Glenmark, Alembic receive USFDA approval for LacosamideGLENMARK - 400 Change: -3.85 (-0.95 %)
News: Glenmark Pharma and Alembic Pharma have received USFDA final approval for its ANDA for Lacosamide tablets, USP 50 mg, 100 mg, 150 mg and 200 mg (generic for Vimpat Tablets of UCB). Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older. Lacosamide tablets have an estimated market size of ~ US$1.67 billion (MAT December 2021, IQVIA).
Views: Vimpat (Lacosamide) was accessed by over 8,00,000 people living with epilepsy, showed strong growth in all regions for UCB and lost US exclusivity in March, 2022. Lacosamide presents a blockbuster generic opportunity in the US amid loss of exclusivity. With multiple players lined up for this drug, final USFDA approval for both Alembic and Glenmark bodes well for gaining market share. We expect the incremental contribution from approved drug from Q1FY23 to offset some pressure on base business of both Glenmark and Alembic Pharma