A generic version of nilotinib (Tasigna®) entered the US market on May 27, 2025, with 180 days of exclusivity, reported Apotex, the pharmaceutical company that introduced the therapy to the US market.
Nilotinib treats Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults and children ages 1 and older, including newly diagnosed chronic phase and relapsed or refractory chronic or accelerated phase Ph+ CML resistant to prior therapy.
“The launch of nilotinib highlights our commitment to providing affordable, high-quality, critical medications to patients in need,” Christine Baeder, President, Apotex USA, said in a company press release. “By offering the first generic version of this important leukemia treatment, we improve access and outcomes for both adult and pediatric patients facing this serious disease.”
Tasigna® is a branded version of nilotinib developed by the pharmaceutical giant Novartis.
