Warner Chilcott, a specialty pharmaceutical company, has announced that one of its subsidiaries and Mayne Pharma International have filed a second lawsuit against Impax Laboratories, in the District Court of New Jersey for infringement of Mayne’s US patent which covers Doryx, a tetracycline-class oral antibiotic.
The lawsuit is in response to the submission of an abbreviated new drug application (ANDA) to the FDA by Impax requesting approval to manufacture and sell a generic version of Doryx 150mg delayed-release tablets prior to the expiration in 2022 of the patent.
Warner Chilcott previously announced, in December 2008, the filing of a lawsuit against Impax in response to Impax’s submission of an ANDA requesting approval to manufacture and sell generic versions of Doryx 100 and 75mg delayed-release tablets. Warner Chilcott markets and sells Doryx delayed-release tablets in 150, 100 and 75mg strengths in the US under a licensing agreement with Mayne.
Warner Chilcott and Mayne intend to vigorously defend the patent and pursue their legal rights. Warner Chilcott believes that the FDA will stay approval of Impax’s generic version of Doryx 150mg delayed-release tablets for up to 30 months, while the case is pending in the district court.