United Therapeutics Settles With Sandoz Over Remodulin Patent Dispute

United Therapeutics has agreed to grant Sandoz a nonexclusive license to manufacture and sell a generic version of its hypertension drug Remodulin beginning in 2018, putting an end to ongoing patent litigation.

Under the settlement announced last week, Sandoz can enter the market with generic Remodulin (treprostinil sodium) starting June 26, 2018 — or sooner under circumstances that were not disclosed.

The settlement resolves three lawsuits, including appeals of rulings in the U.S. district court in New Jersey that the ’117 patent is valid and the ’007 patent would not be infringed. A separate lawsuit filed by UTC against Sandoz in the same court in September 2014 alleged infringement of the ’393 patent.

Remodulin earned UTC $136 million in the second quarter of the year.

The settlement must be approved by the Federal Trade Commission and Justice Department. — Jonathon Shacat