United Therapeutics, in unusual step, sues FDA over rival’s drug application
United Therapeutics sued the Food and Drug Administration on Wednesday, saying the agency made a mistake in allowing a rival to amend a pending application to sell a competing medicine instead of starting over with a new submission.
At issue is Liquidia’s bid to sell a version of an inhaled powder called treprostinil, the subject of years of patent litigation between the two companies. Liquidia already won tentative approval to sell the medicine under the brand name Yutrepia to treat pulmonary arterial hypertension, but that decision is on hold because of a period of exclusivity held by United that Liquidia says expires March 31.
While waiting for final approval, Liquidia in July filed to add a new indication to the application that would allow the company to also sell the drug for pulmonary hypertension associated with interstitial lung disease, or PH-ILD. United says that, by accepting the amendment, the FDA is allowing Liquidia to skirt the rules and preventing the company from using patent law to stall Liquidia’s market entry.
“The FDA is a global leader among public health agencies, but sometimes legal and regulatory precedents are missed,” Dean Bunce, executive vice president for global regulatory affairs, said in a United statement Wednesday. “We are simply asking that the FDA apply its own rules and precedents consistently.”
Under patent law, the FDA has to wait as long as 30 months to approve a new drug application that is the subject of an infringement claim. United says Liquidia avoided triggering that stay by filing an amendment instead of a full NDA even though Liquidia is relying on United’s research for the new PH-ILD indication. Liquidia in January said the FDA confirmed the amendment process.
While unusual, United’s lawsuit isn’t unprecedented. Catalyst Pharmaceuticals in 2019 sued the FDA, seeking to vacate the approval of a competitor’s drug. And both Eagle Pharma and Regenxbio have attempted to use the legal system to overturn FDA regulatory decisions.
United is a public benefit corporation that sells treprostinil under the brand name Tyvaso. It won FDA approval in March 2021 to sell the drug as the first-ever treatment for PH-ILD.
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