Warner Chilcott markets and sells Doryx delayed-release tablets in 150, 100 and 75mg strengths under a licensing agreement with Mayne. Warner Chilcott has previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company, Mylan Pharmaceuticals, Impax Laboratories and Sandoz.
The lawsuit is in response to the submission of an abbreviated new drug application to the FDA by Actavis requesting approval to manufacture and sell generic versions of Doryx 100 and 75mg delayed-release tablets prior to the expiration in 2022 of the patent. Warner Chilcott and Mayne intend to vigorously defend the patent and pursue their legal rights.