Alembic Pharma gets tentative USFDA nod for generic cancer drug; may secure 180-day exclusivity

Alembic Pharmaceuticals Ltd. received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of Larotrectinib Capsules in strengths of 25 mg and 100 mg, the company said in an exchange filing on Thursday, June 11.

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to Bayer Healthcare Pharmaceuticals' Vitrakvi Capsules, a kinase inhibitor used to treat certain adult and pediatric patients with solid tumours that carry a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

Larotrectinib is prescribed for patients whose cancers are metastatic or cannot be safely removed through surgery, and who either have no satisfactory alternative treatment options or whose disease has progressed despite prior treatment.

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Alembic Pharma said it is the first applicant to have filed an ANDA for Larotrectinib Capsules with a Paragraph IV certification under the Hatch-Waxman Act. Subject to final approval from the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the United States.

According to IQVIA data cited by the company, Larotrectinib Capsules recorded estimated annual sales of $91 million in the US for the 12 months ended March 2026.

Last week, the pharma company received final USFDA approval for its generic version of Haloperidol Tablets, used for the treatment of psychotic disorders and for the control of tics and vocal utterances associated with Tourette's Disorder in both children and adults.

With the latest approval, Alembic Pharma's cumulative USFDA tally stands at 241 ANDA approvals, comprising 221 final approvals and 20 tentative approvals.

Shares of Alembic Pharma are now trading 0.8% higher on Thursday at ₹743.5. The stock is down 6% in the last one month and down around 12% for the year so far.