Tuesday, June 05, 2007

Prozac Litigation Voluntarily Dismissed

Generic drug maker Barr Pharmaceuticals Inc. and NDA applicant Eli Lilly have voluntarily dismissed all claims stemming from a patent infringement lawsuit over Prozac Weekly Capsules, the lawsuit was filed in May last year by Lilly to prevent generic competition for its Prozac Weekly Capsules. According to Barr, Barr is the first to file an abbreviated new drug application (ANDA) with the US FDA for the 90mg capsules and, consequently, will be entitled to 180 days exclusivity when its application receives FDA final approval. Barr made ANDA submission in November 2001 along with Para IV certificate to Prozac Orange Book listed patents. However, on receiving the receipt of notice for Para IV certification from FDA, Lilly failed to sue Barr within 45 days. On March 21, 2006 Lilly obtained a reissue US Patent No. RE39, 030 (the ‘030 patent) and subsequently listed the patent with Orange Book. Accordingly Barr amended its ANDA to include Para IV certification for the ‘030 patent and notified Lilly. On May 10, 2006 after receiving notice from Barr, Lilly filed a patent infringement lawsuit against Barr alleging infringement of the ‘030 patent in the US District Court, Southern District of Indiana, to prevent Barr from proceeding with the commercialization of the generic Prozac.

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