FDAnews
www.fdanews.com/articles/172466-united-therapeutics-files-suit-against-allergan

United Therapeutics Files Suit Against Allergan

August 5, 2015

United Therapeutics has filed suit in federal court in New Jersey, claiming Allergan’s Paragraph IV ANDA for a generic version of its hypertension drug Tyvaso violates three of the drug’s patents.

The brandmaker is accusing Allergan of infringing on two method patents that expire in November 2018 and a process patent that expires in December 2028. United is asking the court to bar Allergan from commercializing its generic Tyvaso (treprostinil inhalation solution) until the patents expire.

Allergan announced the lawsuit, United Therapeutics Corporation v. Watson Laboratories, Inc. Watson, now known as Allergan, said it believes it is a “first applicant” to file an ANDA for Tyvaso, meaning it would be entitled to 180 days of exclusivity if approved by the FDA.

Tyvaso had U.S. sales of roughly $463 million in 2014, according to United Therapeutics. — Jonathon Shacat