Regulatory Approval Details

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules, 25 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc.

Product Indication

Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: a) have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, b) are metastatic or where surgical resection is likely to result in severe morbidity, and c) have no satisfactory alternative treatments or that have progressed following treatment.

Market Exclusivity Status

Based on the most recent update to the FDA's online Paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Larotrectinib Capsules (25 mg and 100 mg), containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S.

Market Size

Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of US$ 91 million for twelve months ending March 2026 according to IQVIA.

Company ANDA Approval History

Alembic has a cumulative total of 241 ANDA approvals (221 final approvals and 20 tentative approvals) from USFDA.

Company Background

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been operating since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products worldwide. The company's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India with brands marketed through a field force of over 5500.