India Pharma Outlook Team | Monday, 05 October 2026
Aurobindo Pharma’s CNS portfolio is gaining depth as the company secures USFDA approval for generic perampanel tablets, adding another epilepsy treatment to its US pipeline.
Aurobindo received final approval to manufacture and market six strengths of perampanel, equivalent to Catalyst Pharmaceutical’s Fycompa.
The US market for perampanel was estimated at USD 67 million for the 12 months ended August 2026, with Aurobindo planning to launch the drug in Q3 FY27.
The approval takes Aurobindo’s total USFDA Abbreviated New Drug Application (ANDA) approvals to 599, including 574 final approvals, strengthening its position in the generic drug market.
More importantly, the move follows another epilepsy-related approval earlier this year, pointing to a broader CNS drug portfolio strategy rather than a one-off generic launch.
The perampanel approval adds another product to Aurobindo’s growing epilepsy franchise.
The tablets are indicated for partial-onset seizures in patients aged four years and older, and as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged 12 years and older.
The product will be manufactured at Unit-IV of APL Healthcare, Aurobindo’s wholly owned subsidiary. The development follows Aurobindo’s August USFDA approval for eslicarbazepine acetate tablets in four strengths.
That product is an AB-rated generic equivalent of Aptiom, marketed by Sumitomo Pharma America, and is also indicated for partial-onset seizures in patients aged four years and older.
Taken together, the approvals indicate that Aurobindo is adding depth within epilepsy therapies rather than relying on a single CNS product.
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The perampanel approval also highlights the scale of Aurobindo’s US generic drug platform. The company now has 599 USFDA ANDA approvals, comprising 574 final and 25 tentative approvals.
For Aurobindo, the significance is therefore broader than the USD 67 million market attached to perampanel.
A large approved pipeline gives the company multiple opportunities to introduce products across therapeutic categories, while targeted approvals in CNS can build greater portfolio density within specific treatment areas.
Rather than measuring its pipeline only by the number of approvals, the combination of generic portfolio scale and therapeutic-area expansion could become increasingly important as the company brings more products to the US market.
The company’s recent US product activity also includes approvals for brivaracetam oral solution and sacubitril and valsartan, showing that the broader pipeline extends beyond epilepsy.
The next test will be commercial execution. Aurobindo plans to launch generic perampanel in Q3 FY27, allowing it to compete in an established market while leveraging its existing US generic infrastructure.
The USD 67 million market estimate provides a measurable opportunity, but actual uptake will depend on pricing, competition, and the timing of other generic entrants.
The more significant development is the emerging pattern. With perampanel following eslicarbazepine, Aurobindo is building a more concentrated presence in epilepsy treatment while continuing to expand its wider US generic pipeline.
That makes the latest FDA approval less about adding one product and more about how Aurobindo is using its 599-ANDA base to develop therapeutic depth.
If the company continues adding CNS products across formulations and indications, its US strategy could increasingly combine portfolio scale with greater depth in selected therapeutic areas.
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