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Dr Reddy’s hits US with generic Bosutinib for CML, gets 180-day exclusivity

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  • June 13, 2026
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Dr Reddy’s hits US with generic Bosutinib for CML, gets 180-day exclusivity

Dr Reddy’s Laboratories has launched Bosutinib Tablets 400mg in the US, a generic version of Pfizer’s Bosulif used to treat Chronic Myeloid Leukaemia. The Hyderabad-based firm announced the first-to-market launch on Friday.

The drug is indicated for adults with Philadelphia chromosome-positive CML, including newly-diagnosed cases and patients resistant or intolerant to prior therapy. Dr Reddy’s holds exclusive US marketing rights, while partner MSN Laboratories handled development and manufacturing.

Bosutinib 400mg was a first-to-file product and gets 180 days of generic exclusivity. Bosulif 400mg clocked US sales of about $253.8 million in the 12 months ended April 2026, as per IQVIA data.

“This launch highlights our commitment to timely entry for high-priority therapies and broadening patient access,” said Milan Kalawadia, CEO-North America, Dr Reddy’s. Bharat Reddy of MSN Labs added that the launch shows their capabilities in complex oncology products.

The move strengthens Dr Reddy’s oncology portfolio as it pushes affordable cancer medicines. The stock slipped 0.09% to ₹1,272.90 on Friday.