Nilotinib

Overview

Nilotinib is a tyrosine kinase inhibitor used in the treatment of chronic myeloid leukemia. It works by blocking the BCR-ABL kinase and improving patient outcomes in cases resistant to previous treatments.

API suppliers (5)

Suppliers of Nilotinib backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• MSN Laboratories Private LimitedIndia4 active DMF
• Sichuan Baili Pharmaceutical Co., Ltd.China1 active DMF
• Hetero Labs LimitedIndia1 active DMF
• Zhejiang Hisun Pharmaceutical Co., Ltd.China
• FIS FABBRICA ITALIANA SINTETICI SPA

Patent & exclusivity (US)

Per the FDA Orange Book (20 approved US products), the latest listed US patent on Nilotinib expires 18 Feb 2040 and exclusivity 23 Mar 2029. Generic API sourcing typically opens up once these lapse.

Therapeutic areas