Pharmaceutical Business review

Warner Chilcott files lawsuits against Mutual Pharmaceutical, Mylan and Impax

Warner Chilcott markets and sells Doryx delayed-release tablets in 150, 100 and 75mg strengths under a licensing agreement with Mayne.

The lawsuits are in response to the submission of abbreviated new drug applications to the FDA by each of Mutual, Mylan and Impax requesting approval to manufacture and sell generic versions of Doryx 100 and 75mg delayed-release tablets prior to the expiration in 2022 of the Doryx patent.

Warner Chilcott and Mayne intend to defend the patent and pursue their legal rights.