Watson Pharmaceuticals, todayconfirmed that its subsidiary, Watson Laboratories, Inc.-Florida, filed anAbbreviated New Drug Application (ANDA) with the U.S. Food and DrugAdministration seeking approval to market its 8mg ramelteon tablets prior tothe expiration of a patent owned by Takeda Pharmaceutical Company Limited.Watson's 8mg ramelteon tablet product is a generic version of Takeda'sRozerem, which is indicated for the treatment of insomnia characterized bydifficulty with sleep onset.
Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals NorthAmerica, Inc. filed suit against Watson on December 2, 2009 in the U.S.District Court for the District of Delaware seeking to prevent Watson fromcommercializing 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-WaxmanAct, resulting in a stay of final FDA approval of Watson's ANDA for up to 30months or until final resolution of the matter before the court, whicheveroccurs 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 genericmarket exclusivity.
For the twelve months ending September 30, 2009, Rozerem had total U.S.sales of approximately $91 million according to IMS Health data.