Global pharmaceutical giant Lupin Ltd. on Monday announced a significant milestone in its expansion strategy within the US market, securing tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg.This approval positions Lupin to tap into a substantial market opportunity for a drug indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune neuromuscular disorder, the company said in a filing.
The Amifampridine Tablets will be manufactured at Lupin’s state-of-the-art facility in Goa.
This strategic move leverages Lupin’s established manufacturing capabilities and its commitment to providing affordable and accessible medications, the company said.The market for Amifampridine Tablets, specifically Firdapse, recorded an estimated global net sale of $306 million for the fiscal year ending December 31, 2024, highlighting the significant potential for Lupin’s generic version.
The Amifampridine Tablets will be manufactured at Lupin’s state-of-the-art facility in Goa.
This strategic move leverages Lupin’s established manufacturing capabilities and its commitment to providing affordable and accessible medications, the company said.The market for Amifampridine Tablets, specifically Firdapse, recorded an estimated global net sale of $306 million for the fiscal year ending December 31, 2024, highlighting the significant potential for Lupin’s generic version.
“The tentative approval signifies that Lupin’s application has met all required quality, safety, and efficacy standards, although final approval depends on the expiration or resolution of patent or exclusivity issues related to the reference drug, Firdapse,” it said.
With a strong presence in key therapeutic areas such as respiratory, cardiovascular, and central nervous system disorders, the addition of Amifampridine Tablets further strengthens Lupin’s portfolio and its commitment to improving patient outcomes.
Shares of Lupin Ltd. are currently trading 1.55% higher on Monday at Rs 1,999.
