Alembic Pharmaceuticals has secured final approval from the US Food & Drug Administration (USFDA) for its Fingolimod Capsules, 0.5 mg. The drug, which is a therapeutic equivalent to the reference product Gilenya, is indicated for treating relapsing forms of multiple sclerosis. According to IQVIA, the estimated market size for this product in the US reached US$ 145 million for the twelve months ending December 2025.
Strategic Portfolio Expansion
The company has announced a significant milestone with the receipt of USFDA final approval for Fingolimod Capsules, 0.5 mg. This medication is a sphingosine 1-phosphate receptor modulator, prescribed for patients aged 10 and older suffering from relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Market Opportunity and Regulatory Standing
The approval marks a strategic addition to Alembic’s generic product portfolio. Industry data from IQVIA indicates that Fingolimod Capsules 0.5 mg represent a substantial market opportunity, with annual sales estimated at US$ 145 million for the period ending December 2025. This approval underscores the company’s commitment to expanding its global footprint in the specialty pharmaceutical segment.
Cumulative Approval Milestone
With this latest authorization, Alembic Pharmaceuticals has reached a cumulative total of 237 ANDA approvals from the USFDA. This figure comprises 219 final approvals and 18 tentative approvals, reflecting the company’s strong research and manufacturing capabilities in delivering high-quality, affordable generic medicines to international markets.
Source: BSE
