Alembic Pharma receives USFDA tentative approval for generic Larotrectinib capsules
Drug targets NTRK fusion-positive solid tumors; company may gain 180-day marketing exclusivity in the US
With this development, Alembic's cumulative USFDA approvals have reached 241, comprising 221 final approvals and 20 tentative approvals.
Mumbai: Alembic Pharmaceuticals Limited has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules in 25 mg and 100 mg strengths, the company announced on Thursday.
The approved ANDA is therapeutically equivalent to Bayer Healthcare Pharmaceuticals Inc.’s reference listed drug, Vitrakvi Capsules, available in the same strengths.
Larotrectinib is a kinase inhibitor used in the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, are metastatic or unsuitable for surgery without significant morbidity, and have no satisfactory alternative treatment options or have progressed following treatment.
According to the company, it is the sole first applicant to have filed an ANDA for Larotrectinib Capsules with a Paragraph IV certification under the Hatch-Waxman Act. Upon receiving final approval from the USFDA, Alembic may become eligible for 180 days of generic marketing exclusivity in the United States.
The company said Larotrectinib Capsules had an estimated market size of US$91 million for the 12 months ending March 2026, based on IQVIA data.
With this development, Alembic’s cumulative USFDA approvals have reached 241, comprising 221 final approvals and 20 tentative approvals.
Headquartered in India, Alembic Pharmaceuticals is a vertically integrated pharmaceutical company engaged in research, development, manufacturing and marketing of generic medicines globally. The company has been operating in the healthcare sector since 1907 and maintains manufacturing and research facilities approved by regulatory authorities in several developed markets, including the USFDA.
About Alembic Pharmaceuticals
Alembic Pharmaceuticals Limited is a publicly listed pharmaceutical company engaged in the development, manufacturing and marketing of generic pharmaceutical products worldwide. The company is among the leading players in India’s branded generics market and markets its products through a field force of more than 5,500 professionals.
