Product Approval Details
Aurobindo Pharma Limited received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets in six dosage strengths: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. The tablets are bioequivalent and therapeutically equivalent to the reference listed drug Fycompa® Tablets of Catalyst Pharmaceuticals, Inc.
Manufacturing and Launch Plans
The product will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary of the Company. The launch is scheduled for Q3 FY27 (October-December 2026 quarter).
Market Size and ANDA Portfolio
The approved product has an estimated market size of US$ 67 million for the twelve months ending August 2026, according to IQVIA MAT data. With this approval, Aurobindo Pharma now has a total of 599 ANDA approvals from USFDA, consisting of 574 final approvals and 25 tentative approvals.
Therapeutic Indications
Perampanel Tablets are indicated for:
- Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older
- Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older
Company Background
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India that develops, manufactures, and commercializes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients in over 150 countries. The company operates 30+ manufacturing and packaging facilities approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. Their product portfolio spans seven major therapeutic areas: CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.