Alembic Pharmaceuticals Limited received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules in 25 mg and 100 mg strengths. The regulatory milestone was announced through a press release on June 11, 2026.
The ANDA is therapeutically equivalent to the reference listed drug Vitrakvi Capsules of Bayer Healthcare Pharmaceuticals Inc. Larotrectinib is a kinase inhibitor indicated for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. The indication covers patients with metastatic disease or cases where surgical resection is likely to result in severe morbidity, and applies when no satisfactory alternative treatments exist or the disease has progressed following prior therapy.
Alembic is the sole first applicant to file its ANDA for Larotrectinib Capsules with a Paragraph IV certification under the Hatch-Waxman Act. Upon final USFDA approval, Alembic may be eligible for 180 days of generic marketing exclusivity in the US market, restricting other generic entrants during that period.
Larotrectinib Capsules had an estimated US market size of US$ 91 million for the twelve months ending March 2026, according to IQVIA data. The product addresses a niche oncology segment targeting tumors with NTRK gene fusions.
Alembic holds cumulative ANDA approvals totaling 241 from USFDA. This includes 221 final approvals and 20 tentative approvals across Alembic's generic product portfolio.
Alembic's USFDA-approved manufacturing facilities support its growing ANDA pipeline for the US generic pharmaceutical market.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.