Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Extended-Release Tablets USP, available in 200 mg, 250 mg, and 300 mg dosages. This approval allows Alembic to market a generic version of GlaxoSmithKline's Lamictal XR, a medication used in the treatment of certain seizure disorders.
This approval marks a significant step for Alembic Pharmaceuticals in expanding its portfolio of generic medications. The drug aims to provide a more accessible and cost-effective alternative for patients requiring lamotrigine extended-release tablets.
Therapeutic Equivalence and Indications
The approved ANDA is therapeutically equivalent to Lamictal XR, ensuring that it provides the same clinical benefits as the brand-name drug. Lamotrigine extended-release tablets are indicated for:
- Adjunctive therapy for primary generalized tonic-clonic seizures in patients aged 13 years and older.
- Adjunctive therapy for partial-onset seizures, with or without secondary generalization, in patients aged 13 years and older.
- Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are already receiving treatment with a single antiepileptic drug.
Market Size and Alembic's Portfolio
According to IQVIA data, the market size for Lamotrigine Extended-Release Tablets USP is estimated at $163 million for the twelve-month period ending in June 2024. This approval adds to Alembic's growing list of ANDA approvals, which now totals 216 (188 final and 28 tentative) from the US FDA.
Analyst Perspectives
In the previous month, HSBC upgraded Alembic Pharmaceuticals shares to 'hold,' increasing the target price from Rs 1,010 to Rs 1,130 per share. The brokerage noted that Alembic's enhanced US regulatory filings and expanding portfolio of differentiated products could bolster long-term US sales growth. However, they emphasized that strong execution remains critical for Alembic to realize substantial gains in U.S. sales.
