Report Draws On Strategic Intelligence and Competitive Analysis Information From Newport Horizon Global(TM)
PHILADELPHIA and LONDON, Jan. 9 -- Thomson Scientific, part of The Thomson Corporation (NYSE: TOC; TSX: TOC) and leading provider of information solutions to the worldwide research and business communities, has released the first issue of Movers and Shakers.
This newest report in the Pharma Matters series analyzes the U.S. generics market from July to September 2007, profiles some of the companies breaking into the market, and highlights molecule patents currently being challenged.
Movers and Shakers reviews the U.S. generics market using strategic intelligence and competitive analysis information drawn from Thomson Scientific's Newport Horizon Global, the critical product targeting and global business development system from the industry authority on the global generics market, in order to assess one of the world's most important pharmaceutical markets.
"Because of the dynamic nature of the generics market in the U.S., the common perception is that the market is relatively easy to break into," said Kate Kuhrt, director, Generics and API Intelligence, Thomson Scientific. "However, our research has shown that there is huge competition between the incumbents and new companies vying for a slice of the market, and clearly there will be winners and losers. Ours is the first quarterly report to identify the real 'movers and shakers' within the generics market."
The first quarterly report covers the period of July to September 2007, and highlights the key indicators of the state of play of the industry. These are:
Abbreviated New Drug Applications (ANDA): An ANDA is the first step in the process a company needs to follow in order to release a generic drug in the U.S. and is submitted to the FDA to prove that the generic version is equivalent to the brand name drug (reference listed drug).
Paragraph IV challenges: A generic company may obtain FDA approval before patent expiry if it certifies its product does not infringe the listed patents or the patents are invalid (paragraph IV certification). In addition, the first company to file an ANDA with paragraph IV certification is awarded a 180-day period of exclusivity for the ensuing generic product, giving the filer an important competitive advantage. Bioequivalent generic versions of drugs that are not protected by patents can be produced and marketed in the U.S. by any company, subject to FDA approval.
Who Are the Movers and Shakers This Quarter?
Molecules recently exposed to paragraph IV challenges: Big Pharma companies such as sanofi-aventis, Eli Lilly, Hoffmann-La Roche and AstraZeneca all saw challenges in the period from July to September on molecules they have patented.
Companies taking their first steps into the US generics industry: The report highlights companies that were felt to be of significant interest. This quarter, the report focuses on Dabur India Ltd, who launched a Paragraph IV challenge on the drug oxaliplatin, Zhejiang Huahai Pharmaceutical Group Co Ltd, a Chinese company that has received tentative approval for nevirapine 200mg tablets under the President's Emergency Plan for Aids Relief (PEPAR) program, and GeneraMedix Pharmaceuticals Inc., an American company based in New Jersey that has received FDA approval for a selection of new products.
"The global stakes involved in the US generics market become evident when you see that the top country filing ANDAs in the US is India, and the company recorded as having the most Paragraph IV patent challenges is Teva, an Israeli Pharma company," added Kuhrt. "Clearly, the message is that American companies cannot presume that they will have a home advantage in this market."
About This Quarterly Report:
Data for this report was compiled and analyzed using Newport Horizon Global(R) a critical product targeting and global business development system from Thomson Scientific. Created specifically for generic pharmaceutical companies and strategic API manufacturers, it allows them to identify and evaluate product opportunities worldwide, ensuring they will be the first to find the generic product and niche opportunity, first to make the deal, and first to get to market.
For a copy of the full report with analysis, visit:
(To view the following url, please copy and paste it into a new browser.) scientific.thomson.com/thomsonpharma/media/pdfs/tpqr/m-a-s-jul- sep07.pdf
About The Thomson Corporation
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Thomson Scientific is a business of The Thomson Corporation. Its information solutions assist professionals at every stage of research and development-from discovery to analysis to product development and distribution. Thomson Scientific information solutions can be found at scientific.thomson.com.
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