Lupin gets USFDA nod for amifampridine tablets, eligible for 180-day generic exclusivity

Global pharma major Lupin Ltd on Monday (November 2) received approval from the United States Food and Drug Administration (USFDA) for its Amifampridine Tablets, 10 mg, and is eligible for 180 days of shared generic exclusivity as one of the first applicants to file for the drug.

The approval was granted for the company's Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg, which are bioequivalent to the reference listed drug (RLD), Firdapse Tablets, 10 mg, marketed by Catalyst Pharmaceuticals Inc.

The tablets are approved for the indication specified in the approved labelling, the company said.

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Last month, Lupin received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.

The US FDA has approved Lupin’s product as bioequivalent to the reference listed drug, Phytonadione Injectable Emulsion, 1 mg/0.5 mL, marketed by International Medication Systems.

The drug is used to treat and prevent low blood clotting caused by hypoprothrombinemia and vitamin K deficiency. Phytonadione Injectable Emulsion had estimated annual sales of $52.3 million in the US, according to IQVIA MAT August 2026 data.

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Shares of Lupin Ltd ended at ₹1,996.55, down by ₹12.45, or 0.62%, on the BSE.