Dr Reddy’s Laboratories has announced the launch of Bosutinib Tablets 400 mg in the United States, becoming the first company to introduce a generic version of Bosulif® at this strength. The launch marks a significant addition to the company’s oncology portfolio and reflects its ongoing commitment to improving access to affordable cancer therapies.
The product has been introduced through a collaboration with MSN Laboratories Private Limited, a leading Indian pharmaceutical company. Under the arrangement, MSN is responsible for product development and manufacturing, while Dr Reddy’s holds exclusive marketing rights for the product in the United States.
Bosutinib is used in the treatment of specific forms of leukemia and represents an important therapeutic option for patients requiring targeted oncology treatments. As a first-to-file product, Bosutinib Tablets 400 mg qualifies for 180 days of generic drug exclusivity in the U.S. market, providing Dr Reddy’s with a valuable opportunity to expand its presence in the oncology segment.
Milan Kalawadia, Chief Executive Officer – North America, Dr Reddy’s Laboratories, said the launch demonstrates the company’s commitment to ensuring timely market access to critical therapies while expanding treatment options for healthcare providers and patients. He noted that strengthening the oncology portfolio remains a key strategic priority for the company.
Bharat Reddy, Executive Director of MSN Laboratories, highlighted the successful development and commercialization of the product as evidence of MSN’s capabilities in complex oncology medicines. He emphasized the company’s focus on delivering high-quality pharmaceutical products supported by strong research, regulatory expertise, and advanced manufacturing infrastructure. According to industry sales data, the Bosulif® 400 mg brand recorded U.S. sales of approximately US$253.8 million during the twelve months ending April 2026, indicating substantial market demand for the therapy.
Founded in 1984 and headquartered in Hyderabad, Dr Reddy’s has established a strong global presence across generics, biosimilars, active pharmaceutical ingredients, branded formulations, and over-the-counter products. The company serves major markets including the United States, India, Europe, China, Brazil, and CIS countries.
MSN Laboratories has built a reputation as a research-driven pharmaceutical organization with integrated capabilities spanning APIs and finished dosage formulations. With regulatory-approved facilities in India and the United States, the company supports global healthcare needs through innovation, manufacturing excellence, and affordable medicines
