Pharmaceutical company Lupin, in partnership with Natco Pharma, has received approval from the United States Food and Drug Administration (USFDA) for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials.

The approved product is a generic version of Halaven (eribulin mesylate injection), marketed by Eisai Inc., and has been found to be bioequivalent to the reference listed drug. The approval enables the companies to market the oncology therapy in the United States, further strengthening their presence in the global generic pharmaceuticals market.

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 approved for patients with unresectable or metastatic liposarcoma who have previously received an anthracycline-containing treatment regimen.

The approval represents an important addition to the oncology portfolios of both companies, providing patients with access to a lower-cost alternative to the branded therapy. According to IQVIA data for the moving annual total ending April 2026, Halaven recorded estimated annual sales of approximately USD 43.7 million in the United States, highlighting the market opportunity for the generic product.

Lupin, headquartered in Mumbai, is one of India’s leading pharmaceutical companies with a strong presence in both domestic and international markets. The company operates across several therapeutic segments, including respiratory care, cardiovascular diseases, diabetes, anti-infectives, gastroenterology, central nervous system disorders and women’s health. Lupin currently operates 15 manufacturing facilities and seven research centres worldwide, supported by a workforce of more than 24,000 employees. The company has also expanded into diagnostics, digital health and pharmaceutical manufacturing services through its subsidiary businesses.

Natco Pharma, based in Hyderabad, is engaged in the development, manufacturing and marketing of generic and branded medicines, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The company operates nine manufacturing facilities and two research and development centres across India.

The latest USFDA approval reinforces the ongoing collaboration between Lupin and Natco and reflects their continued focus on expanding access to high-quality, affordable medicines for patients worldwide. The launch of generic Eribulin Mesylate Injection is expected to contribute to greater treatment accessibility for patients battling advanced cancers while strengthening the companies’ oncology offerings in the US market.