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

Stem definition	Drug id	CAS RN
androgens/anabolic steroids	2608	5949-44-0

Description:

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

Molecule

Description

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: ONP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 5, 2014	FDA	ENDO PHARMS INC

FDA Adverse Event Reporting System (Female)

None

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
Pulmonary oil microembolism	321.84	32.20	36	1246	12	34955637
Cough	115.15	32.20	70	1212	150070	34805579
Blood testosterone decreased	76.91	32.20	20	1262	4337	34951312
Drug ineffective	75.07	32.20	87	1195	456664	34498985
Pulmonary microemboli	70.49	32.20	8	1274	4	34955645
Microembolism	62.90	32.20	8	1274	23	34955626
Inappropriate schedule of product administration	44.71	32.20	28	1254	62268	34893381

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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
Pulmonary oil microembolism	244.00	27.90	25	1020	16	79743327
Cough	80.16	27.90	53	992	366736	79376607
Pulmonary microemboli	54.56	27.90	6	1039	13	79743330
Blood testosterone decreased	53.62	27.90	11	1034	2366	79740977
Microembolism	30.80	27.90	4	1041	47	79743296
Inappropriate schedule of product administration	30.62	27.90	20	1025	133608	79609735

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FDA Adverse Event Reporting System (Pediatric)

None

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
Hypogonadotropic hypogonadism	indication	33927004
Deficiency or absence of endogenous testosterone	indication	38825009
Primary hypogonadism	indication	370999003

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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	KYZATREX	MARIUS PHARMS LLC	N213953	July 27, 2022	RX	CAPSULE	ORAL	10576089	Dec. 31, 2030	METHOD OF TREATING TESTOSTERONE DEFICIENCY
100MG	KYZATREX	MARIUS PHARMS LLC	N213953	July 27, 2022	RX	CAPSULE	ORAL	11617758	March 15, 2033	METHOD OF TREATING TESTOSTERONE DEFICIENCY
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	11304960	Jan. 8, 2029	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	8778922	Jan. 8, 2029	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	8865695	Jan. 8, 2029	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	10226473	Nov. 30, 2030	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	10716794	Nov. 30, 2030	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	11311555	Nov. 30, 2030	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	11364249	Nov. 30, 2030	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	11433083	Nov. 30, 2030	TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	KYZATREX	MARIUS PHARMS LLC	N213953	July 27, 2022	RX	CAPSULE	ORAL	July 27, 2025	NEW PRODUCT
112.5MG	TLANDO	ANTARES PHARMA INC	N208088	March 28, 2022	RX	CAPSULE	ORAL	March 28, 2025	NEW PRODUCT
150MG	KYZATREX	MARIUS PHARMS LLC	N213953	July 27, 2022	RX	CAPSULE	ORAL	July 27, 2025	NEW PRODUCT
200MG	KYZATREX	MARIUS PHARMS LLC	N213953	July 27, 2022	RX	CAPSULE	ORAL	July 27, 2025	NEW PRODUCT

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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
004105	NDDF
10379	RXNORM
109033004	SNOMEDCT_US
15462	MMSL
1900	INN_ID
2966	MMSL
395900004	SNOMEDCT_US
4017484	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Aveed	HUMAN PRESCRIPTION DRUG LABEL	1	67979-511	INJECTION	250 mg	INTRAMUSCULAR	NDA	29 sections
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	69087-158	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	69087-198	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
Jatenzo	HUMAN PRESCRIPTION DRUG LABEL	1	69087-237	CAPSULE, LIQUID FILLED	237 mg	ORAL	NDA	32 sections
Kyzatrex	HUMAN PRESCRIPTION DRUG LABEL	1	80603-101	CAPSULE, LIQUID FILLED	100 mg	ORAL	NDA	36 sections
Kyzatrex	HUMAN PRESCRIPTION DRUG LABEL	1	80603-103	CAPSULE, LIQUID FILLED	150 mg	ORAL	NDA	36 sections

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