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Last Updated: December 16, 2019

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TESTOSTERONE Drug Profile

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When do Testosterone patents expire, and what generic alternatives are available?

Testosterone is a drug marketed by Actavis Labs Ut Inc, Amneal Pharms Llc, Dr Reddys, Lupin Atlantis, Perrigo Israel, Twi Pharms, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Cipla, Lupin Ltd, Am Regent, Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Wilshire Pharms Inc, Nexus Pharms, Bel Mar, Elkins Sinn, and Lilly. and is included in forty-nine NDAs.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Drug patent expirations by year for TESTOSTERONE
Drug Prices for TESTOSTERONE

See drug prices for TESTOSTERONE

Drug Sales Revenue Trends for TESTOSTERONE

See drug sales revenues for TESTOSTERONE

Recent Clinical Trials for TESTOSTERONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aga Khan UniversityPhase 2
ECOG-ACRIN Cancer Research GroupPhase 2
Xiao X. WeiPhase 2

See all TESTOSTERONE clinical trials

Recent Litigation for TESTOSTERONE

Identify potential future generic entrants

District Court Litigation
Case NameDate
ACRUX DDS PTY LTD. v. SANDOZ INC.2017-10-23
Unimed Pharmaceuticals, LLC v. TWi Pharmaceuticals, Inc.2016-09-16
Eli Lilly and Company v. Perrigo Company2016-08-24

