American Regent’s Vasopressin Questioned As Eagle Prepares ANDA Launch
Daiichi Sankyo Affiliate Holds 505(b)(2) NDA Approval For Vasostrict Rival
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.
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Endo maintains that it will continue to drive revenue and EBITDA growth via business development opportunities, after the advent of generic competition to its lucrative Vasostrict injectable led the firm to disclose potentially catastrophic Q2 profitability guidance.
In the month ahead, Japanese firms are set to be hit with further price cuts to their generics, while Eagle Pharmaceuticals will throw off the restraints for its Pemfexy (pemetrexed) 505(b)(2) version of Eli Lilly’s Alimta.
Hot on the heels of Eagle’s first US generic launch, Dr Reddy’s has launched an authorized generic version of vasopressin at the same time as Endo’s Par Sterile Products has also launched a new pre-mixed ready-to-use presentation of the Vasostrict brand. Meanwhile, American Regent has also launched its 505(b)(2) product referencing Vasostrict.