United Therapeutics settles patent litigation with Sandoz

US drugmaker United Therapeutics (Nasdaq: UTHR) has entered into a settlement agreement with Sandoz Inc, a US generics unit of Swiss pharma giant Novartis (NOVN: VX), relating to ongoing litigation concerning certain patents relating to its Remodulin (treprostinil) Injection, and Sandoz's Abbreviated New Drug Application seeking approval by the US Food and Drug Administration to market a generic version of the drug.

Under the accord, United Therapeutics granted to Sandoz a non-exclusive license to manufacture and commercialize the generic version of Remodulin described in its ANDA filing in the USA beginning on June 26, 2018, although Sandoz may be permitted to enter the market earlier under certain circumstances. The drug is indicated for the treatment of pulmonary arterial hypertension.

The license included in the agreement does not permit Sandoz the right to manufacture a generic version of any other United Therapeutics product, such as Tyvaso (treprostinil) Inhalation Solution or Orenitram (treprostinil) Extended-Release Tablets, nor does it grant any rights with respect to any technology associated with the Remodulin Implantable System being developed by the company and Medtronic, or the pre-filled semi-disposable pump system being developed by the company and DEKA Research & Development Corp. The settlement does not grant Sandoz any rights other than those required to launch Sandoz's generic version of Remodulin.