Watson Laboratories files an ANDA for generic version of Rozerem

Dec 4 2009

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 8mg ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical Company Limited. Watson's 8mg ramelteon tablet product is a generic version of Takeda's Rozerem®, which is indicated for the treatment of insomnia characterized by difficulty with sleep onset.

Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc. filed suit against Watson on December 2, 2009 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 6,034,239. Takeda's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be a "first applicant" to file an ANDA for a generic version of Rozerem® and, should its ANDA be approved, may be entitled to 180 days of shared generic market exclusivity.

For the twelve months ending September 30, 2009, Rozerem® had total U.S. sales of approximately $91 million according to IMS Health data.

SOURCE Watson Pharmaceuticals, Inc.