News ArticleLupin Limited Gains U.S. FDA Approval for Amifampridine Tablets and 180-Day Shared Generic Exclusivity
Approval covers 10 mg bioequivalent generic to Firdapse®, positioning Lupin as a first-to-file ANDA applicant eligible for exclusivity period
Lupin Limited has obtained U.S. FDA approval for its 10 mg Amifampridine Tablets, bioequivalent to Catalyst Pharmaceuticals' Firdapse®, granting Lupin eligibility for 180 days of shared generic exclusivity as a first-to-file applicant. This approval marks a significant regulatory milestone for Lupin in the U.S. pharmaceutical market.
Lupin Limited
General / Other
Lupin Limited has received U.S. FDA approval for its Amifampridine Tablets, 10 mg, which are bioequivalent to the reference drug Firdapse® by Catalyst Pharmaceuticals, making Lupin eligible for 180 days of shared generic exclusivity as a first-to-file applicant.
The approval granted by the FDA is for Lupin’s Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg, matching the reference listed drug Firdapse® Tablets, 10 mg, for the approved indication.
As one of the initial ANDA filers, Lupin qualifies for 180 days of shared generic exclusivity in the U.S., which allows them a limited period of market exclusivity for the generic product.
Lupin is a global pharmaceutical company headquartered in Mumbai, India, with a wide presence internationally including in the U.S. and multiple other markets, offering a broad portfolio including generics, specialty medicines, and biosimilars.
This approval marks a significant regulatory achievement for Lupin in the U.S. pharmaceutical sector, potentially enhancing their footprint in a key market.
Highlights
- U.S. FDA approval obtained for Amifampridine Tablets, 10 mg generic formulation.
- Product is bioequivalent to Catalyst Pharmaceuticals’ Firdapse® Tablets, 10 mg.
- Lupin eligible for 180-day shared generic exclusivity as a first-to-file ANDA applicant.
- Approval announced on November 2, 2026.
- Strengthens Lupin's presence in the U.S. pharmaceutical market.
Key Data Snapshot
What happened
- Lupin received U.S. FDA approval for its Amifampridine Tablets, 10 mg, via an Abbreviated New Drug Application (ANDA).
- This product is bioequivalent to the FDA-approved reference drug Firdapse® Tablets, 10 mg, marketed by Catalyst Pharmaceuticals.
- As a first-to-file applicant, Lupin qualifies for a 180-day period of shared generic exclusivity in the U.S. market.
Key details
- The approval enables Lupin to market Amifampridine Tablets in the U.S. for the indication approved in the labeling of Firdapse® Tablets.
- The exclusivity period offers Lupin a temporary competitive advantage by limiting generic competition for 180 days.
- Lupin is a global pharmaceutical company with a presence in over 100 markets and a diverse portfolio including generics and specialty drugs.
Background and context
- Firdapse® is a registered trademark of SERB S.A., the original reference product for Amifampridine Tablets.
- The regulatory approval supports Lupin’s expansion strategy in developed markets, particularly in the U.S.
- The company maintains multiple manufacturing and research facilities supporting its global operations.
Highlights
- U.S. FDA approval obtained for Amifampridine Tablets, 10 mg generic formulation.
- Product is bioequivalent to Catalyst Pharmaceuticals’ Firdapse® Tablets, 10 mg.
- Lupin eligible for 180-day shared generic exclusivity as a first-to-file ANDA applicant.
- Approval announced on November 2, 2026.
- Strengthens Lupin's presence in the U.S. pharmaceutical market.
Disclosures
- Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015
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