Dr. Reddy’s launches generic Bosulif in the US, secures 180-day exclusivity
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Dr. Reddy’s Laboratories on Friday announced the launch of Bosutinib Tablets 400 mg in the US, becoming the first generic player to enter the market with a version of Bosulif, a treatment used for certain forms of chronic myeloid leukaemia (CML).
The Hyderabad-based drugmaker said the product is a first-to-file generic and is eligible for 180 days of market exclusivity in the U.S.
The launch comes through a collaboration with MSN Laboratories. Under the arrangement, Dr Reddy’s holds exclusive marketing rights for the product in the U.S., while MSN is responsible for development and manufacturing.
Bosulif, originally developed by Pfizer , is used for the treatment of Philadelphia chromosome-positive chronic myeloid leukaemia, a type of blood cancer.
According to IQVIA National Sales Perspectives data cited by the company, the branded Bosulif 400 mg recorded sales of approximately $253.8 million in the U.S. during the 12 months ended April 2026.
Collaboration with MSN Laboratories
“This launch highlights our commitment to leading with timely market entry for high-priority therapies while broadening access for both patients and healthcare providers,” said Milan Kalawadia, CEO, North America, Dr. Reddy’s Laboratories Inc.
“With this launch, we remain focussed on strengthening our oncology portfolio and partnering across the healthcare system to ensure that critical treatments are both accessible and affordable,” he added.
Bharat Reddy, executive director of MSN Laboratories, said the launch demonstrates the company’s development, regulatory and manufacturing capabilities in oncology products.
“The successful development and commercialization of Bosutinib Tablets demonstrates MSN’s strong scientific, regulatory and manufacturing capabilities in complex oncology products,” he said.
Dr. Reddy’s said Bosutinib Tablets 400 mg is a generic equivalent of Bosulif and that the launch expands its oncology portfolio in the U.S. market. The company added that MSN developed and manufactures the product, while Dr. Reddy’s is responsible for commercialisation in the United States.
Bosutinib Tablets 400 mg was a first-to-file product and is eligible for 180 days of generic drug exclusivity for the strength in the U.S., the company said.