Dr Reddy’s Laboratories has announced the first-to-market US launch of Bosutinib tablets 400mg, a generic equivalent of Bosulif.

 

The launch marks a strategic expansion of its oncology portfolio and a push to widen access to lower-cost cancer therapies.

 

The company said the product strengthens its position in high-value oncology generics and reinforces its broader goal of improving access to affordable medicines in the United States. 

 

Dr Reddy’s has partnered with MSN Laboratories on the product, with Dr Reddy’s holding exclusive US marketing rights while MSN leads development and manufacturing.

 

Bosutinib 400mg was a first-to-file product and qualifies for 180 days of generic exclusivity in the U.S., giving it a temporary competitive edge in the market.

 

Milan Kalawadia, CEO – North America, Dr Reddy’s Laboratories, Inc., said: "This launch highlights our commitment to leading with timely market entry for high-priority therapies while broadening access for both patients and healthcare providers. With this launch, we remain focused on strengthening our oncology portfolio and partnering across the healthcare system to ensure that critical treatments are both accessible and affordable.”

 

MSN Laboratories emphasized its role in enabling the launch through its development and manufacturing capabilities.

 

Bharat Reddy, Executive Director, MSN Laboratories, said: “The successful development and commercialization of Bosutinib Tablets demonstrates MSN’s strong scientific, regulatory, and manufacturing capabilities in complex oncology products. We remain committed to delivering high-quality, affordable medicines globally through efficient development and reliable manufacturing excellence.”

 

The launch targets a market where the branded version, Bosulif, generated approximately $253.8 million in US sales over the 12 months ending April 2026, according to IQVIA National Sales Perspectives data.