Lapatinib Ditosylate

Overview

Lapatinib Ditosylate is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1201179).

API suppliers (9)

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

• Formosa Laboratories, Inc.Taiwan1 active DMF GMP on record
• Hetero Labs LimitedIndia1 active DMF GMP on record
• ALP PHARM BEIJING CO LTD1 active DMF
• CAMBREX CHARLES CITY INCUnited States1 active DMF
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• DELMAR CHEMICALS INCCanada1 active DMF
• CHEMWERTH INCFrance1 active DMF
• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• Granules India LimitedIndia GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (3 approved US products), the latest listed US patent on Lapatinib Ditosylate expires 18 Sept 2029. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]furan-2-yl]quinazolin-4-amine;bis(4-methylbenzenesulfonic acid);hydrate

Canonical SMILES

CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CS(=O)(=O)CCNCC1=CC=C(O1)C2=CC3=C(C=C2)N=CN=C3NC4=CC(=C(C=C4)OCC5=CC(=CC=C5)F)Cl.O

InChIKey

XNRVGTHNYCNCFF-UHFFFAOYSA-N