Acalabrutinib

Overview

Acalabrutinib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL3707348).

API suppliers (4)

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

• MSN Laboratories Private LimitedIndia1 active DMF
• Cipla USA, Inc.USA1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF
• Natco PharmaIndia1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (2 approved US products), the latest listed US patent on Acalabrutinib expires 1 Jul 2036 and exclusivity 19 Feb 2029. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

4-[8-amino-3-[(2S)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-N-pyridin-2-ylbenzamide

Canonical SMILES

CC#CC(=O)N1CCC[C@H]1C2=NC(=C3N2C=CN=C3N)C4=CC=C(C=C4)C(=O)NC5=CC=CC=N5

InChIKey

WDENQIQQYWYTPO-IBGZPJMESA-N