Darolutamide

CAS 1297538-32-9 6 FDA-DMF suppliersSmall Molecule

Overview

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

API suppliers (6)

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

  • MSN Laboratories Private LimitedIndia2 active DMF
  • Alembic Pharmaceuticals LimitedIndia1 active DMF
  • CHANGZHOU PHARMACEUTICAL FACTORYChina1 active DMF
  • Sichuan Baili Pharmaceutical Co., Ltd.China1 active DMF
  • Ono Pharmaceutical Co., Ltd.Japan1 active DMF
  • FERMION OYFinland

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

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