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.
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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.
Heading into the J.P. Morgan Healthcare conference, pharmas have been focusing on discovery alliances. J&J’s deals look into novel tissue-targeted drugs, ionic liquid delivery technology and cancer vaccine R&D. Lilly teams with Entos on novel methods for delivering neurology drugs.
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.