The approved tablets are bioequivalent and therapeutically equivalent to the reference listed drug Fycompa tablets of Catalyst Pharmaceuticals, Inc.
The product will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma, and will be launched in Q3 FY27.
The approved product has an estimated US market size of $67 million for the 12 months ended August 2026, according to IQVIA MAT.
With this approval, Aurobindo Pharma now has a total of 599 ANDA approvals from the USFDA, comprising 574 final approvals and 25 tentative approvals.
Perampanel tablets are indicated for the treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 4 years and older.
They are also indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
Earlier on October 1, in a separate development, Aurobindo Pharma launched Adquey, its first novel drug in the US market.Adquey, originally discovered by Otsuka Pharmaceutical and licensed to Aurobindo’s arm Acrotech for US commercialisation, is a non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor used to treat mild-to-moderate atopic dermatitis in adults and children aged two years and above.
The drug has patent protection until 2036. The US market for the product category was estimated at around $1.3 billion for the 12 months ended July 2026, according to IQVIA MAT.
The launch also marks Acrotech’s entry into the US dermatology market. The company has established a dedicated dermatology business unit with commercial capabilities across marketing, sales and field engagement to support Adquey and build its presence in the segment.
Aurobindo Pharma shares closed 0.34% lower at ₹1,666.30 on October 1 at NSE.
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