Apotex launches nilotinib capsules, the first generic version of Tasigna®¹ in the United States, with 180 days of exclusivity

May 25, 2025

Weston, Florida (May 23, 2025) – Apotex Corp. today announced the launch of nilotinib capsules, a generic version of Tasigna®¹, in the United States, with 180 days of exclusivity.

Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. It is also indicated for adults and pediatric patients with chronic or accelerated phase Ph+ CML with resistance or intolerance to prior therapy, demonstrating higher efficacy compared with other available treatments.

"The launch of nilotinib highlights our commitment to providing affordable, high-quality, critical medications to patients in need," said Christine Baeder, President, Apotex USA. "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."

Please refer to the complete prescribing information, patient information leaflet, warnings and precautions, adverse reactions, and contraindications.

About Apotex

Apotex Corp., headquartered in Weston, Florida, is an affiliate of Apotex Inc. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic and innovative pharmaceutical and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Learn more about us at www.apotex.com.

All media inquiries:

Apotex Media

media@apotex.com

¹ Tasigna® is a registered trademark of Novartis AG

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May 25, 2025
Apotex launches nilotinib capsules, the first generic version of Tasigna®¹ in the United States, with 180 days of exclusivity

Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. It is also indicated for adults and pediatric patients with chronic or accelerated phase Ph+ CML with resistance or intolerance to prior therapy, demonstrating higher efficacy compared with other available treatments.
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