Alembic receives USFDA tentative approval for Larotrectinib Capsules ANDA
Company becomes sole first applicant for generic Larotrectinib Capsules with Paragraph IV certification
Alembic Pharmaceuticals has announced that it has received tentative approval from the US Food and 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 (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc.
Larotrectinib is a kinase inhibitor indicated for the treatment of adult and paediatric patients with solid tumours that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment. The company advised referring to the product label for the complete indication.
According to the most recent update to the USFDA’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 Hatch-Waxman Act.
The company stated that upon final approval of the ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the United States.
According to IQVIA data for the twelve months ending March 2026, Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of US$91 million.
With this development, Alembic has a cumulative total of 241 ANDA approvals from the USFDA, comprising 221 final approvals and 20 tentative approvals.