Eagle Victory Clears Way For US Vasopressin Launch
Endo’s Par Fails To Demonstrate Vasostrict Infringement; But CRL Must Be Overcome
Eagle Pharmaceuticals has celebrated a US court ruling that clears the way for it to launch its generic vasopressin rival to Endo’s Vasostrict. However, the company is still waiting for FDA approval after its application was delayed by a CRL earlier this year, with a new action date provided by the agency.
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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.
Eagle management provided detailed insight into the existing market for vasopressin, which it entered in January with the first generic version of Endo’s Vasostrict. The US-based player believes operating cash flows for the year, boosted also by its Pemfexy (pemetrexed) launch, could top $170m, paving the way for a major acquisition.
With Eagle set to launch its long-awaited vasopressin ANDA product on 17 January, the US firm’s management told investors it was unsure what its launch meant for the 505(b)(2) rival product in the hands of American Regent.