Watson seeks FDA approval for generic insomnia treatment

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals has filed for regulatory approval with the Food and Drug Administration for a version of an insomnia drug, prompting a lawsuit from the branded drug’s manufacturer.

Watson announced Friday that it had sent its application to the FDA for ramelteon tablets in the 8-mg strength, a generic version of Takeda Pharmaceutical Co.’s Rozerem. In response, Takeda and its North American subsidiary filed litigation against Watson on Wednesday, alleging that Watson’s application infringes on U.S. Patent No. 6,034,239, which covers Rozerem.

Under the provisions of the Hatch-Waxman Act of 1984, Takeda’s lawsuit requires the FDA to delay final approval of Watson’s generic ramelteon for up to two-and-a-half years or until the two companies resolve the matter in court. Watson said it was probably the first company to file for approval of a generic version of Rozerem, entitling it to six months in which it can compete directly with Takeda’s product.

Rozerem had sales of $91 million during the 12-month period ending Sept. 30, according to IMS Health.