India Pharma Outlook Team | Friday, 27 February 2026
Alembic Pharma has received final approval from the US Food and Drug Administration (USFDA) for its generic version of Lamotrigine Orally Disintegrating Tablets, marking another step forward in its U.S. expansion strategy. The USFDA approval allows the company to market the drug in strengths of 25 mg, 50 mg, 100 mg, and 200 mg.
The product is therapeutically equivalent to Lamictal ODT by GlaxoSmithKline and is used to treat certain types of seizures.
It is prescribed for epilepsy in patients aged two years and older, including those with Lennox-Gastaut syndrome and primary generalized tonic-clonic seizures. Orally disintegrating tablets are designed to dissolve on the tongue, making them easier to take, especially for children and patients who have difficulty swallowing.
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According to industry data, the approved strengths of Lamotrigine ODT have an estimated market size of about $27 million annually in the United States. With this USFDA approval, Alembic Pharma strengthens its presence in the competitive U.S. generics market, which remains a key revenue driver for Indian drugmakers.
The company has built a strong pipeline of abbreviated new drug applications (ANDAs) and continues to focus on expanding its portfolio across key therapeutic segments. The latest clearance adds to its growing list of approvals from the U.S. regulator and supports its long-term strategy of scaling up operations in regulated markets.
