Mylan Confirms First-to-File Patent Challenge for CANASA

Mylan Inc. MYL today confirmed that the company has been sued by Aptalis in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Mesalamine Rectal Suppositories, 1000 mg. This product is the generic version of CANASA®. Mylan filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for the District of New Jersey. For the 12 months ending March 31, 2013, CANASA^® had U.S. sales of approximately $153 million, according to IMS Health. Currently, Mylan has 173 ANDAs pending FDA approval representing $82.9 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $22.6 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.