Alembic Pharmaceuticals has received tentative approval from the U.S. 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 Vitrakvi (Larotrectinib) Capsules, 25 mg and 100 mg, marketed by Bayer Healthcare Pharmaceuticals.

Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that harbor a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. 

The therapy is intended for patients with metastatic disease or tumors where surgical resection is likely to result in severe morbidity, and who either have no satisfactory alternative treatment options or whose disease has progressed following treatment.

According to the latest update in the FDA’s online Paragraph IV database, Alembic is the sole first applicant to have submitted an ANDA for Larotrectinib Capsules (25 mg and 100 mg) containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act.

As a result, upon receiving final approval from the USFDA, Alembic may become eligible for 180 days of generic marketing exclusivity in the United States, providing a significant commercial advantage before additional generic competitors enter the market.

Larotrectinib Capsules, 25 mg and 100 mg, represent an estimated U.S. market opportunity of approximately US$ 91 million for the twelve-month period ending March 2026, according to IQVIA data.

The tentative approval further strengthens Alembic’s growing U.S. generics portfolio. With this addition, the company has accumulated a total of 241 ANDA approvals from the USFDA, comprising 221 final approvals and 20 tentative approvals.

The development underscores Alembic’s continued focus on expanding its oncology and specialty pharmaceutical portfolio in regulated markets while leveraging complex generic opportunities with limited competition.