FDA approves Lupin’s 10 mg amifampridine tablets; company cites 180 days of shared exclusivity

The U.S. Food and Drug Administration approved Lupin Limited’s abbreviated applications for amifampridine tablets at the 10 mg strength, the company announced.³ That is the specific product and strength identified in reports of the approval; the announcement does not describe approval of other strengths.²³ Lupin’s statement says the tablets are bioequivalent to Firdapse® Tablets, 10 mg, the named reference product made by Catalyst Pharmaceuticals, Inc.¹³ The company’s bioequivalence claim is limited to the indication appearing in the product’s approved labeling.³ In a separately labeled assessment, the available information supports describing this as approval of a generic application for a 10 mg product that Lupin says is bioequivalent to the reference drug.³

The news release was dated Nov. 2, 2026, and issued from Mumbai, India, and Naples, Florida.³ Its stated distribution time was 09:45 ET on Nov. 02, 2026, providing a more precise time marker than the date alone.³ Those details identify when and from where the company’s announcement was issued; they do not add a separate approval date beyond what the release reports.³ The reports identify Lupin Limited as headquartered in Mumbai, India, a corporate location distinct from the release’s two issuing locations.¹³

Lupin characterized itself in the release as one of the first applicants to file an abbreviated new drug application.³ The release headline used the designation “First-To-File,” while the body’s wording described the company as one among the first ANDA applicants.³ The company also said it is eligible for 180 days of shared generic exclusivity, a stated period associated with its filing position.²³ A supported reading links the first-to-file designation with eligibility for shared exclusivity, but the release does not identify any other party that may share it.³ Accordingly, the 180-day figure describes the eligibility Lupin reports, not a count of applicants or a stated allocation among them.²³

The product comparison is with Firdapse® Tablets at the same 10 mg strength, rather than with a differently named or differently dosed reference in the supplied facts.¹²³ Lupin’s bioequivalence statement concerns the indication in the approved labeling, so its stated scope is tied to that indication.³ The available information does not provide a numerical measure of bioequivalence, nor does it give comparative clinical results.¹³ It therefore establishes the company’s stated relationship between its tablet and the named reference product, within the indication-specific scope described in the release.¹³

The approval concerns Lupin’s application, while the exclusivity statement concerns the company’s reported eligibility; these are related announcements but distinct claims.²³ The release identifies the applications as abbreviated new drug applications, and the approved dosage form is a tablet containing 10 mg amifampridine.²³ It names Catalyst Pharmaceuticals, Inc. as the maker of the reference listed drug, Firdapse® Tablets, 10 mg.³ Firdapse® is a registered trademark of SERB S.A., a separate detail about the product name used in the comparison.³

The announcement presents Lupin as a company operating across India, the United States, other developed markets, and emerging markets.³ Lupin says its products reach over 100 markets, a company-reported distribution footprint rather than a count of markets for this tablet alone.³ Its described portfolio includes generics, complex generics, specialty medicines, and biosimilars, placing the amifampridine product within a broader set of product categories.³ The release does not state how many of those markets will receive this product or when distribution might occur.³

Lupin says it has leadership in the United States and India across cardiovascular, respiratory, diabetes, gastrointestinal, and women’s health areas.³ That description concerns the company’s stated position in those therapeutic areas; the supplied facts do not connect this particular approval to any of them.³ The company reports that 15 manufacturing facilities support its operations and that it runs 6 research centers.³ Those figures describe facilities and centers across its operations, rather than a stated manufacturing site or research center devoted specifically to amifampridine.³

Lupin reports a workforce of over 26,000 professionals, another company-wide measure presented alongside its facilities and research centers.³ The company says it is extending its healthcare activities through diagnostics, digital health, patient-support programs, and disease-management initiatives.³ The release gives no figures for the reach or scale of those initiatives, and does not say that they are part of this product approval.³ Together, these details describe the broader organization Lupin presents in the release, while the regulatory action itself remains specific to the 10 mg tablets.²³

The announcement’s central change is the FDA’s approval of Lupin’s abbreviated applications for the 10 mg amifampridine tablets.²³ The company pairs that approval with a claim of bioequivalence to the 10 mg Firdapse® reference for the labeled indication, and with reported eligibility for 180 days of shared exclusivity.¹²³ The supplied information establishes those claims and their stated scope, but does not identify other exclusivity participants or provide a product-distribution timetable.²³ The scale of the wider company is given through its reported market reach, portfolio, workforce, facilities, and research centers, not through an estimate of this approval’s commercial effect.³