Dr Reddy's Laboratories Ltd. has announced the launch of Bosutinib Tablets 400mg, marking the first generic version of Pfizer's Bosulif to enter the US market. According to the latest exchange filing, the Hyderabad-based pharmaceutical company holds exclusive marketing rights for the product in the United States, while MSN Laboratories Private Limited is responsible for development and manufacturing. The product is specifically designed to treat adults with Ph+ Chronic Myeloid Leukaemia (CML). As per Business Standard, the company has secured 180 days of generic drug exclusivity for the 400mg strength, positioning it as a first-to-file (FTF) product in the US market. Milan Kalawadia, DRL CEO for North America, emphasized that the launch reflects the company's focus on bringing important therapies to market quickly while improving affordability and access for patients and healthcare providers.
The launch targets a significant market opportunity, as Pfizer's Bosulif had US sales of approximately $253.8 million for the latest 12-month period ending in April 2026. According to IQVIA National Sales Perspectives data, this represents a substantial addressable market for the generic version. The global CML treatment market is estimated to be over $9 billion in 2025, with the US being a major market that sees 9,000 to 9,500 new cases of the rare cancer every year. The 180-day exclusivity period provides the first generic entrant with a temporary period of limited competition, potentially supporting market share gains and strengthening Dr Reddy's oncology portfolio.
The product launch represents a collaboration between Dr Reddy's and MSN Laboratories Private Limited. According to Business Standard, as part of the collaboration, DRL will hold the exclusive marketing rights for the product in the US, while MSN will be responsible for the development and manufacturing of the product. While DRL has not commented on the pricing, a 400mg dosage form of Pfizer's Bosulif is listed at a wholesale cost of about $21,495 to $21,740 for a bottle of 30 tablets in the US. Bharat Reddy, Executive Director at MSN Laboratories, said the launch highlights the company's capabilities in developing, manufacturing and commercialising complex oncology products, while reinforcing its commitment to supplying affordable medicines globally.
The company's stock performance showed mixed results following the announcement. DRL shares ended Friday's session 0.24% lower at ₹1,272.90, as reported by CNBC TV18. However, the stock has demonstrated positive momentum this year with a rise of around 2% so far in 2026. The 52-week high mark stands at ₹1,379.70 per share, indicating the stock's recent performance relative to its annual high. Shares of Dr Reddy's are expected to remain in focus on Monday, June 15, as investors assess the impact of this strategic oncology portfolio expansion.
