Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Orally Disintegrating Tablets USP in four dosage strengths. The company announced this regulatory milestone, which expands its portfolio in the specialized neurological therapeutics segment.

Product Specifications and Approval Details

The approved ANDA covers Lamotrigine Orally Disintegrating Tablets USP in 25 mg, 50 mg, 100 mg and 200 mg strengths. The approved product is therapeutically equivalent to the reference listed drug product (RLD), Lamictal ODT Orally Disintegrating Tablets of GlaxoSmithKline LLC.

Therapeutic Applications

Lamotrigine 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 of Lennox-Gastaut syndrome. The medication is also approved for conversion to monotherapy in adults aged 16 years and older with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

Additionally, Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.

Market Opportunity and Strategic Impact

According to IQVIA data, Lamotrigine Orally Disintegrating Tablets USP have an estimated market size of $27.00 million for the twelve months ending December 2025. The orally disintegrating tablet format addresses specific patient needs, particularly for individuals with swallowing difficulties or those requiring discrete medication administration.

With this latest approval, Alembic Pharmaceuticals now holds a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals. This achievement strengthens the company's position in the competitive US generics market and demonstrates its capability in developing complex pharmaceutical formulations for neurological and psychiatric treatments.

Alembic Pharmaceuticals has achieved a significant regulatory milestone with the United States Food and Drug Administration (USFDA) granting final approval for its Efinaconazole Topical Solution, 10%. The company announced this development through an official press release and regulatory filing, marking an important expansion of its product portfolio in the US pharmaceutical market.

Product Details and Market Equivalence

The approved Efinaconazole Topical Solution, 10% serves as a generic equivalent to Jublia Topical Solution, 10%, manufactured by Bausch Health Americas, Inc. This regulatory clearance enables Alembic Pharmaceuticals to manufacture and market the topical solution across the United States. The solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Regulatory Achievement and Market Position

Alembic was one of the first ANDA applicants to submit a substantially complete Abbreviated New Drug Application with a paragraph IV certification for this product. The Efinaconazole Topical Solution, 10%, has an estimated market size of US$ 500 million for twelve months ending December 2025 according to IQVIA data.

Company's USFDA Portfolio Expansion

With this latest approval, Alembic Pharmaceuticals now holds a cumulative total of 234 ANDA approvals from the USFDA. This portfolio comprises 215 final approvals and 19 tentative approvals, demonstrating the company's consistent regulatory success in the US market.

Strategic Significance

The USFDA approval represents a key achievement in Alembic Pharmaceuticals' strategy to expand its presence in the US generics market. By securing approval for a product equivalent to an established brand like Jublia, the company positions itself to capture market share in the antifungal topical treatment category. This regulatory success demonstrates the company's capability to develop and gain approval for complex topical formulations, potentially opening doors for similar product developments in the future.