United Therapeutics Takes Leal Action Against FDA Over Rival Liquidia’s Drug Application

United Therapeutics Corp has taken legal action against the U.S. Food and Drug Administration (FDA) regarding the approval process for a rival drug application from Liquidia Corp. The lawsuit alleges that Liquidia circumvented established FDA regulations, precedents, and procedures when submitting its application for an inhaled dry powder form of treprostinil, intended for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Interstitial lung disease encompasses a group of disorders characterized by lung scarring, posing significant health challenges to patients.

In addition to contesting the FDA’s handling of Liquidia’s application, United Therapeutics has initiated legal proceedings against Liquidia for patent infringement related to its drug Tyvaso.

Liquidia Corp recently disclosed that the FDA was in the process of reviewing its drug application, with an expected decision date of January 24th.

As of now, neither the FDA nor Liquidia has provided immediate responses to Reuters’ request for comments on the matter. This legal dispute underscores the complexities and competitiveness within the pharmaceutical industry, particularly concerning regulatory oversight and intellectual property rights.

Related posts:

RSV Vaccine Patent: GSK Takes Legal Action Against Pfizer Eli Lilly Takes Legal Action Against Several Companies Over Compounded “Mounjaro” UNION Therapeutics to Present at 7th Annual Dermatology Drug Development Summit in Boston Vanda Pharma’s New Drug Application for Tradipitant in Gastroparesis Accepted by FDA