UPDATE: Mylan Confirms First-to-File Patent Challenge Related to Savella
Mylan Inc. (Nasdaq: MYL) today confirmed that the company has been sued by Forest Laboratories Inc. (NYSE: FRX), Forest Laboratories Holdings Ltd., and Royalty Pharma Collection Trust in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Milnacipran HCl Tablets 12.5 mg, 25 mg, 50 mg and 100 mg. This product is the generic version of SAVELLA®, which is indicated for the management of fibromyalgia. This product is not approved for use in pediatric patients.(1)
Mylan believes it is one of the first companies to have 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 have filed a lawsuit against Mylan in the United States District Court for the District of Delaware.
For the 12 months ending June 30, 2013, SAVELLA had U.S. sales of approximately $123 million, according to IMS Health.
Currently, Mylan has 178 ANDAs pending FDA approval representing $83.8 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities,