Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) to market Lamotrigine Extended-Release Tablets USP in 200 mg, 250 mg, and 300 mg strengths.

The product is a generic equivalent of GlaxoSmithKline’s Lamictal XR extended-release tablets and is indicated for:

• Adjunctive therapy for primary generalised tonic-clonic seizures and partial-onset seizures (with or without secondary generalisation) in patients aged 13 years and above.

• Conversion to monotherapy in patients aged 13 years and above with partial-onset seizures currently on a single antiepileptic drug.

According to IQVIA data, the US market for Lamotrigine Extended-Release Tablets in these strengths is estimated at USD 163 million for the 12 months ending June 2024.

This approval adds to Alembic Pharma’s growing US generics portfolio, taking its cumulative Abbreviated New Drug Application (ANDA) approvals from the USFDA to 216.

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For pharma industry stakeholders, this development highlights Alembic’s continued focus on expanding its neurology therapeutic segment in the US generics market, where complex extended-release formulations present significant market entry barriers but also high-value opportunities.

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