Lupin Launches Dasatinib Tablets in US; Drug Marketed Against $930 Million Sprycel Sales

Pharma major Lupin Limited on Monday announced the launch of Dasatinib Tablets in the United States after receiving approval from the US Food and Drug Administration (USFDA). The product has been developed in partnership with Pharmascience Inc.

Details of the US launch

Lupin has launched Dasatinib Tablets in multiple strengths, including 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The tablets are bioequivalent to Sprycel®, a branded drug sold by Bristol-Myers Squibb.

The approval was granted under Lupin’s Abbreviated New Drug Application (ANDA), allowing the company to market the generic version in the US.

Therapeutic use and patient coverage

Dasatinib is used to treat patients with Philadelphia chromosome-positive (Ph+) blood cancers. The drug is indicated for adults with chronic myeloid leukemia (CML) across various stages and for those who have not responded well to earlier treatments such as imatinib.

It is also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. In addition, the medicine can be used for children aged one year and above, including newly diagnosed cases of Ph+ CML and Ph+ ALL when used along with chemotherapy.

Market opportunity in the US

According to IQVIA data, Sprycel®—the reference listed drug—recorded annual sales of around $930 million in the US for the 12 months ended October 2025. The launch strengthens Lupin’s presence in the high-value oncology generics market.

About Lupin

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, with operations in over 100 countries. The company has a strong footprint in India and the US, offering branded and generic medicines, complex generics, biotech products, and APIs.

Lupin operates 15 manufacturing plants and 7 research centres worldwide, supported by a workforce of more than 24,000 employees.

Read More: India’s Cotton Imports Surge 158% YoY in December Quarter Amid Duty-Free Import.

Lupin Share Price Movement

Lupin share price (NSE: LUPIN) was trading lower on Monday, slipping 2.45% to ₹2,082.90 on the NSE as of 11:21 am IST. The stock opened at ₹2,135.30 and touched an intraday high of ₹2,148, before sliding to a low of ₹2,078.20. Lupin currently commands a market capitalisation of ₹95.15 lakh crore and is valued at a P/E ratio of 22.04. The stock has moved between a 52-week high of ₹2,226.30 and a 52-week low of ₹1,795.20.

Conclusion

The launch of Dasatinib Tablets marks another key step in Lupin’s US growth strategy. By entering a nearly $1 billion oncology market, the company strengthens its position in complex generics while expanding access to affordable cancer treatments.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.