Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets in multiple dosage strengths. According to the company's regulatory filing, the approved tablets include 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg dosages, which are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fycompa Tablets, of Catalyst Pharmaceuticals, Inc. The product will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary of the company, and is scheduled for launch in Q3FY27. Data from IQVIA's MAT for the 12 months ended August 2026 estimates the US market size for the approved product at around $67 million, indicating significant commercial potential in the generic epilepsy drug segment.
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. This approval adds to Aurobindo Pharma's growing portfolio of US market-ready products, with the company now holding a total of 599 ANDA approvals (574 final approvals and 25 tentative approvals) from USFDA. The company's total number of ANDA approvals has risen to 599 with this latest addition.
In the previous trading session, Aurobindo Pharma shares closed at ₹1,675, up ₹8.50 or 0.51 percent. The stock has demonstrated strong performance with a 52-week high of ₹1,739.60 and a 52-week low of ₹1,066.00, achieved on 24 September 2026 and 08 October 2025 respectively. Currently, the stock is trading 3.71 percent below its 52-week high and 57.13 percent above its 52-week low. The company's market capitalisation stands at ₹97,284.27 crore.
In September, Acrotech Biopharma Inc, a step-down subsidiary of Aurobindo Pharma, announced the US launch of ADQUEY (difamilast 1%) ointment, a non-steroidal topical treatment for mild-to-moderate atopic dermatitis in adults and pediatric patients 2 years of age and older. This latest approval for Perampanel tablets represents another significant addition to the company's US pharmaceutical portfolio, with the US market estimated at $67 million providing substantial commercial opportunities.
