Aurobindo Pharma announced on October 3, 2026, that it had received final approval from the US Food and Drug Administration to manufacture and market Perampanel tablets in six strengths, according to its BSE filing. The company plans to launch the product in Q3FY27.

The approval covers 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets. Aurobindo said these are bioequivalent and therapeutically equivalent to the corresponding strengths of Fycompa tablets, the reference listed drug of Catalyst Pharmaceuticals, Inc.

The product will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma. The filing identifies this facility as the manufacturing location for the approved tablets.

Market estimate and approval portfolio

The approved product has an estimated market size of US$67 million for the twelve months ended August 2026, according to IQVIA MAT data cited in the release. This figure represents the product's estimated market size, rather than revenue reported by Aurobindo from the approval.

Following the approval, Aurobindo Pharma said its total USFDA abbreviated new drug application (ANDA) approvals stood at 599. The total comprises 574 final approvals and 25 tentative approvals.

Approved epilepsy indications

The release lists two indications for Perampanel tablets, with different patient age thresholds:

  • Treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged four years and older.
  • Adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.

Headquartered in Hyderabad, Aurobindo Pharma develops, manufactures and commercialises generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients in more than 150 countries. The company said it has over 30 manufacturing and packaging facilities.

Its portfolio spans seven therapeutic or product areas, including central nervous system treatments, antiretrovirals, cardiovascular medicines, antibiotics, gastroenterological products, antidiabetics and antiallergics.

The release includes a forward-looking statement disclaimer covering product uses, sales potential and target launch dates. It states that risks, uncertainties and other factors could cause actual developments and results to differ materially from the company's expectations.