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Last Updated: October 16, 2019

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Testosterone enanthate - Generic Drug Details

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What are the generic drug sources for testosterone enanthate and what is the scope of freedom to operate?

Testosterone enanthate is the generic ingredient in three branded drugs marketed by Endo Pharms, Hikma Farmaceutica, Mylan Institutional, Nexus Pharms, Watson Labs, Watson Pharms Inc, and Antares Pharma Inc, and is included in eight NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Testosterone enanthate has forty-nine patent family members in fourteen countries.

There are sixty-nine drug master file entries for testosterone enanthate. Three suppliers are listed for this compound.

Drug Prices for testosterone enanthate

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Recent Clinical Trials for testosterone enanthate

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SponsorPhase
The University of Texas Medical Branch, GalvestonPhase 2/Phase 3
National Institute on Aging (NIA)Phase 2
Shalendar Bhasin, MDPhase 2

See all testosterone enanthate clinical trials

Recent Litigation for testosterone enanthate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Antares Pharma Inc. v. Medac Pharma Inc.2014-07-21

See all testosterone enanthate litigation

Pharmacology for testosterone enanthate
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Synonyms for testosterone enanthate
(8R,9S,10R,13S,14S,17S)-10,13-Dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl heptanoate
[(8R,9S,10R,13S,14S,17S)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] heptanoate
11111-10-7
17-((1-Oxoheptyl)oxy)androst-4-en-3-one
17-[(1-Oxoheptyl)oxy]androst-4-en-3-one
17-heptanoyl-17beta-hydroxyandrost-4-en-3-one
17-Hydroxyandrost-4-en-3-one, 17-heptanoate
17-Hydroxyandrost-4-en-3-one, 17-heptanoic acid
17beta-Enanthoxyandrost-4-en-3-one
17beta-Hydroxyandrost-4-en-3-one enanthate
17beta-hydroxyandrost-4-en-3-one heptanoate
3-Oxoandrost-4-en-17-yl heptanoate, (17.beta.)- #
3-oxoandrost-4-en-17beta-yl heptanoate
315-37-7
315T377
4-08-00-00979 (Beilstein Handbook Reference)
4-Androsten-17beta-ol-3-one 17-enanthate
4-Androsten-3-one 17.beta.-enanthate
4-Androsten-3-one 17beta-enanthate
7Z6522T8N9
91337-EP2284149A1
91337-EP2305636A1
AC-12599
AC1L1SZP
AKOS015960945
AN-44241
Andro L.A. 200
Androgyn L.A
Androgyn L.A.
Androgyn L.A. (Salt/Mix)
Andropository
Androst-4-en-3-one, 17-((1-oxoheptyl)oxy)-, (17beta)-
Androst-4-en-3-one, 17-(1-oxoheptyl)oxy-, (17beta)-
Androst-4-en-3-one, 17-[(1-oxoheptyl)oxy]-, (17.beta.)-
Androst-4-en-3-one, 17-[(1-oxoheptyl)oxy]-, (17b)-
Androst-4-en-3-one, 17.beta.-hydroxy-, heptanoate
Androst-4-en-3-one, 17beta-hydroxy-, heptanoate
Androst-4-en-3-one, heptanoate
Androst-4-en-3-one,(17.beta.)-
Androtardyl
Atlatest
BRN 3170544
C-21720
C08157
C26H40O3
CC-34818
CCRIS 7082
CHEBI:9464
CHEMBL1200335
D00958
DEA No. 4000
Deladumone (Salt/Mix)
Delatest
Delatestryl (TN)
DePatestrye
Depo-Testro Med
Ditate
Ditate (Salt/Mix)
DS-11585
Durathate
EINECS 206-253-5
Enanthic acid testosterone
Everone
Exten test
Heptanoic acid, ester with testosterone
LMST02020075
LS-148818
Malogen L.A
Malogen L.A.
Malogen L.A.200
MolPort-003-959-707
NSC-17591
NSC17591
Orquisteron-E
Primotestone
Reposo TMD
Reposo-TMD
SC-16227
SCHEMBL42687
SR-01000942262
SR-01000942262-1
Testanthate
Testate
Testenate
Testinon
Testoenant
Testonenant
Testosterone 17-enanthate
Testosterone 17beta-heptanoate
Testosterone 17beta-heptanoic acid
Testosterone enantate
Testosterone enantate for peak identification, European Pharmacopoeia (EP) Reference Standard
Testosterone enantate for system suitability, European Pharmacopoeia (EP) Reference Standard
Testosterone enantate, European Pharmacopoeia (EP) Reference Standard
Testosterone enanthate (JP17/USP)
Testosterone enanthate [USAN:JAN]
Testosterone enanthate [USP:JAN]
Testosterone enanthate, analytical standard
Testosterone enanthate, United States Pharmacopeia (USP) Reference Standard
Testosterone ethanate
Testosterone heptanoate
Testosterone heptoate
Testosterone heptoic acid
Testosterone heptylate
Testosterone oenanthate
Testosterone, heptanoate
Testostroval
Theramex
UNII-7Z6522T8N9
VOCBWIIFXDYGNZ-IXKNJLPQSA-N
W-106891
WLN: L E5 B666 OV MUTJ A E FOV6
ZINC3876080

US Patents and Regulatory Information for testosterone enanthate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Mylan Institutional TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 040647-001 Oct 5, 2009 DISCN No No   See Pricing   See Pricing   See Pricing
Endo Pharms DELATESTRYL testosterone enanthate INJECTABLE;INJECTION 009165-001 Approved Prior to Jan 1, 1982 DISCN No No   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for testosterone enanthate

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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Moodys
Medtronic
Mallinckrodt
Merck

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