See all TESTOSTERONE litigation

Pharmacology for TESTOSTERONE
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for TESTOSTERONE
Synonyms for TESTOSTERONE
(17?)-17-Hydroxyandrost-4-en-3-one
(17beta)-17-Hydroxyandrost-4-en-3-one
(1S,2R,10R,11S,14S,15S)-14-hydroxy-2,15-dimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadec-6-en-5-one
(8alpha,10alpha,13alpha,14beta,17alpha)-17-hydroxyandrost-4-en-3-one
(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17S)-17-Hydroxy-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one
003T654
1050678-68-6
17-.beta.-Hydroxyandrost-4-en-3-one
17-beta-Hydroxy-delta(sup 4)-androsten-3-one
17-beta-Hydroxyandrost-4-en-3-one
17-Hydroxy-(17-beta)-androst-4-en-3-one
17-Hydroxy-(17beta)-androst-4-en-3-one
17-Hydroxyandrost-4-en-3-one, (17.beta.)-
17.beta.-Hydroxy-.DELTA.4-androsten-3-one
17.beta.-Testosterone
17b-hydroxy-4-androsten-3-one
17beta-Hydroxy-4-androsten-3-one
17beta-hydroxy-4-androsten-3one
17beta-Hydroxy-delta(sup4)-androsten-3-one
17beta-Hydroxyandrost-4-en-3-one
17beta-Hydroxyandrost-4-ene-3-one
1i37
3kdm
3XMK78S47O
4-Androsten-17.beta.-ol-3-one
4-Androsten-17beta-ol-3-one
4-Androsten-3-one-17.beta.-ol
4-Androsten-3-one, 17b-hydroxy-
4-androstene-17beta-ol-3-one
58-22-0
7-beta-Hydroxyandrost-4-en-3-one
AA 2500
AB00973630-03
AC-14899
AC1L1LM0
AKOS015894897
AN-23597
Andro 100
Androderm
Androderm (TN)
Androderm, Delatestryl
AndroGel
Androgel (TN)
Androgel 1.62%
Androgel 1%
Androlin
Andronaq
Andronate 100
Andronate 200
Andropatch
Andropository 200
Androsorb
Androst-4-en-17beta-ol-3-one
Androst-4-en-3-on-17B-ol
Androst-4-en-3-one, 17-beta-hydroxy-
Androst-4-en-3-one, 17-hydroxy-, (17-beta)-
Androst-4-en-3-one, 17-hydroxy-, (17.beta.)-
Androst-4-en-3-one, 17-hydroxy-, (17b)-
Androst-4-en-3-one, 17-hydroxy-, (17beta)-
Androst-4-en-3-one, 17-hydroxy, (17.beta.)-
Androst-4-en-3-one, 17beta-hydroxy-
Andrusol
Andryl 200
Axiron
Axiron (TN)
B5DEE83F-632B-48A1-A0ED-A51E7F13DF2E
BC208298
BDBM8885
beta testosterone
BIDD:ER0555
BIM-0061761.0001
Bio-T-Gel
C-18145
C00535
CAS-58-22-0
CCG-101189
CCRIS 574
CDB 111C
CHEBI:17347
CHEMBL386630
CMC_13449
COL 1621
CompleoTRT
component of Di-Genik (Salt/Mix)
component of Di-Met (Salt/Mix)
component of Duogen (Salt/Mix)
component of Intrinsa (Salt/Mix)
component of Mal-O-Fem (Salt/Mix)
component of Tostrex (Salt/Mix)
CP 601B
CPD000058344
Cristerona T
Cristerone T
CS-1415
D00075
DB00624
delta(sup 4)-Androsten-17(beta)-ol-3-one
delta4-androsten-17b-ol-3-one
delta4-Androsten-17beta-ol-3-one
DSSTox_CID_2371
DSSTox_GSID_22371
DSSTox_RID_76563
DTXSID8022371
EC 200-370-5
EINECS 200-370-5
Epitope ID:135865
Everone 200
Fortesta
Geno-cristaux gremy
GTPL2858
Halotensin
HMS2052N11
HMS2272B03
HMS2272P03
Homosteron
Homosterone
HSDB 3398
HY-15554A
Intrinsa
LibiGel
LMST02020002
LPCN 1021
LS-148813
Malerone
Malestrone (amps)
Malogen in Oil
Malogen, aquaspension injection
MCULE-1294118086
Mertestate
MLS000563091
MLS001032098
MLS001306401
MLS001424262
MLS002174283
mpp10
MUMGGOZAMZWBJJ-DYKIIFRCSA-N
Nasobol
Natesto
NC00439
NCGC00091018-01
NCGC00258243-01
Neo-Hombreol F
Neo-testis
Neotestis
NSC 9700
Oreton
Oreton F
Oreton-F
Orquisteron
Perandren
Percutacrine androgenique
Primotest
Primoteston
Q-101251
RB3046
Relibra
RP29985
S00309
SC-15109
Scheinpharm Testone-Cyp
SCHEMBL8452
SMR000058344
SMR001261453
Striant
Striant (TN)
Sustanon
Sustanone
Sustason 250
Synandrol F
T-Cypionate
Tefina
Teslen
Testamone 100
Testandrone
Testaqua
Testiculosterone
Testim
Testim (TN)
Testobase
Testoderm
Testoderm Tts
Testogel
Testoject-50
Testolin
Testopel Pellets
Testopropon
Testosteroid
Testosteron
Testosterona
Testosterona [INN-Spanish]
Testosterone (JAN/USP)
Testosterone [Androgenic steroids, anabolic]
Testosterone [INN:BAN]
Testosterone [USP:INN:BAN]
Testosterone 1.0 mg/ml in Acetonitrile
Testosterone 100 microg/mL in Acetonitrile
Testosterone and its esters
Testosterone for impurity D identification, European Pharmacopoeia (EP) Reference Standard
Testosterone for system suitability, European Pharmacopoeia (EP) Reference Standard
Testosterone hydrate
Testosterone solution, 1.0 mg/mL in 1,2-dimethoxyethane, drug standard
Testosterone solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Testosterone, >=98%
Testosterone, 1
Testosterone, cell culture tested
Testosterone, European Pharmacopoeia (EP) Reference Standard
Testosterone, purum, >=99.0% (HPLC)
Testosterone, VETRANAL(TM), analytical standard
Testosterone; 4-Androsten-17?-ol-3-one; 17?-Hydroxy-4-androsten-3-one
Testosteronum
Testosteronum [INN-Latin]
Testostosterone
Testoviron
Testoviron Schering
Testoviron T
Testred Cypionate 200
Testrin-P.A
Testro AQ
Testrone
Testryl
Tlando
Tox21_200689
trans-Testosterone
UNII-3XMK78S47O
Virilon IM
Virormone
Virosterone
Vogelxo
W-5033
ZINC118912393
Paragraph IV (Patent) Challenges for TESTOSTERONE
Tradename Dosage Ingredient NDA Submissiondate
AXIRON SOLUTION, METERED;TRANSDERMAL testosterone 022504 2013-01-29
FORTESTA GEL, METERED;TRANSDERMAL testosterone 021463 2012-08-14
TESTIM GEL;TRANSDERMAL testosterone 021454 2008-08-21

US Patents and Regulatory Information for TESTOSTERONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Pharms Inc TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 086030-001 Approved Prior to Jan 1, 1982 AO RX No No   Start Trial   Start Trial   Start Trial
Mylan Institutional TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 040652-001 Dec 11, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 083667-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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