Warner Chilcott Limited announced that one of its subsidiaries and Mayne Pharma International Pty. Ltd. has filed a lawsuit against Actavis Elizabeth LLC in the District Court for the District of New Jersey for infringement of Mayne's US Patent No. 6,958,161 (the 161 Patent) which covers DORYX, a tetracycline-class oral antibiotic.
A press release by the company stated that Warner Chilcott markets and sells DORYX delayed-release tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne.
Warner Chilcott has previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company Inc., Mylan Pharmaceuticals Inc., Impax Laboratories Inc. and Sandoz Inc.
The lawsuit is in response to the submission of an Abbreviated New Drug Application (ANDAs) to the US Food and Drug Administration (FDA) by Actavis requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg delayed-release tablets prior to the expiration in 2022 of the '161 Patent.
Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the US pharmaceuticals market.
SOURCE:AGIPNEWS