Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fingolimod Capsules, 0.5 mg.
The approved drug is a therapeutically equivalent generic version of Gilenya Capsules, 0.5 mg, originally marketed by Novartis Pharmaceuticals Corporation. Fingolimod is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients aged 10 years and older.
According to IQVIA data, Fingolimod Capsules, 0.5 mg, have an estimated market size of approximately $145 million in the United States for the twelve months ending December 2025, presenting a meaningful opportunity for Alembic in the US generics segment.
With this approval, Alembic has now received a cumulative total of 237 ANDA approvals from the USFDA, comprising 219 final approvals and 18 tentative approvals. The development further strengthens the company’s presence in the regulated US market and expands its portfolio in the central nervous system (CNS) therapeutic segment.
Headquartered in Vadodara, Alembic Pharmaceuticals is a vertically integrated research and development-driven company engaged in manufacturing and marketing generic pharmaceutical products globally. The company continues to focus on expanding its pipeline and strengthening its position in key international markets.
Disclaimer: This article is based solely on the information provided and is for informational purposes only. It does not constitute investment advice.