USFDA final approval received for Perampanel Tablets in 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg

USFDA final approval for Perampanel Tablets in 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.

Sat 3 Oct 2026

Approval Type

USFDA final approval for Perampanel Tablets

Strengths Approved

2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg

Market Size (IQVIA MAT)

US$ 67 million for 12 months ending August 2026

Manufacturing Location

APL Healthcare Unit-IV

Total ANDA Approvals

599 (574 final + 25 tentative)

USFDA final approval for Perampanel Tablets

The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets in six strengths: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.

The approved tablets 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 will be launched in Q3FY27.

What the medicine is used 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.

Market size and approval tally

• The approved product has an estimated market size of US$ 67 million for the twelve months ending August 2026, according to IQVIA MAT.
• With this approval, the company's total USFDA ANDA approvals are 599, made up of 574 final approvals and 25 tentative approvals.

How to read this

An ANDA, or Abbreviated New Drug Application, is the US regulatory route for a generic version of a medicine that is already approved. A final approval means the company can manufacture and market that generic in the US market.

The US$ 67 million market size figure describes the size of the opportunity as measured by IQVIA MAT for the twelve months ending August 2026. It is a measure of the existing market for the product, not a projection of the company's own sales from it.

The update states the launch is planned in Q3FY27, so any commercial supply from this product would follow that launch, subject to market conditions, competition and pricing in the US generics segment.

About the company's manufacturing base

Aurobindo Pharma has 30+ manufacturing and packaging facilities approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC and Brazil ANVISA, and sells across over 150 countries, with a product portfolio spread over seven major therapeutic areas.

What this adds

• A new final approval widens the US generic product portfolio.
• The product is a bioequivalent and therapeutically equivalent version of an existing listed drug, which is the basis for a generic launch in the US.
• The approval count of 599 gives a sense of the scale of the company's cumulative US updates cleared by the regulator, of which 25 remain tentative at this point.

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