Key Quantitative Figures and Product Details
The company announced the first-to-market launch of Bosutinib Tablets 400mg in the United States on June 13, 2026. This product is a generic equivalent of Bosulif®. The branded product, Bosulif®, had U.S. sales of approximately $253.8 million for the latest 12-month period ended April 2026, according to IQVIA National Sales Perspectives data.
Parties Involved and Collaboration Terms
Dr. Reddy's has collaborated with MSN Laboratories Private Limited (MSN) on this product. MSN is responsible for the development and manufacturing of Bosutinib Tablets. Dr. Reddy's holds the exclusive marketing rights for the product in the United States.
Regulatory and Market Status
The launched product was a first-to-file product and is therefore eligible for 180 days of generic drug exclusivity for the 400mg strength in the U.S. market.
Management Commentary
Milan Kalawadia, CEO- North America, Dr. Reddy's Laboratories, Inc. stated that the launch highlights the company's commitment to timely market entry for high-priority therapies and broadening access to affordable treatments. He noted it strengthens the company's oncology portfolio.
Bharat Reddy, Executive Director, MSN Laboratories commented that the launch demonstrates MSN's capabilities in complex oncology products and its commitment to delivering high-quality, affordable medicines globally.
Trademark Information
The disclosure notes that Bosulif® is a registered trademark of Wyeth LLC.