United Therapeutics has announced a settlement agreement with Watson Laboratories that includes a license for Watson to manufacture and sell a generic version of Tyvaso treprostinil inhalation solution as of January 1, 2026. Watson is currently a subsidiary of Teva.
The settlement resolves litigation that had been ongoing since Watson filed an ANDA for the inhalation solution in 2015.
Two of the three patents that Watson initially cited as invalid and/or unenforceable – US Patent Nos. 6,521,212; 6,756,033; and 8,497,393 – expire in November 2018; the third expires in 2028.
Read the United Therapeutics press release.