Darolutamide

Overview

Darolutamide is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL4297185).

API suppliers (6)

Suppliers of Darolutamide 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 LimitedIndia2 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• CHANGZHOU PHARMACEUTICAL FACTORYChina1 active DMF GMP on record
• SICHUAN ELIXIR PHARMACEUTICAL CO LTD1 active DMF
• Aurisco Pharmaceutical Co.,ltdChina1 active DMF GMP on record
• FERMION OYFinland GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Darolutamide expires 17 Jun 2042 and exclusivity 3 Jun 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

N-[(2S)-1-[3-(3-chloro-4-cyanophenyl)pyrazol-1-yl]propan-2-yl]-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide

Canonical SMILES

C[C@@H](CN1C=CC(=N1)C2=CC(=C(C=C2)C#N)Cl)NC(=O)C3=NNC(=C3)C(C)O

InChIKey

BLIJXOOIHRSQRB-PXYINDEMSA-N