United Therapeutics Corp. settled a patent lawsuit with Actavis Laboratories FL Inc. regarding hypertension tablets of Orenitram, or treprostinil.
Orenitram is intended for the treatment of pulmonary arterial hypertension.
Under the terms of the settlement, the U.S. based biotechnology company granted Actavis a license to manufacture and commercialize the generic version in 2027. The settlement includes scope for an earlier market entry under certain circumstances.
The license granted to Actavis does not include other United products like the treprostinil inhalation solution or injection.
The companies will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
United received notice of Actavis's approval application to the U.S. Food and Drug Administration on Feb. 18, 2016. The abbreviated new drug application, or ANDA, filed by Actavis challenged eight of the nine patents related to Orenitram.
The companies also settled a case against Actavis's ANDA.
United Therapeutics recently lost a patent case to SteadyMed Ltd. regarding one of the patents also involved in the Actavis litigation. The court ruled the patent invalid and United was required to inform the U.S. FDA to withdraw the patent from the Orange Book.