testosterone undecanoate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
androgens/anabolic steroids 2608 5949-44-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • testosterone undecanoate
  • testosterone undecylate
  • Molecular weight: 456.71
  • Formula: C30H48O3
  • CLOGP: 9.12
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 0
  • TPSA: 43.37
  • ALOGS: -6.79
  • ROTB: 11

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 5, 2014 FDA ENDO PHARMS INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
MeSH PA D000728 Androgens
MeSH PA D006728 Hormones

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypogonadotropic hypogonadism indication 33927004
Primary hypogonadism indication 370999003

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
158MG JATENZO CLARUS N206089 March 27, 2019 RX CAPSULE ORAL March 27, 2022 NEW PRODUCT
198MG JATENZO CLARUS N206089 March 27, 2019 RX CAPSULE ORAL March 27, 2022 NEW PRODUCT
237MG JATENZO CLARUS N206089 March 27, 2019 RX CAPSULE ORAL March 27, 2022 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Androgen receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL

External reference:

IDSource
4033172 VUID
N0000190487 NUI
D06087 KEGG_DRUG
4033172 VANDF
C0076195 UMLSCUI
CHEBI:135741 CHEBI
CHEMBL2107067 ChEMBL_ID
C010792 MESH_SUPPLEMENTAL_RECORD_UI
DB13946 DRUGBANK_ID
H16A5VCT9C UNII
65157 PUBCHEM_CID
37864 RXNORM
15462 MMSL
004105 NDDF
395900004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Aveed HUMAN PRESCRIPTION DRUG LABEL 1 67979-511 INJECTION 250 mg INTRAMUSCULAR NDA 29 sections
Jatenzo HUMAN PRESCRIPTION DRUG LABEL 1 69087-158 CAPSULE, LIQUID FILLED 158 mg ORAL NDA 32 sections
Jatenzo HUMAN PRESCRIPTION DRUG LABEL 1 69087-198 CAPSULE, LIQUID FILLED 198 mg ORAL NDA 32 sections
Jatenzo HUMAN PRESCRIPTION DRUG LABEL 1 69087-237 CAPSULE, LIQUID FILLED 237 mg ORAL NDA 32 sections