Lupin gains 180 days of shared generic exclusivity

Lupin received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Amifampridine Tablets. The company is among the first applicants for this drug and qualifies for 180 days of shared generic exclusivity.

The USFDA approved the 10 mg version of the tablets, which the company stated are bioequivalent to the reference listed drug Firdapse Tablets, 10 mg. This reference drug is manufactured by Catalyst Pharmaceuticals, Inc. The approval allows Lupin to market the medication for the indications specified in the approved labeling.

Lupin operates as a transnational pharmaceutical company that develops, produces, and markets a variety of generic and branded formulations. Its portfolio also includes biotechnology products and active pharmaceutical ingredients distributed across global markets. The company maintains these operations to supply its products to customers in various international regions. This latest regulatory clearance adds to the firm’s existing range of pharmaceutical offerings currently available for distribution.

Based on company and agency reports. For information only; not investment advice.