Watson Files ANDA For Ramelteon Tablets

Watson Pharmaceuticals (Watson) has confirmed that its subsidiary, Watson Laboratories has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its 8mg Ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical.

Reportedly, Watson’s 8mg Ramelteon tablet product is a generic version of Takeda’s Rozerem, which is indicated for the treatment of insomnia.

Takeda Pharmaceutical and Takeda Pharmaceuticals North America had filed suit against Watson on December 2, 2009 in the US District Court for the District of Delaware seeking to prevent Watson from commercialising its product prior to the expiration of US Patent No 6034239.

The company said that the 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.