Allergan’s ANDA product is a generic version of United Therapeutics Corporation’s Tyvaso, which is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability.
United Therapeutics filed suit against Allergan on July 22, 2015 in the U.S. District Court for the District of New Jersey seeking to prevent Allergan from commercializing its ANDA product prior to the expiration of certain U.S. Patents.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan’s ANDA for up to 30 months from the date the plaintiffs received notice of Allergan’s ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Allergan believes it may be a "first applicant" to file an ANDA for the generic version of Tyvaso and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending December 31, 2014, Tyvaso had U.S. sales of approximately $463 million, according to United Therapeutics.