Mumbai: Aurobindo Pharma announced on October 3, 2026, that it has received final approval from the USFDA to manufacture and market Perampanel Tablets in 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths. These tablets are bioequivalent and therapeutically equivalent to Fycompa® Tablets from Catalyst Pharmaceuticals, Inc.
Market Opportunity
The estimated market size for Perampanel Tablets stood at US$ 67 million (approximately ₹558 crore) for the twelve months ending August 2026, according to IQVIA MAT data. Aurobindo Pharma now holds a total of 599 ANDA approvals from the USFDA.
Product Launch and Manufacturing
The Perampanel Tablets will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary of Aurobindo Pharma. The company plans to launch the product in the third quarter of fiscal year 2027.
Therapeutic Indications
Perampanel Tablets are indicated for the treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients aged 4 years and older. They are also approved as adjunctive therapy for primary generalised tonic-clonic seizures in patients aged 12 years and older.
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