Mylan Earns Court Victory for Frovatriptan

By Pharma News - DCAT Publisher

April 12, 2014

Mylan Inc. reports 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 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.

Mylan reports that 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 US 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 US.sales of approximately $66.41 million, according to IMS Health and as reported by Mylan in its press release.

Source: Mylan