Mylan Inc. (Nasdaq: MYL) today confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate Tablets, 2.5 mg. This product is the generic version of FROVA®, which is used to treat acute migraine headaches in adults.
As a result of the decision, the Court has vacated its January 28, 2014, decision in favor of Endo regarding the parties' patent litigation over this product, which could have prevented Mylan from launching its generic version of FROVA until after the expiration of U.S. Patent 5,464,864 patent on November 7, 2015. By enforcing the settlement, Mylan can launch its product pursuant to the terms of the settlement, contingent upon final FDA approval.
For the 12 months ending Dec. 31, 2013, Frovatriptan had U.S. sales of approximately $66.41 million, according to IMS Health.
Currently, Mylan has 187 ANDAs pending FDA approval representing $94.9 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.