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 (9)
Suppliers of Nilotinib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 8 of 9 suppliers.
5 of 9 hold a GMP certificate on record in the EU or UK registers
- MSN Laboratories Private LimitedIndia4 active DMF GMP on record
- SICHUAN ELIXIR PHARMACEUTICAL CO LTD1 active DMF
- Teva Pharmaceutical Industries Ltd.Israel1 active DMF GMP on record
- SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
- TAPI NL BVNetherlands1 active DMF
- Hetero Labs LimitedIndia1 active DMF GMP on record
- Zhejiang Jiuzhou Pharmaceutical Co., Ltd.China GMP on record
- Sichuan Xieli Pharmaceutical Co LtdChina
- FIS FABBRICA ITALIANA SINTETICI SPAItaly GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (23 approved US products), the latest listed US patent on Nilotinib expires 30 Apr 2041 and exclusivity 23 Mar 2029. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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