Court win for United Therapeutics will restrain looming competition for its soon-to-be blockbuster

2022-09-02

United Therapeutics claimed victory earlier this week in a patent battle against Liquidia Technologies, which won tentative FDA approval for its treprostinil inhalation powder, Yutrepia, to treat pulmonary arterial hypertension (PAH) and would compete directly with United’s soon-to-be blockbuster Tyvaso DPI.

The Delaware-based district court found that Liquidia failed to prove by “clear and convincing evidence” that certain claims on one of the patents are invalid. But both companies claimed victory over other parts of the decision, and when Yutrepia will launch is still up in the air.

While United says it expects the court to enter an injunction barring the FDA from granting final approval for Yutrepia until expiration of one of the patents, known as the ’793 patent, on May 14, 2027, Liquidia CEO Roger Jeffs said he’s optimistic of a full approval in mid-2024.

“We are pleased that all three patents asserted against us have been found to be either invalid or not infringed among the different legal proceedings,” Jeffs said in a statement. “While we are disappointed with the Court’s decision on the ‘793 patent, we are optimistic that the PTAB’s favorable decision will be affirmed on appeal, thereby unlocking the path to potential approval of YUTREPIA by mid-2024, if not earlier.”

The FDA only just approved Tyvaso DPI last May for PAH, and the first commercial shipments to specialty pharmacies occurred in June, the company said.

But Tyvaso also won approval for its pulmonary hypertension associated with interstitial lung disease (PH-ILD) indication on March 31, 2021, and in April, CMS updated its local coverage determination for Tyvaso to include an indication for PH-ILD, which became effective in June.

United Therapeutics has high hopes for Tyvaso, which has seen steady growth from $480 million in sales in 2020 to more than $607 million in 2021. Cowen analyst Joseph Thome models peak revenues of $1.6 billion in 2025 for United’s inhaled franchise.

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机构

Liquidia Corp.