Dasatinib

Overview

Dasatinib is a tyrosine kinase inhibitor used for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) with Philadelphia chromosome-positive (Ph+). It works by inhibiting the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality.

API suppliers (22)

Suppliers of Dasatinib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• Hubei Haosun Pharmaceutical Co., Ltd.China2 active DMF GMP on record
• TAPI NL BVNetherlands2 active DMF
• Hetero Labs LimitedIndia2 active DMF GMP on record
• MSN Laboratories Private LimitedIndia2 active DMF GMP on record
• Cipla USA, Inc.USA2 active DMF
• Granules India LimitedIndia2 active DMF GMP on record
• Reliance Life Sciences Pvt. Ltd.India1 active DMF GMP on record
• CDYMAX (INDIA) PHARMA PRIVATE LIMITEDIndia1 active DMF GMP on record
• Deva Holding As1 active DMF GMP on record
• SICHUAN ELIXIR PHARMACEUTICAL CO LTD1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• BIOCARE PHARMACEUTICAL LTDChina1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• DR REDDYS LABORATORIES LTD1 active DMF GMP on record
• Intas Pharmaceuticals Ltd.India1 active DMF GMP on record
• Biocon LimitedIndia1 active DMF
• Hikma Pharmaceuticals Usa IncUnited Kingdom1 active DMF
• ALP PHARM BEIJING CO LTD1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Sichuan Xieli Pharmaceutical Co LtdChina
• Zhejiang Hisun Pharmaceutical Co., Ltd.China GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (60 approved US products), the latest listed US patent on Dasatinib expires 22 Jan 2041 and exclusivity 5 Dec 2026. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamide

Canonical SMILES

CC1=C(C(=CC=C1)Cl)NC(=O)C2=CN=C(S2)NC3=CC(=NC(=N3)C)N4CCN(CC4)CCO

InChIKey

ZBNZXTGUTAYRHI-UHFFFAOYSA-N

Therapeutic areas