Mylan Pharmaceuticals has signed a settlement agreement with Somaxon Pharmaceutical to resolve patent litigation related to generic version of Somaxon's Silenor.
The litigation is regarding Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Doxepin Hydrochloride Tablets, 3mg and 6mg, indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
As per the settlement terms, Mylan has the exclusive right to sell an authorized generic version of Silenor in the US and its territories for 180 days beginning on 1 January 2020, which could extend for as long as 360 days. After this particular period Mylan can sell a generic Silenor under its own ANDA.
Under certain circumstances, Somaxon's license to Mylan would become effective prior to 1 January 2020.
Persuant to the agreement, Mylan also entered into an agreement to manufacture and supply Silenor finished product to Somaxon.
The remaining details of the agreement, which is subject to review by the Federal Trade Commission and the U.S. Department of Justice, have been kept confidential.
