Thomson Scientific Introduces a New Quarterly Report Identifying the 'Movers and Shakers' in the U.S. Generic...(is the first step inthe process a compan...),Health

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 messag
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