Alembic Pharmaceuticals receives USFDA final approval for Fingolimod Capsules 0.5 mg, a generic for multiple sclerosis treatment, targeting a $145 million U.S. market.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Fingolimod Capsules, 0.5 mg, marking another addition to its U.S. generics portfolio.
The approval covers the company’s Abbreviated New Drug Application (ANDA) and confirms that the product is therapeutically equivalent to the reference listed drug, Gilenya (fingolimod) by Novartis Pharmaceuticals Corporation.
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients aged 10 years and older.
According to IQVIA data, the U.S. market for Fingolimod Capsules, 0.5 mg, was valued at approximately $145 million for the 12 months ending December 2025.
With this approval, Alembic’s cumulative tally of USFDA ANDA approvals has reached 237, comprising 219 final approvals and 18 tentative approvals.
Alembic Pharmaceuticals, headquartered in India, is a vertically integrated pharmaceutical company with a focus on research, development, and manufacturing of generic medicines. The company operates globally and maintains regulatory-compliant facilities approved by multiple international authorities, including the USFDA.
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About the Writer
Sana Jamil Khan is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.
