Aug 22 (Reuters) - Liquidia ( LQDA ) has filed a legal
challenge to the U.S. Food and Drug Administration's decision to
grant a three-year exclusivity to United Therapeutics' ( UTHR )
inhaled drug used to treat lung disorders, the drugmaker said on
Thursday.
The FDA on Monday delayed a traditional approval for
Liquidia's ( LQDA ) 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 ( LQDA ) 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 ( LQDA ) 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 ( LQDA ) 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 ( LQDA )
application to market Yutrepia to also treat PH-ILD, although it
voluntarily dismissed the complaint earlier this month.
Shares of Liquidia ( LQDA ) were down 2.7% at $9.71 in premarket
trading.
(Reporting by Sneha S K; Editing by Mrigank Dhaniwala and Varun
H K)