Alembic Pharmaceuticals Limited has 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. This approval is therapeutically equivalent to Vitrakvi Capsules. The company is the sole first applicant for this ANDA, potentially earning 180 days of generic marketing exclusivity in the U.S. The estimated market size for these capsules is US$91 million.
USFDA Tentative Approval Received
Alembic Pharmaceuticals Limited announced on June 11, 2026, that it has received tentative approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules, in both 25 mg and 100 mg strengths. This approval signifies a significant milestone for the company in the U.S. market.
Product and Indication
The approved ANDA for Larotrectinib Capsules is therapeutically equivalent to the reference listed drug product, Vitrakvi Capsules, 25 mg and 100 mg, manufactured by Bayer Healthcare Pharmaceuticals Inc. Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that possess a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. It is particularly relevant for metastatic tumors or those where surgical resection may lead to severe morbidity, and for patients with no satisfactory alternative treatments or who have progressed following other therapies.
Market Exclusivity and Size
Alembic Pharmaceuticals is noted as the sole first applicant to have filed its ANDA for Larotrectinib Capsules, containing a Paragraph IV certification. This position potentially makes the company eligible for 180 days of generic marketing exclusivity in the U.S. market upon final approval of the ANDA. According to IQVIA data, the estimated market size for Larotrectinib Capsules (25 mg and 100 mg) was approximately US$91 million for the twelve months ending March 2026.
Company Achievements
This tentative approval adds to Alembic’s growing portfolio of USFDA approvals. The company has a cumulative total of 241 ANDA approvals from the USFDA, comprising 221 final approvals and 20 tentative approvals.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a history dating back to 1907. Headquartered in India, Alembic is a publicly listed company engaged in manufacturing and marketing generic pharmaceutical products globally. The company’s state-of-the-art research and manufacturing facilities are approved by regulatory authorities in many developed countries. Alembic is recognized as a leader in branded generics within India, with its brands widely adopted by healthcare professionals and patients.
Source: BSE
