Allergan has confirmed that it submitted an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of United Therapeutics’ Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and says it believes that it is the first applicant to file.
In June 2015, United Therapeutics announced that it had received notice of the submission and intended to defend its patents related to the product. The company subsequently filed suit to prevent Allergan from marketing its treprostinil inhalation solution before the expiration of the patents, the last of which expires in 2028.
Read the Allergan press release.
