Saturday, June 03, 2006

USFDA files appeal with U.S. Court of Appeals

United States Food & Drug Administration (USFDA) has appealed against the decision of U.S. District Court for the District of Columbia which ruled against the FDA’s decision of denying Ranbaxy and Ivax’s Citizen Petitions concerning exclusivity issue. On May 24, 2006 USFDA filed a motion with U.S. Court of Appeals seeking expedited review concerning Ivax and Ranbaxy’s 180-day exclusivity issue and also proposed a schedule whereby the appeal will be fully briefed over the summer, with arguments to be heard at the Court’s earliest convenience thereafter. Teva has agreed to an expedited schedule as proposed by USFDA and expects to receive final approval for simvastatin tablets with exclusivity on June 23, 2006 when the U.S. Patent No. 4,444,784 covering simvastatin per se expires. In another development, Teva has obtained a tentative FDA approval for the Ivax’s Abbreviated New Drug Application (ANDA) for simvastatin tablets (5mg, 10mg, 20m, 40mg, and 80mg). Considering that appeal will be briefed over the summer and Teva will be commencing its marketing in June 2006, one thing is quite certain that Teva will receive final approval on June 23, 2006 and thereafter sells its generic version with marketing exclusivity just as the District Court ordered and subsequently fight the appeal filed by the FDA. If U.S. Court of Appeals rules in the favor of Teva, then Teva will enjoy marketing exclusivity till the end of December (exclusivity period will run till end of December), and if Court rules against Teva, then FDA will grant marketing approvals to the rest of generic players and end Teva’s marketing exclusivity before 180-days.

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