Post by mnholdem on Aug 9, 2018 7:06:24 GMT -5
United Therapeutics Announces Settlement Of Patent Litigation With Watson Laboratories, Inc. Relating To Tyvaso
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 8, 2018 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that it 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 U.S. 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 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 Watson's ANDA.
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No commercialization of generic Tyvaso until 2026. That gives MannKind plenty of time to commercialize its Trepostinil Technosphere (TreT), which outperformed Tyvaso in Phase 1 testing. MannKind's Phase 3 clinical trial for TreT is scheduled to begin in the 2nd half of 2018.
