A view of Dr. Reddy’s Laboratories in Hyderabad.
Dr. Reddy’s Laboratories announced on Saturday (June 13, 2026 ) the first-to-market launch of Bosutinib Tablets 400 mg, a generic equivalent of Pfizer subsidiary Wyeth’s cancer drug Bosulif, in the U.S.
Bosutinib Tablets (400mg) was a first-to-file product and thus eligible for 180-days of generic drug exclusivity for this strength, in the U.S., Dr. Reddy’s said.
For the product, it had collaborated with another Hyderabad-based generic drugmaker MSN Laboratories. While the exclusive marketing rights for the product in the U.S. rest with Dr. Reddy’s, MSN is responsible for the development and manufacturing of the product, the company said.
The Bosulif brand (400 mg) had U.S. sales of approximately $253.8 million for the latest 12-month period ended April 2026, it said, citing IQVIA National Sales Perspectives data.
“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,” CEO- North America of Dr. Reddy’s Milan Kalawadia said.
The successful development and commercialisation of Bosutinib Tablets demonstrates MSN’s strong scientific, regulatory, and manufacturing capabilities in complex oncology products, said Bharat Reddy, Executive Director of MSN Laboratories.
According to the U.S. FDA, Bosulif is a kinase inhibitor indicated for the treatment of adult patients with newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML); and chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.
Published – June 13, 2026 04:19 pm IST
