Alembic Pharma Moves Closer to Potential 180-Day US Market Exclusivity with Cancer Drug Approval

Alembic Pharmaceuticals Ltd. ($APLLTD) has received tentative approval from the USFDA for its generic version of Larotrectinib Capsules in 25 mg and 100 mg strengths, a drug used to treat certain adult and pediatric patients with solid tumours carrying NTRK gene fusion. The medicine is prescribed for cancers that are metastatic, cannot be safely removed through surgery, or have progressed despite existing treatments. Alembic stated that it was the first company to file an ANDA for this product with a Paragraph IV certification, positioning it for a potential 180-day generic marketing exclusivity period in the US, subject to final regulatory approval. The reference product, Vitrakvi, recorded estimated annual US sales of approximately $91 million during the 12 months ended March 2026, highlighting the market opportunity. The development follows the company's recent final USFDA approval for generic Haloperidol Tablets, used in the treatment of psychotic disorders and Tourette's Disorder. With this latest milestone, Alembic Pharma's cumulative USFDA approval count has reached 241 ANDAs, including 221 final approvals and 20 tentative approvals, reflecting the company's continued focus on expanding its presence in the regulated US pharmaceutical market. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.