By: IPP Bureau
Last updated : October 04, 2026 9:40 am
The product will be manufactured at Unit-IV of APL Healthcare
Aurobindo Pharma Limited has secured final approval from the US Food & Drug Administration (USFDA) to manufacture and market its generic Perampanel Tablets.
The approval covers six dosage strengths—2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg—which have been established as bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fycompa Tablets, held by Catalyst Pharmaceuticals, Inc.
The product will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary of the company and will be launched in Q3FY27.
The approved product has an estimated market size of US$ 67 million for the twelve months ending August 2026, according to IQVIA MAT. Aurobindo Pharma now has a total of 599 ANDA approvals (574 final approvals and 25 tentative approvals) from USFDA.
Perampanel Tablets are (i) indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older and (ii) indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.