Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated February 26, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg".
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Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Lamotrigine Orally Disintegrating Tablets in four strengths (25 mg, 50 mg, 100 mg, and 200 mg). The product is therapeutically equivalent to GlaxoSmithKline's Lamictal ODT and is used to treat epilepsy (various seizure types) and bipolar I disorder. The estimated US market size for this product is about US$ 27 million (twelve months ending December 2025, per IQVIA). With this approval, Alembic's cumulative ANDA count from USFDA rises to 235 (216 final approvals and 19 tentative approvals), reinforcing its strong US generics pipeline.
This is a positive development for shareholders as it adds another revenue-generating product in the lucrative US generics market, though the US$ 27 million market size is relatively modest and competitive pressure may limit Alembic's share of it.