By: IPP Bureau
Last updated : November 02, 2026 8:12 pm
As the First-To-File, Lupin Is eligible for 180-day shared generic exclusivity
Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Amifampridine Tablets, 10 mg.
Amifampridine Tablets, 10 mg, bioequivalent to the reference listed drug (RLD), Firdapse Tablets, 10 mg, of Catalyst Pharmaceuticals, for the indication in the approved labeling.
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.