Dr. Reddy's Announces First-to-Market Launch of Bosutinib Tablets 400mg in the U.S.

Dr. Reddy's Announces First-to-Market Launch of Bosutinib Tablets 400mg in the U.S.

Dr. Reddy's Announces First-to-Market Launch of Bosutinib Tablets 400mg in the U.S.​

Dr. Reddy's Laboratories Ltd. has announced the first-to-market launch of Bosutinib Tablets 400mg, a generic equivalent of Bosulif®, in the United States. The product launch, confirmed on June 13, 2026, reinforces Dr. Reddy's commitment to expanding its oncology portfolio and improving patient access to affordable medicines.

The launch is the result of a collaboration between Dr. Reddy's Laboratories Ltd. and MSN Laboratories Private Limited (MSN), a pharmaceutical company based in India. While 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.

Bosutinib Tablets 400mg is classified as an Oncology medication—a generic equivalent of the established drug Bosulif®. As a first-to-file product, the tablet strength is eligible for 180 days of generic drug exclusivity in the U.S. market.

The launch underscores both companies' commitment to strategic growth in the complex oncology sector. Milan Kalawadia, CEO - North America at Dr. Reddy's Laboratories, stated that this launch highlights their dedication to timely market entry for high-priority therapies. He added that the move strengthens the company's oncology portfolio and ensures critical treatments are accessible and affordable across the healthcare system.

Bharat Reddy, Executive Director of MSN Laboratories, commented on the successful commercialization. He noted that the development of Bosutinib Tablets demonstrates MSN's strong scientific, regulatory, and manufacturing capabilities in complex oncology products, maintaining a commitment to delivering high-quality, affordable medicines globally.

The market context for the original drug, Bosulif®, which is a registered trademark of Wyeth LLC, shows considerable performance. According to IQVIA National Sales Perspectives data, the U.S. sales of Bosulif® (400mg) were approximately $253.8 million during the latest 12-month period ended April 2026.

DRREDDY Stock Price Movement​

On Friday, shares of Dr. Reddy's Laboratories Limited slipped by 0.24% to settle at ₹1275.40. The equity saw a traded volume amounting to approximately 1.65 million shares during the session.
 

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