Indian drug-maker Panacea Biotec Ltd. has won tentative US FDA approval for its first-to-file ANDA for a generic version of Eli Lilly & Co.’s blood-thinner Effient (prasugrel). Now, to get the copycat prasugrel to the US market, Panacea is expanding an alliance with Apotex Inc., the largest Canadian-owned pharmaceutical company.
Under the agreement, the closely held Canadian firm will handle US sales and distribution of prasugrel in 5mg-to-10mg doses while Panacea will manufacture and supply the drug. Panacea will be entitled to 180-days of shared marketing exclusivity for the clot-preventing drug after receiving final FDA approval. That’s revenue Panacea urgently needs as it struggles to return to profit
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