Lupin Wins FDA Approval for Amifampridine Tablets: a Firdapse Generic for a Rare Muscle-Weakness Disorder, With 180 Days of Shared Exclusivity
Lupin Limited announced on November 2, in Mumbai, India, and Naples, Florida, that the U.S. Food and Drug Administration has approved its abbreviated new drug application (ANDA) for amifampridine tablets, 10 mg.
The generic is bioequivalent to the reference listed drug, Firdapse tablets, 10 mg, from Catalyst Pharmaceuticals, for the indication in the approved labeling: treatment of Lambert-Eaton myasthenic syndrome (LEMS). LEMS is a rare autoimmune disorder in which the immune system attacks the connection between nerves and muscles, causing muscle weakness. Firdapse is approved in the United States for adults and pediatric patients 6 years and older.
Lupin is one of the first ANDA applicants for the drug and is therefore eligible for 180 days of shared generic exclusivity, meaning only the earliest filers may sell the generic during that period.
Lupin's announcement did not give a U.S. launch date or price. Contemporary Pediatrics, a pediatrics trade outlet, noted that under an August 2025 patent settlement, Lupin agreed not to market its generic in the United States any earlier than February 25, 2035, unless certain limited circumstances in such agreements occur.
Headquartered in Mumbai, Lupin distributes products in more than 100 markets across generics, complex generics, specialty medicines and biosimilars, with a workforce of more than 26,000 people.
(Source: Lupin company)
Source: Lupin company
Published by GSM · USA (original Chinese edition)
Photo: 制药企业实验室（资料图）。Tokumeigakarinoaoshima 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / A pharmaceutical company laboratory (file photo). Photo by Tokumeigakarinoaoshima, CC BY-SA 4.0, via Wikimedia Commons.
