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news.Mylan has confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and the company settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Frovatriptan Succinate Tablets, 2.5mg.
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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 28 January 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 7 November 2015.
By enforcing the settlement, Mylan can launch its product pursuant to the terms of the settlement, contingent upon final FDA approval.