Acalabrutinib
Overview
Acalabrutinib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL3707348).
API suppliers (4)
Suppliers of Acalabrutinib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
3 of 4 hold a GMP certificate on record in the EU or UK registers
- Cipla USA, Inc.USA1 active DMF
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
- Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
- Natco PharmaIndia1 active DMF GMP on record
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
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