Hyderabad-based Aurobindo Pharma has expanded its oncology portfolio with the launch of a generic version of a cancer drug in the United States through its subsidiary Eugia Pharma Specialities Ltd, strengthening its presence in the global generics market.
The company said the product has received final approval from the U.S. Food and Drug Administration (USFDA), allowing the firm to manufacture and market the generic drug in the US. The medicine is a generic equivalent of the branded therapy Sprycel, originally developed by Bristol Myers Squibb, and is used to treat certain forms of blood and bone-marrow cancers.
According to the company, the approved product includes multiple dosage strengths and has been found bioequivalent and therapeutically equivalent to the reference listed drug.
Targeting treatment for blood and bone-marrow cancers
The generic medicine Dasatinib tablets is indicated for treating patients with specific types of leukaemia and other blood-related cancers. The treatment works by blocking abnormal proteins that cause cancer cells to grow and multiply.
The approval enables the company to market tablets in several strengths, including 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg, expanding treatment options for oncologists and patients in the United States.
The product is expected to be launched in the US market in the coming financial period, the company said in a regulatory filing.
Significant commercial opportunity in the US market
Industry data suggests that the drug represents a substantial commercial opportunity.
According to IQVIA market data cited by the company, the reference drug recorded estimated annual sales of about $1.8 billion in the United States for the 12-month period ending February 2025.
By introducing a generic alternative, Aurobindo Pharma aims to capture a share of this high-value oncology market while also expanding patient access to more affordable treatments.
Strengthening India’s global generics footprint
The development reflects the continued expansion of Indian pharmaceutical companies in regulated global markets, particularly the United States, which remains the world’s largest market for generic medicines.
Founded in 1986 and headquartered in Hyderabad, Aurobindo Pharma manufactures generic medicines and active pharmaceutical ingredients and exports products to more than 125 countries, with a significant share of its revenues coming from international markets.
The company has been steadily strengthening its oncology pipeline as global demand grows for more affordable cancer therapies, particularly after the expiry of patents on several blockbuster drugs.
Rising focus on oncology generics
The launch underscores a broader industry trend in which Indian drugmakers are expanding into complex generics and oncology therapies.
As patents for several high-value cancer drugs expire, pharmaceutical companies are increasingly developing generic equivalents to meet growing global demand while reducing treatment costs for patients.
For Aurobindo Pharma, the latest launch adds to its oncology portfolio and reinforces its strategy of building a stronger presence in specialised therapeutic segments within the global generics market.