BRIEF—Appeals court rules in favor of Eagle Pharma in vasopressin litigation

The US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware’s decision that US drugmaker Eagle Pharmaceuticals’ vasopressin product does not infringe on any of the patents asserted by Par Pharmaceutical, a subsidiary of Endo International.

Par previously sued Eagle in 2018, alleging infringement of several of its patents and a trial was held in July 2021. The District Court held that Eagle did not infringe on any of Par’s patents, and Par appealed.

Oral arguments were held before the Federal Circuit in July 2022.

On Thursday, the Federal Circuit issued its decision rejecting Par’s arguments and affirming the District Court’s finding of non-infringement.

Eagle was the first to file an Abbreviated New Drug Application (ANDA) referencing Vasostrict.

On December 15, 2021, the US Food and Drug Administration (FDA) approved Eagle’s ANDA for vasopressin, a product that is indicated for use to increase blood pressure in adults with vasodilatory shock (eg, post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.

Eagle commenced marketing its product in January 2022.