According to United Therapeutics, the company has received notice that Watson Laboratories, a subsidiary of Allergan, has submitted an Abbreviated New Drug Application (ANDA) for a generic version of United Therapeutics’ Tyvaso treprostinil inhalation solution.
The notice letter cites three patents, US Patent Nos. 6,521,212; 6,756,033; and 8,497,393 as invalid and/or not enforceable. In the letter to United Therapeutics, Watson says that it intends to market its generic treprostinil inhalation solution prior to expiration of the patents. Two of the patents expire in November 2018; the third expires in 2028.
United Therapeutics says that it is reviewing the notice letter and “intends to vigorously enforce its intellectual property rights relating to Tyvaso.”
Read the United Therapeutics press release.
