Overview

• Alembic’s ANDA covers Doxorubicin Hydrochloride Liposome injection in 20 mg/10 mL and 50 mg/25 mL single-dose vials for ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myeloma.
• The approved generic is deemed therapeutically equivalent to Baxter Healthcare’s liposomal doxorubicin formulation.
• IQVIA estimates the US market for liposomal doxorubicin at $29 million for the year ending March 2025.
• Shares of Alembic Pharmaceuticals jumped more than 12% to a near six-month high following the FDA approval announcement.
• The latest nod brings Alembic’s cumulative USFDA ANDA tally to 224, including 201 final approvals and 23 tentative approvals.