Barr filed lawsuit to block Seasonique (Levonorgestrol/Ethinylestradiol) generic

Barr Pharma announced that it has filed suit against Watson Pharma for infringement of the patent protecting Duramed's Seasonique extended-cycle oral contraceptive product. The Company's Seasonique (Levonorgestrol/Ethinylestradiol combination) US7320969 is due to expire on January 30, 2024. In addition to the patent, the Company also has 3-year New Product Exclusivity for its Seasonique product until May 25, 2009. On January 22, 2008, the U.S. Patent and Trademark Office issued the patent for the Company's Seasonique extended-cycle oral contraceptive. The Company immediately submitted the patent to the USFDA for listing in the Orange Book. On January 22, 2008, Watson notified the Company pursuant to the Hatch-Waxman Act that Watson had filed an Abbreviated New Drug Application (ANDA) with the FDA for Seasonique and that Watson had 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.