Eagle Soars As It Looks To 13-Year Head Start On Vasopressin In US
FDA Approves Eagle’s Vasostrict ANDA Product; Won Patent Trial In August
Following the disappointment of a complete response letter and delayed trial proceedings, Eagle has secured FDA approval for the first generic version of Par’s Vasostrict, which is tipped to have branded sales approaching $1bn in the US in 2021.
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Amphastar, Amneal and Aurobindo are among ANDA sponsors confirming USFDA approval for generic versions of Endo’s Vasostrict (vasopressin) 20 units/ml single-dose vial – as first mover Eagle Pharmaceuticals remains locked in patent-litigation proceedings with the originator.
In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.
Generic competition to Vasostrict is nearing in the US after the FDA confirmed Eagle’s previously unresolved potential for 180-day market exclusivity.