Eagle receives FDA approval for generic Vasostrict

Eagle Pharmaceuticals has received the Food and Drug Administration's nod for vasopressin.

The product is the generic of Vasostrict. 

It is indicated to increase blood pressure in adults with vasodilatory shock (e.g., postcardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.

The approval follows the recent U.S. District Court for the District of Delaware decision holding that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, asserted against the company.

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“We expect vasopressin to be a significant addition to our hospital and critical care portfolio, and we are delighted to now have final FDA approval for our A-rated, therapeutic equivalent product. We also anticipate 180-day marketing exclusivity. This is an important product for us, and a much-needed generic alternative to Vasostrict for providers and patients. We are implementing our launch plans to bring vasopressin to market,” Eagle president and CEO Scott Tarriff, said.

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Vasostrict had a market value of $786 million in 2020, according to Eagle.