testosterone enantate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
androgens/anabolic steroids	4609	315-37-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: testosterone enanthate testosterone heptylate testosterone oenanthate testosterone enantate	Molecular weight: 400.60 Formula: C26H40O3 CLOGP: 7 LIPINSKI: 1 HAC: 3 HDO: 0 TPSA: 43.37 ALOGS: -5.94 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

testosterone enanthate
testosterone heptylate
testosterone oenanthate
testosterone enantate

Molecular weight: 400.60
Formula: C26H40O3
CLOGP: 7
LIPINSKI: 1
HAC: 3
HDO: 0
TPSA: 43.37
ALOGS: -5.94
ROTB: 7

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Dec. 24, 1953	FDA	ENDO PHARMS

FDA Adverse Event Reporting System (Female)

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Product dose omission issue	132.32	36.55	67	1019	119644	34836201
Device dislocation	132.02	36.55	32	1054	6217	34949628
Device malfunction	125.09	36.55	34	1052	10387	34945458
Drug ineffective	50.91	36.55	66	1020	456685	34499160
Accidental exposure to product	39.95	36.55	15	1071	12787	34943058
Secondary hypogonadism	39.34	36.55	7	1079	295	34955550
Faecal calprotectin increased	38.53	36.55	10	1076	2534	34953311
Pharyngitis streptococcal	38.00	36.55	10	1076	2674	34953171

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Device malfunction	139.90	40.62	40	1655	21408	79721285
Device dislocation	132.34	40.62	40	1655	25930	79716763
Product dose omission issue	102.20	40.62	64	1631	247473	79495220
Ear congestion	56.60	40.62	13	1682	2906	79739787
Migraine	44.61	40.62	26	1669	87467	79655226

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
CHEBI has role	CHEBI:50113	androgene
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:83056	Daphnia magna metabolites
FDA CS	M0001109	Androstanes
FDA EPC	N0000175824	Androgen
FDA MoA	N0000000146	Androgen Receptor Agonists
MeSH PA	D000728	Androgens
MeSH PA	D006728	Hormones

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Deficiency of testosterone biosynthesis	indication	38825009
Male hypogonadism	indication	48723006
Menopausal flushing	indication	198436008
Undescended testicle	indication	204878001	DOID:11383
Delayed puberty	indication	400003000
Klinefelter's syndrome, XXY	indication	405769009
Hormone receptor positive malignant neoplasm of breast	indication	417181009
LHRH Deficiency	indication
Hyperlipoproteinemia	contraindication	3744001	DOID:1168
Gynecomastia	contraindication	4754008	DOID:12698

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG/0.5ML (100MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	10821072	June 4, 2033	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
100MG/0.5ML (100MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	11160751	Oct. 7, 2034	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
100MG/0.5ML (100MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	10238662	Feb. 19, 2035	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
100MG/0.5ML (100MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	10912782	Feb. 19, 2035	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
100MG/0.5ML (100MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	9950125	Sept. 4, 2036	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
50MG/0.5ML (50MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	10821072	June 4, 2033	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
50MG/0.5ML (50MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	11160751	Oct. 7, 2034	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
50MG/0.5ML (50MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	10238662	Feb. 19, 2035	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
50MG/0.5ML (50MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	10912782	Feb. 19, 2035	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY
50MG/0.5ML (50MG/0.5ML)	XYOSTED (AUTOINJECTOR)	ANTARES PHARMA INC	N209863	Sept. 28, 2018	RX	SOLUTION	SUBCUTANEOUS	9950125	Sept. 4, 2036	METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN	AGONIST				CHEMBL	CHEMBL

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External reference:

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ID	Source
TES	PDB_CHEM_ID
001245	NDDF
001247	NDDF
10379	RXNORM
109033004	SNOMEDCT_US
116071004	SNOMEDCT_US
1900	INN_ID
2966	MMSL
3019	MMSL
4017482	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
TESTOSTERONE ENANTHATE	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9750	INJECTION, SOLUTION	200 mg	INTRAMUSCULAR	ANDA	28 sections
XYOSTED	HUMAN PRESCRIPTION DRUG LABEL	1	54436-200	INJECTION	100 mg	SUBCUTANEOUS	NDA	34 sections
XYOSTED	HUMAN PRESCRIPTION DRUG LABEL	1	54436-200	INJECTION	100 mg	SUBCUTANEOUS	NDA	34 sections
XYOSTED	HUMAN PRESCRIPTION DRUG LABEL	1	54436-250	INJECTION	50 mg	SUBCUTANEOUS	NDA	34 sections
XYOSTED	HUMAN PRESCRIPTION DRUG LABEL	1	54436-250	INJECTION	50 mg	SUBCUTANEOUS	NDA	34 sections
XYOSTED	HUMAN PRESCRIPTION DRUG LABEL	1	54436-275	INJECTION	75 mg	SUBCUTANEOUS	NDA	34 sections
XYOSTED	HUMAN PRESCRIPTION DRUG LABEL	1	54436-275	INJECTION	75 mg	SUBCUTANEOUS	NDA	34 sections

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