Lupin Limited and its alliance partner Natco Pharma Limited have received approval from the United States Food and Drug Administration (US FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials. The approval expands the companies’ oncology portfolio in the United States and strengthens their presence in the market for complex injectable medicines.
The approved product is the bioequivalent version of Halaven® Injection, originally developed and marketed by Eisai, Inc. Eribulin Mesylate Injection is indicated for the treatment of adults with metastatic breast cancer who have previously undergone at least two chemotherapy regimens for metastatic disease. It is also indicated for patients with unresectable or metastatic liposarcoma who have received prior treatment with an anthracycline-containing regimen.
The approval represents another step in the ongoing efforts of Lupin and Natco to increase access to affordable treatment options for patients requiring advanced cancer therapies. Generic oncology products play a critical role in healthcare systems by expanding treatment availability while helping manage healthcare costs.
According to industry sales data, the reference product recorded annual US sales of approximately USD 43.7 million during the twelve months ending April 2026. The approval provides both companies with an opportunity to participate in an established therapeutic segment while offering healthcare providers and patients an additional treatment option.
The collaboration between Lupin and Natco combines expertise in pharmaceutical development, regulatory affairs, manufacturing, and commercialization. Over the years, both companies have worked together on complex generic products that require specialized formulation capabilities and rigorous regulatory compliance.
Lupin continues to maintain a significant global presence across branded and generic pharmaceuticals, biotechnology products, active pharmaceutical ingredients, and specialty medicines. Headquartered in Mumbai, the company markets its products in more than 100 countries and has built strong positions across multiple therapeutic categories, including respiratory care, cardiovascular medicine, diabetes management, anti-infectives, gastroenterology, central nervous system disorders, and women’s health.
Supported by an extensive manufacturing and research network, Lupin operates multiple production facilities and research centers worldwide. The company’s activities also extend into diagnostics, digital health solutions, and pharmaceutical manufacturing services through its specialized business divisions.
