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Dr. Reddy's launches bosutinib, generic of Bosulif

As a first-to-file product, bosutinib is eligible for 180 days of generic drug exclusivity for this strength, in the U.S.

PRINCETON, N.J. — Dr. Reddy’s Laboratories has rolled out bosutinib tablets 400mg, a generic equivalent of Wyeth's Bosulif.

The first to market launch expands Dr. Reddy's oncology portfolio, reinforcing its commitment to improving patient access to affordable, high-quality medicines.

Dr. Reddy’s has collaborated with MSN Laboratories Private Ltd., a leading pharmaceutical company in India, on bosutinib. Dr. Reddy’s holds the exclusive marketing rights in the U.S. MSN is responsible for development and manufacturing.

As a first-to-file product, bosutinib is eligible for 180 days of generic drug exclusivity for this strength, in the U.S.

“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, Dr. Reddy's North America CEO. "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.”

Bharat Reddy, executive director of MSN, added, “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.”

Bosulif (400mg) had U.S. sales of approximately $253.8 million for the year ended in April, according to IQVIA.

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