Liquidia Wins Legal Battle Over $137M in Losses for Generic Treprostinil Injection Launch Delays

Liquidia Corporation, a biopharmaceutical company focused on therapies for rare cardiopulmonary diseases, has announced a significant legal victory against United Therapeutics Corporation. The U.S. District Court for the District of New Jersey has ruled that United Therapeutics interfered with the 2019 launch of the first fully-substitutable generic Treprostinil Injection, causing over $137 million in losses. Treprostinil Injection, developed in partnership with Sandoz Inc., is used to treat pulmonary arterial hypertension (PAH) and offers a more affordable alternative to the branded drug Remodulin®.

The case stems from a lawsuit filed in April 2019 by Liquidia PAH, a subsidiary of Liquidia, and Sandoz, alleging that United Therapeutics violated antitrust laws and unfair competition statutes by restricting access to cartridges essential for administering generic Treprostinil. The court has ruled in favor of Liquidia and Sandoz, affirming that United Therapeutics' actions resulted in significant financial harm and delayed the availability of the generic treatment.

Dr. Roger Jeffs, CEO of Liquidia, commented on the court’s decision: "This ruling is a major milestone in our ongoing fight to ensure that patients have access to more affordable treatment options. United Therapeutics' actions not only harmed our business but also denied patients a viable and less costly alternative."

Despite the ruling, the final damage award is still pending, as the court will account for certain costs avoided by Sandoz due to United Therapeutics' breach of contract. The damages will be split evenly between Sandoz and Liquidia PAH, although Liquidia PAH’s portion will be allocated to its finance partners, Henderson SPV, LLC, and PBM RG Holdings, LLC, as part of prior agreements.

Treprostinil Injection was launched in 2019 as the first fully-substitutable generic version of Remodulin for parenteral administration. It contains the same active ingredients, dosage, and formulation as its branded counterpart but is offered at a reduced cost to patients and healthcare providers. Liquidia PAH has partnered with Sandoz to promote the use of Treprostinil Injection across the U.S.

In addition to marketing Treprostinil Injection, Liquidia is also developing YUTREPIA™, an inhaled treprostinil powder, and L606, a sustained-release formulation designed for use with a next-generation nebulizer, continuing its commitment to innovative therapies for rare cardiopulmonary diseases. 

Liquidia remains focused on addressing the unmet needs of PAH patients by advancing its pipeline of treatments and improving access to critical therapies.