Mylan Inc. 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.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in