Alembic Pharmaceuticals Limited (Alembic) has received final approval from the U.S. 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 approved product is therapeutically equivalent to the reference listed drug (RLD), Lamictal ODT Orally Disintegrating Tablets, marketed by GlaxoSmithKline LLC. With this approval, Alembic can market the generic version in the United States.
Lamotrigine is widely prescribed as an anti-epileptic and mood-stabilizing medication. It is indicated as adjunctive therapy in patients aged 2 years and older for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures, and generalized seizures associated with Lennox-Gastaut syndrome. The drug is also approved for conversion to monotherapy in adults aged 16 years and older with partial-onset seizures who are currently on other single antiepileptic drugs such as carbamazepine, phenytoin, phenobarbital, primidone, or valproate.
In addition to epilepsy treatment, Lamotrigine is indicated for the maintenance treatment of bipolar I disorder. It helps delay the time to occurrence of mood episodes in patients who have been treated for acute mood episodes with standard therapy. Patients and healthcare providers are advised to refer to the prescribing label for detailed indications and usage guidelines.
According to IQVIA data for the twelve months ending December 2025, the estimated market size for Lamotrigine Orally Disintegrating Tablets in the United States stands at approximately US$ 27 million. The approval provides Alembic an opportunity to strengthen its presence in the US generics market within the central nervous system (CNS) therapeutic segment.
With this latest approval, Alembic has received a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals. The development reflects the company’s continued focus on expanding its regulated market portfolio, particularly in the United States.