‘Hey, Dude, Where’s My Exclusivity?’: United Therapeutics, FDA Tussle


Silver Spring, Md.-based United Therapeutics Corp. and the FDA are duking it out in court over whether the agency improperly denied the biotechnology company seven years of orphan drug exclusivity for its drug Orenitram.

Orenitram (treprostinil) treats pulmonary arterial hypertension (PAH) and the FDA designated it as an orphan drug in 2013 but refused to award it the seven years of market exclusivity generally awarded to orphan drugs.

United Therapeutics wants its exclusivity. It sued the FDA in the U.S. District Court for the District of Columbia in August 2017 to force the agency to award it the seven years of orphan drug marketing exclusivity.

The company alleges the FDA illegally disregarded the plain language of the statute and prevailing case law and instead applied an extra-statutory standard wrongly requiring the company to show Orenitram was clinically superior to older drugs.

If United Therapeutics’ suit succeeds, it would receive exclusivity for seven years from the date the FDA designated Orenitram an orphan drug in 2013. That would mean the FDA couldn’t approve generic versions of treprostinil to compete with Orenitram until Dec. 20, 2020.

Orphan drugs treat rare conditions and diseases affecting a limited patient population. Under federal food and drug law, such drugs are eligible for special statutory incentives including the seven years of market exclusivity.

“There is no wiggle room: the statute requires FDA to grant Orenitram marketing exclusivity for seven years,” United Therapeutics says in a November 2017 court filing. “FDA’s demand for a showing of clinical superiority as a precedent to exclusivity finds no anchor in the statutory text.”

But the Food and Drug Administration claims United Therapeutics is trying to game the system because the company already was awarded orphan drug exclusivity periods for Remodulin and Tyvaso, two other PAH drugs it developed using the same active ingredient (treprostinil) as Orenitram.

Orenitram is not the first PAH drug of its kind and it’s not clinically superior to Remodulin or Tyvaso, the FDA said in a December court filing. “UTC nevertheless claims that developing the drug entitles it to extend its fourteen-year monopoly on treprostinil drugs to twenty-one years,” the FDA said. “[C]ontrary to what UTC argues, such a monopoly is not compelled by the Orphan Drug Act—and not justified given the facts of this case.”

Stay tuned.

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