Zanubrutinib

Overview

Zanubrutinib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL3936761).

API suppliers (2)

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

• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• OLON SPAItaly1 active DMF GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Zanubrutinib expires 19 Jan 2043 and exclusivity 7 Mar 2031. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

(7S)-2-(4-phenoxyphenyl)-7-(1-prop-2-enoylpiperidin-4-yl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide

Canonical SMILES

C=CC(=O)N1CCC(CC1)[C@@H]2CCNC3=C(C(=NN23)C4=CC=C(C=C4)OC5=CC=CC=C5)C(=O)N

InChIKey

RNOAOAWBMHREKO-QFIPXVFZSA-N