Alembic Bags USFDA Approval for USD 27 Million Lamotrigine ODT Market
New Delhi: Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Orally Disintegrating Tablets USP in strengths of 25 mg, 50 mg, 100 mg and 200 mg, the company informed the stock exchanges on February 26, 2026.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Lamictal ODT Orally Disintegrating Tablets of GlaxoSmithKline LLC.
Lamotrigine is indicated as adjunctive therapy in patients aged two years and above for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures, and generalized seizures associated with Lennox-Gastaut syndrome. It is also approved for conversion to monotherapy in adults aged 16 years and older with partial-onset seizures who are being treated with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as a single antiepileptic drug.
Additionally, lamotrigine is indicated for maintenance treatment of bipolar I disorder to delay the recurrence of mood episodes in patients previously treated for acute mood episodes with standard therapy. The company has advised referring to the product label for detailed indications.
According to IQVIA data, Lamotrigine Orally Disintegrating Tablets USP, across the approved strengths, recorded an estimated market size of approximately US$27 million for the twelve months ending December 2025.
With this latest clearance, Alembic now holds a cumulative total of 235 ANDA approvals from the USFDA, including 216 final approvals and 19 tentative approvals.
Headquartered in Vadodara, Alembic Pharmaceuticals Limited is a vertically integrated research and development-driven pharmaceutical company that has been engaged in healthcare since 1907. The publicly listed firm manufactures and markets generic pharmaceutical products globally, with research and manufacturing facilities approved by several international regulatory authorities, including the USFDA. The company is also among the leaders in India’s branded generics segment, supported by a field force of over 5,500 representatives.
