Lupin Shares in Focus; Introduces Dasatinib Tablets to the US Market

Lupin Limited has notified stock exchanges of the launch of Dasatinib Tablets in the United States following approval from the US Food and Drug Administration. 

Developed in collaboration with Pharmascience Inc., the product marks an addition to Lupin’s oncology offerings in a key global market and aligns with the company’s focus on complex generics.

Regulatory Disclosure to Stock Exchanges

On February 2, 2026, Lupin Limited made a disclosure under Regulation 30 of the SEBI Listing Regulations, informing the National Stock Exchange of India and BSE Limited about the launch of Dasatinib Tablets in the US. 

The disclosure was accompanied by an official press release for public dissemination.

Product Launch and FDA Approval

The launch follows the approval of Lupin’s Abbreviated New Drug Application by the US FDA. Dasatinib Tablets have been introduced in multiple strengths ranging from 20 mg to 140 mg and were developed in partnership with Pharmascience Inc., a Canada-based pharmaceutical manufacturer.

Therapeutic Indications

Dasatinib Tablets are bioequivalent to Sprycel® by Bristol-Myers Squibb Company. The product is indicated for the treatment of Philadelphia chromosome-positive chronic myeloid leukaemia across various disease phases, as well as Philadelphia chromosome-positive acute lymphoblastic leukaemia. 

Approved use includes both adult patients and paediatric patients aged one year and above, subject to specific clinical conditions.

Market Context

According to industry data, the reference listed drug Sprycel® recorded estimated annual sales of approximately USD 930 million in the United States for the twelve months ended October 2025. This provides context to the size of the therapeutic segment in which Lupin’s product has been launched.

Collaboration with Pharmascience

The product was developed jointly with Pharmascience Inc., which has a global presence and supplies medicines to over 50 countries. 

The collaboration combines Lupin’s experience in complex generics with Pharmascience’s manufacturing and international distribution capabilities.

Overview of Lupin Limited

Lupin Limited is a Mumbai-headquartered pharmaceutical company with operations spanning more than 100 markets. Its portfolio includes branded and generic formulations, biotechnology products and active pharmaceutical ingredients, supported by a global manufacturing and research footprint.

Lupin’s share Price Performance

On February 2, 2026, Lupin’s shares were trading at ₹2,130.40, reflecting a marginal decline from the previous close. During the trading session, the stock moved between a low of ₹2,078.20 and a high of ₹2,148.00.

Read More: Union Budget 2026 Highlights: Your 5-Minute Guide to Fiscal, Tax and Sectoral Measures.

Conclusion

The launch of Dasatinib Tablets in the United States represents a regulatory and commercial milestone for Lupin within the oncology segment. While market impact will depend on competitive and pricing dynamics, the development underscores the company’s continued engagement in regulated global markets through partnerships and complex generic offerings.

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