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news.Duramed Pharmaceuticals, a wholly-owned subsidiary of Barr Pharmaceuticals has filed suit against Watson Pharmaceuticals and its subsidiary, Watson Laboratories, for infringement of the patent protecting Duramed's Seasonique extended-cycle oral contraceptive product.
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Duramed’s Seasonique patent is due to expire on January 30, 2024. In addition to the patent, the company also has three-year new product exclusivity for its Seasonique product until May 25, 2009.
On January 22, 2008, Watson has notified Duramed that it had filed an abbreviated new drug application (ANDA) with the FDA for Seasonique and also amended its application to include a paragraph IV certification asserting that the Seasonique patent is invalid, unenforceable or not infringed by Watson’s ANDA product. Barr has filed to enforce the patent and prevent Watson from marketing a competing product prior to patent expiry in 2024.
If Barr is unsuccessful in this litigation, the Company may face generic competition for Seasonique as early as May 25, 2009, the date of expiration of the existing new product regulatory exclusivity for Seasonique.