Liquidia challenges regulatory exclusivity for rival's inhaled drug

[August 22, 2024]  (Reuters) -Liquidia has filed a legal challenge to the U.S. Food and Drug Administration's decision to grant a three-year exclusivity to United Therapeutics' inhaled drug used to treat lung disorders, the drugmaker said on Thursday.

The FDA on Monday delayed a traditional approval for Liquidia's Yutrepia, which means that the company can only launch the drug once patents on United's Tyvaso DPI expire in May 2025.

Tyvaso DPI and Yutrepia are inhaled drugs used to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Liquidia filed the litigation in the district court of the District of Columbia.

The company has faced multiple setbacks to bringing Yutrepia to the U.S. market. The drug was granted tentative approval in 2021 to treat PAH, but Liquidia could not market it due to a regulatory stay related to a patent infringement dispute with United.

The FDA on Monday only allowed tentative clearances for Yutrepia for both PAH and PH-ILD.

United has also sued Liquidia for patent infringement of its drug Tyvaso.

In February, United filed a case with the FDA in alleging that due procedure was not followed in allowing rival Liquidia's application to market Yutrepia to also treat PH-ILD, although it voluntarily dismissed the complaint earlier this month.

Shares of Liquidia were down 2.7% at $9.71 in premarket trading.

(Reporting by Sneha S K; Editing by Mrigank Dhaniwala and Varun H K)

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