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Eagle Bags Vasopressin Exclusivity And Details Launch Plans

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

 
• By Dean Rudge

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

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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)

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