Lupin receives US FDA approval for amifampridine tablets 10 mg

Lupin Ltd has received US Food and Drug Administration (FDA) approval for its generic version of amifampridine tablets, 10 mg. The company disclosed the approval to the exchanges on November 2, 2026, in a press release it filed under the SEBI listing rules. The Lupin FDA approval covers abbreviated new drug applications (ANDAs) for the tablet, which Lupin says is bioequivalent to the reference product, Firdapse 10 mg tablets, made by Catalyst Pharmaceuticals.

Lupin FDA approval: what was approved

An ANDA is the route US regulators use for generic drugs. It relies on the original product’s safety and efficacy data and asks the regulator to confirm that the generic delivers the same amount of active ingredient into the body in the same way. Lupin says its tablet meets that bioequivalence test against Firdapse 10 mg, for the indication in the approved labelling.

The release does not state the price, the launch date or the expected sales from the product. Those details are not in the filing.

First-to-file and 180-day exclusivity

Lupin says it is one of the first ANDA applicants for this product and is eligible for 180 days of shared generic exclusivity. In the US, the first company or companies to file a valid generic application for a drug can receive a period in which the FDA does not approve other generic versions. When several first filers share that period, each may sell the generic during it. The 180-day window is therefore a period with limited generic competition, but the release does not say how many companies share it.

About Lupin

The company describes itself as a global pharmaceutical company headquartered in Mumbai, with products sold in over 100 markets. Its release says it has 15 manufacturing facilities, six research centres and more than 26,000 employees. It also says it has strong positions in the US and India across cardiovascular, respiratory, diabetes, gastrointestinal and women’s health therapies.

Why this matters for investors and readers

The approval adds a product to Lupin’s US generic range, which is one of the company’s main markets. The next step would be the launch, which the company has not announced in the release.

What to watch next

Watch for the launch announcement and for any change to the list of companies that share the exclusivity period. Lupin’s quarterly results will show whether approvals like this translate into US sales. For more coverage, see more deals news.