Multiple Vasostrict ANDAs Rival Eagle In Competitive Market
‘Market Is Crowded,’ Admits Peptide-Focused ANDA Sponsor Amphastar
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.
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With glucagon-like peptide 1 products to treat diabetes and obesity continuing to gather pace, Sandoz has expressed confidence that it is capable of bring such complex products to market using its vast array of in-house capabilities.
Endo’s woes show no sign of abating, with the US Court of Appeals for the Federal Circuit shooting down its appeal against a finding of non-infringement for two key patents shielding its Vasostrict injectable.
A group of Endo debtholders are looking to buy the firm out of bankruptcy, with an initial $6bn bid for the stricken firm that envisions setting aside more than half-a-billion dollars for opioid-related claims. Meanwhile, Endo has reached an agreement-in-principle to resolve opioid-related claims.