Lupin Limited, a global pharmaceutical company headquartered in Mumbai, India, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg. The approval represents an addition to the company’s generic pharmaceutical portfolio in the U.S. market and provides an opportunity to expand access to an established treatment option.
According to the company’s announcement dated November 2, 2026, Lupin’s Amifampridine Tablets, 10 mg, have been determined to be bioequivalent to the reference-listed drug (RLD), Firdapse® Tablets, 10 mg, marketed by Catalyst Pharmaceuticals, Inc. The product is approved for the indication specified in the reference product’s approved labeling. Lupin has also confirmed that it is among the first applicants to receive approval for the ANDA and is eligible for 180 days of shared generic drug exclusivity.
Amifampridine is a potassium channel blocker used in the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and, according to the approved Firdapse labeling, in pediatric patients aged six years and older. LEMS is a rare autoimmune neuromuscular disorder characterized by impaired communication between nerves and muscles, resulting in muscle weakness and reduced physical function. The condition is associated with antibodies targeting presynaptic voltage-gated calcium channels, which interfere with acetylcholine release at the neuromuscular junction.
Amifampridine works by blocking voltage-gated potassium channels in nerve terminals, prolonging the action potential and increasing calcium influx. This enhances the release of acetylcholine, thereby improving neuromuscular transmission and muscle strength. The 180-day shared generic exclusivity eligibility is a significant commercial aspect of Lupin’s approval. Such exclusivity provides qualifying first applicants with a defined period of generic market exclusivity under applicable U.S. regulatory provisions, supporting their position during the initial phase of generic competition.
The approval further strengthens Lupin’s presence in the U.S. generics market and expands its portfolio of pharmaceutical products. With operations spanning more than 100 markets, the company continues to focus on generics, complex generics, specialty medicines and biosimilars. Overall, the USFDA approval marks an important regulatory and commercial milestone for Lupin, adding Amifampridine Tablets to its approved product portfolio while positioning the company among the early entrants in the U.S. generic market for this therapy.
Link: https://www.lupin.com/media/press-releases/lupin-receives-u-s-fda-approval-for-amifampridine-tablets
