Federal Judge Enforces Settlement Between Mylan & Endo Pharma On Generic FROVA

(RTTNews) - The federal district court has enforced settlement agreement between Mylan Inc. (MYL) and Endo Pharmaceuticals, thereby settling patent lawsuit on Mylan's filing of an Abbreviated New Drug Application or ANDA with the U.S. Food and Drug Administration or FDA for Frovatriptan Succinate Tablets, 2.5 mg. This is in relation with the generic version of FROVA, that is used to treat acute migraine headaches in adults.

As a result of this, the Court has vacated its January 28, 2014, decision favoring Endo pertaining to the parties' litigation over this product, which could have avoided Mylan from introducing its generic 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 as per the settlement, contingent upon final FDA approval.

According to IMS Health, Frovatriptan recorded U.S. sales of about $66.41 million in 2013. Mylan has 187 ANDAs currently pending FDA approval, representing $94.9 billion in annual brand sales, according to IMS Health.