United Therapeutics Corporation has entered into a Settlement Agreement with Watson Laboratories, Inc. (Watson) resolving ongoing litigation concerning certain patents relating to United Therapeutics' product, Tyvaso (treprostinil) Inhalation Solution, and Watson's Abbreviated New Drug Application (ANDA) seeking approval by the US Food and Drug Administration to market a generic version of Tyvaso.
Under the Settlement Agreement, United Therapeutics granted to Watson a license under its patent rights to manufacture and commercialize the generic version of Tyvaso described in its ANDA filing in the United States beginning on January 1, 2026, although Watson may be permitted to enter the market earlier under certain circumstances.
The license included in the Settlement Agreement does not permit Watson to manufacture a generic version of any other United Therapeutics product, such as Remodulin (treprostinil) Injection or Orenitram (treprostinil) Extended-Release Tablets. The Settlement Agreement does not grant Watson any rights other than those required to launch Watson's generic version of Tyvaso.
In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the US Federal Trade Commission and the US Department of Justice for review and will also terminate the pending litigation concerning patents relating to Watson's ANDA.
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions.