Alembic Pharmaceuticals announced that it has secured the USFDA Final Approval 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. This generic product is therapeutically equivalent to GlaxoSmithKline’s reference listed drug, Lamictal ODT. The market for these tablets is estimated at US$ 27 million annually, providing a strong commercial opportunity for Alembic.
USFDA Final Approval Secured for Key Generic Drug
Alembic Pharmaceuticals Limited confirmed on 26th February, 2026, that it has received the Final Approval from the US Food & Drug Administration (USFDA) for its Lamotrigine Orally Disintegrating Tablets USP. The approved strengths cover 25 mg, 50 mg, 100 mg, and 200 mg.
This approval pertains to the Abbreviated New Drug Application (ANDA) submitted by Alembic. The product is therapeutically equivalent to the reference listed drug (RLD), Lamictal ODT Orally Disintegrating Tablets, originally manufactured by GlaxoSmithKline LLC.
Therapeutic Indications and Market Potential
Lamotrigine is an important anti-epileptic drug (AED) indicated for use as adjunctive therapy in patients aged 2 years and older for managing various seizure types, including partial-onset seizures and seizures associated with Lennox-Gastaut syndrome. It is also indicated for the maintenance treatment of bipolar I disorder to delay mood episode recurrence.
The estimated market size for the Lamotrigine Orally Disintegrating Tablets (all strengths combined) is significant, valued at approximately US$ 27 million for the twelve months ending December 2025, according to IQVIA data.
Company Milestones
This latest approval contributes to Alembic’s growing pipeline of products in the US market. The company stated that it now has a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is highlighted as a vertically integrated research and development pharmaceutical company operating since 1907. The company manufactures and markets generic pharmaceutical products globally, leveraging state-of-the-art research and manufacturing facilities that are approved by major international regulatory bodies, including the USFDA. Alembic maintains a significant presence in India’s branded generics market through a field force exceeding 5,500 personnel.
Source: BSE
