Lupin氨吡啶片获FDA批准：Firdapse仿制药治罕见肌无力综合征，享180天共享独占期
制药公司Lupin Limited 11月2日在印度孟买与美国佛罗里达州Naples宣布，美国食品药品监督管理局（FDA）已批准其氨吡啶片10毫克的简略新药申请（ANDA）。
该仿制药与Catalyst Pharmaceuticals公司的原研药Firdapse（氨吡啶片10毫克）生物等效，适应症以获批标签为准，即用于治疗兰伯特-伊顿肌无力综合征（LEMS）。LEMS是一种罕见的自身免疫性疾病，患者自身免疫系统攻击神经与肌肉之间的连接处，导致肌肉无力。Firdapse在美国获批用于成人及6岁以上儿童患者。
Lupin是最早提交该药ANDA的厂商之一，因此有资格获得180天的共享仿制药独占期，即在独占期内只有最早提交申请的几家厂商可以销售该仿制药。
Lupin在公告中没有说明这款仿制药在美国的上市时间与售价。儿科行业媒体Contemporary Pediatrics指出，根据2025年8月的一项专利和解，Lupin同意不早于2035年2月25日在美国市场销售该仿制药，除非出现和解协议中约定的有限情形。
Lupin总部位于印度孟买，产品销往100多个市场，在美国、印度及其他市场经营仿制药、复杂仿制药、专科药与生物类似药，全球员工超过26,000人。
（来源：Lupin）
Lupin Wins FDA Approval for Amifampridine Tablets: a Firdapse Generic for a Rare Muscle-Weakness Disorder, With 180 Days of Shared Exclusivity
Lupin Limited announced on November 2, in Mumbai, India, and Naples, Florida, that the U.S. Food and Drug Administration has approved its abbreviated new drug application (ANDA) for amifampridine tablets, 10 mg.
The generic is bioequivalent to the reference listed drug, Firdapse tablets, 10 mg, from Catalyst Pharmaceuticals, for the indication in the approved labeling: treatment of Lambert-Eaton myasthenic syndrome (LEMS). LEMS is a rare autoimmune disorder in which the immune system attacks the connection between nerves and muscles, causing muscle weakness. Firdapse is approved in the United States for adults and pediatric patients 6 years and older.
Lupin is one of the first ANDA applicants for the drug and is therefore eligible for 180 days of shared generic exclusivity, meaning only the earliest filers may sell the generic during that period.
Lupin's announcement did not give a U.S. launch date or price. Contemporary Pediatrics, a pediatrics trade outlet, noted that under an August 2025 patent settlement, Lupin agreed not to market its generic in the United States any earlier than February 25, 2035, unless certain limited circumstances in such agreements occur.
Headquartered in Mumbai, Lupin distributes products in more than 100 markets across generics, complex generics, specialty medicines and biosimilars, with a workforce of more than 26,000 people.
(Source: Lupin company)
来源：Lupin
发布：GSM·美国（发布链接）
图片来源：制药企业实验室（资料图）。Tokumeigakarinoaoshima 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / A pharmaceutical company laboratory (file photo). Photo by Tokumeigakarinoaoshima, CC BY-SA 4.0, via Wikimedia Commons.
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