Endo Launches First US Mitigare Generic Following Micro Labs Lawsuit
Par Was Entitled To Launch From June 2023 But Had Not At Time Of Suit
Endo’s Par has moved on the first FDA-approved generic version of Hikma’s Mitigare prevention of gout flares – weeks after another ANDA sponsor, Micro Labs, sought to clear its own path to market via a lawsuit.
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Japanese originator Takeda has agreed to settle two-year-old anticompetitive claims lodged by wholesalers in the US that it conspired with several generics manufacturers to maintain supracompetitive pricing for its Colcrys branded treatment for gout.
Generics Bulletin previews the most noteworthy and anticipated events for December 2023.
“A lot of companies are hurting because of the higher interest rates,” one major CEO observed recently, summing up a year which saw little headline-grabbing news on the M&A front for generic and biosimilar sponsors.