Lupin Expands US Portfolio with USFDA Approval for Amifampridine

17 Mar 2025 , 10:28 PM

The United States Food and Drug Administration (USFDA) has issued a tentative approval for Lupin Ltd’s Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg. The approval allows Lupin to enter the market for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune neuromuscular disorder affecting communication between nerve and muscle.

Lupin said the tablets would be made at its Goa facility, which would bolster its global manufacturing capabilities and continued dedication to delivering affordable medications. This represents a large market opportunity for Lupin’s generic, as reference drug Firdapse had global net sales of $306 million for the fiscal year ended December 31, 2024.

Although tentative approval means that Lupin’s application satisfies all quality, safety and efficacy requirements, final approval of the product will be dependent on the expiration of or resolution of patent or exclusivity rights related to Firdapse. This approval is in line with Lupin’s focus on developing and expanding its presence in the US market.