Lupin rolls out cancer drug dasatinib in US after FDA nod

MUMBAI, NAPLES (FLORIDA): Lupin Limited has launched dasatinib tablets in the United States after receiving approval from the US Food and Drug Administration for its abbreviated new drug application. The product has been developed in partnership with Pharmascience Inc.

The tablets are available in strengths ranging from 20 mg to 140 mg and are bioequivalent to Sprycel, the branded drug marketed by Bristol Myers Squibb. Dasatinib is used to treat Philadelphia chromosome-positive chronic myeloid leukaemia across various stages, as well as Philadelphia chromosome-positive acute lymphoblastic leukaemia in both adult and paediatric patients.

According to IQVIA data, Sprycel recorded estimated annual sales of $930 million in the US for the 12 months ended October 2025, underlining the commercial potential of Lupin’s generic launch.

Headquartered in Mumbai, Lupin operates across more than 100 markets and has a strong presence in branded and generic medicines, complex generics, biotechnology products and active pharmaceutical ingredients.

Pharmascience, based in Montreal, is among Canada’s largest pharmaceutical manufacturers, supplying medicines to over 50 countries worldwide.