BRIEF—Eagle to maintain 180 days of marketing exclusivity for vasopressin

The US Food and Drug Administration has determined that Eagle Pharmaceuticals has maintained its 180 days of marketing exclusivity for its recently approved abbreviated new drug application (ANDA) for vasopressin.

In August, the US District Court for the District of Delaware held that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical asserted against the company. An appeal of that decision remains pending.

Eagle was the first company to file an ANDA referencing Vasostrict (vasopressin), which had total US sales of $786 million in 2020 and is used to treat shock in patients whose blood vessels suddenly relax.

“We are delighted that we have maintained our 180 days of marketing exclusivity for vasopressin, a product that we believe will offer an important A-rated therapeutic equivalent product to Vasostrict. 2022 will be an exciting period for us with our upcoming launch of vasopressin, as well as our launch of Pemfexy [pemetrexed for injection], beginning on February 1, 2022,” stated Scott Tarriff, president and chief executive of Eagle.