United Therapeutics Sues FDA for Denying Exclusive Marketing Rights for Orphan Drug

The FDA failed to follow federal law when it refused to provide exclusive marketing rights to United Therapeutics for its treprostinil formulation, branded as Orenitram, as an orphan drug, the company said in a federal lawsuit.

United Therapeutics asked the U.S. District Court for the District of Columbia to grant the exclusivity for seven years from when the FDA approved the drug in 2013 as the Orphan Drug Act provides.

Orenitram is an extended-release oral formulation of treprostinil for the treatment of pulmonary arterial hypertension that had been previously approved in other forms.