Hyderabad's Aurobindo Pharma Gets USFDA Nod for Epilepsy Drug Perampanel
The generic version of Fycompa will be made at APL Healthcare's Unit-IV and targets a US market estimated at $67 million.
Hyderabad-based Aurobindo Pharma has received final approval from the US Food and 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 product is bioequivalent to Fycompa Tablets, the reference listed drug marketed by Catalyst Pharmaceuticals.
Use and market
Perampanel is used to treat partial-onset seizures in epilepsy patients aged four years and above, and as an add-on therapy for primary generalised tonic-clonic seizures in patients aged 12 and above.
Citing IQVIA data for the 12 months to August 2026, the company said the approved product has an estimated US market size of about $67 million.
Launch timeline
The tablets will be manufactured at Unit-IV of APL Healthcare, an Aurobindo subsidiary, and the company plans to launch them in the US in the third quarter of FY2026-27.
With this approval, Aurobindo's tally of USFDA ANDA approvals reaches 599 — 574 final and 25 tentative. The company sells its products in more than 150 countries.
Source: Medical Dialogues
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