In a significant boost to their oncology portfolio in the United States, global pharmaceutical major Lupin Limited and its alliance partner Natco Pharma Limited have received approval from the U.S. Food and Drug Administration (FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection.

The approval covers Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials, a generic version of Halaven® Injection, the reference listed drug marketed by Eisai Inc.

Eribulin Mesylate Injection is used in the treatment of adults with metastatic breast cancer who have previously undergone at least two chemotherapy regimens for metastatic disease. The drug is also indicated for patients suffering from unresectable or metastatic liposarcoma who have earlier received an anthracycline-containing treatment regimen.

The FDA approval marks an important milestone for Lupin and Natco as they continue to expand their presence in the oncology segment, a key area of focus in the global pharmaceutical market.

According to IQVIA data for the 12-month period ending April 2026, the reference product Halaven® recorded estimated annual sales of approximately USD 43.7 million in the United States, highlighting the commercial opportunity for the newly approved generic version.

The approval is expected to improve access to a more affordable treatment option for cancer patients while strengthening the companies’ footprint in the highly competitive U.S. generics market.

With the latest regulatory clearance, Lupin and Natco further reinforce their commitment to bringing cost-effective, high-quality medicines to patients worldwide, particularly in complex therapeutic areas such as oncology.