Eagle Bags Vasopressin Exclusivity And Details Launch Plans

US Agency Also Dishes Out Tentative Nod For Amphastar’s’ ANDA Product

Generic competition to Vasostrict is nearing in the US after the FDA confirmed Eagle’s previously unresolved potential for 180-day market exclusivity.

Dartboard
Eagle has defeated Par in district court patent infringement proceedings • Source: Shutterstock

The US Food and Drug Administration has confirmed 180 days of generic market exclusivity for Eagle Pharmaceuticals’ generic to Par’s Vasostrict (vasopressin) 20 units/ml injectable, allowing for a tentative approval to be handed to Amphastar Pharmaceuticals for its Vasostrict ANDA product.

New Jersey-based Eagle has now confirmed it will begin shipping its vasopressin product on 17 January 2022, ahead of launching its Pemfexy (pemetrexed)

More from Regulation

More from Policy & Regulation