United Therapeutics Corporation said it entered into a patent settlement agreement with Actavis Laboratories FL, Inc.
The settlement resolves litigation concerning certain patents relating to United Therapeutics’ Orenitram (treprostinil) extended-release tablets, and Actavis’ abbreviated new drug application (ANDA) seeking approval by the US Food and Drug Administration to market a generic version of Orenitram.
Orenitram medicine can be used to treat pulmonary arterial hypertension (PAH) and can also boost the ability to exercise.
“Under the Settlement Agreement, United Therapeutics granted to Actavis a license to manufacture and commercialize the generic version of Orenitram described in its ANDA filing in the United States beginning on June 15, 2027, although Actavis may be permitted to enter the market earlier under certain circumstances,” said United Therapeutics.
“The license included in the Settlement Agreement does not permit Actavis to manufacture a generic version of any other United Therapeutics product, such as Tyvaso (treprostinil) Inhalation Solution or Remodulin (treprostinil) Injection.
“The Settlement Agreement does not grant Actavis any rights other than those required to launch Actavis’ generic version of Orenitram.
“In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, and will also terminate the pending litigation concerning patents relating to Actavis’ ANDA.”