Lupin 获美国 FDA 批准 Amifampridine 片剂，为首仿申请者享 180 天共享仿制药独占期
Lupin Receives U.S. FDA Approval for Amifampridine Tablets
Lupin 获得美国 FDA 对 Amifampridine 片剂 10 mg 简化新药申请（ANDA）的批准，该产品与 Catalyst Pharmaceuticals 的 Firdapse 片剂 10 mg 生物等效。Lupin 是首批 ANDA 申请者之一，有资格获得 180 天共享仿制药独占期。
As the First-To-File, Lupin is Eligible for 180-Day Shared Generic Exclusivity
MUMBAI, India and NAPLES, Fla., /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Amifampridine Tablets, 10 mg.
Amifampridine Tablets, 10 mg, are bioequivalent to the reference listed drug (RLD), Firdapse® Tablets, 10 mg, of Catalyst Pharmaceuticals, Inc., for the indication in the approved labeling. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. Lupin has a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, and continues to strengthen its market position through a differentiated portfolio. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. 15 state-of-the-art manufacturing facilities support sustainable operations, with 6 research centers and a dedicated workforce of over 26,000 professionals. Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company's business strategy.
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
Firdapse® is the registered trademark of SERB S.A.
SOURCE Lupin Pharmaceuticals, Inc.
来源：PR Newswire Health · prnewswire.com