half of the
drug products are...
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Nce exclusivity expiring in 2014

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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.

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Nce exclusivity expiring in 2014

  1. 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. 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. 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. 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. 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

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