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Testosterone - Generic Drug Details

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

Testosterone is the generic ingredient in nineteen branded drugs marketed by Allergan Sales Llc, Alza, Aytu, Abbvie, Endo Pharms, Actavis Labs Ut Inc, Perrigo Israel, Upsher Smith Labs, Auxilium Pharms Llc, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Auxilium Pharms Inc, Eli Lilly And Co, Cipla, Lupin Ltd, Pharmacia And Upjohn, Hikma Farmaceutica, Luitpold, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Nexus Pharms, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, and Endo Pharms Inc, and is included in fifty-six NDAs. There are forty-eight patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Testosterone has three hundred and sixty-five patent family members in forty-seven countries.

There are sixty-nine drug master file entries for testosterone. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for testosterone

International Patents:	365
US Patents:	48
Tradenames:	19
Applicants:	32
NDAs:	56
Drug Master File Entries:	69
Suppliers / Packagers:	17
Bulk Api Vendors:	59
Clinical Trials:	829
Patent Applications:	7,260
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for testosterone
Drug Sales Revenues:	Drug sales revenues for testosterone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for testosterone
DailyMed Link:	testosterone at DailyMed

Pharmacology for testosterone

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for testosterone

Androgens

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

Tentative approvals for TESTOSTERONE

Applicant	Application No.	Strength	Dosage Form
➤ Try a Free Trial	➤ Try a Free Trial	30MG/1.5ML	SOLUTION;TOPICAL

US Patents and Regulatory Information for testosterone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Ut Inc	TESTOSTERONE	testosterone	GEL;TRANSDERMAL	091073-001	Sep 18, 2017	AB2	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Nexus Pharms	TESTOSTERONE ENANTHATE	testosterone enanthate	INJECTABLE;INJECTION	040575-001	Jun 14, 2006	AO	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018		RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial	Y			➤ Try a Free Trial
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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Auxilium Pharms Llc	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	➤ Try a Free Trial	➤ Try a Free Trial
Endo Pharms	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010	➤ Try a Free Trial	➤ Try a Free Trial
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for testosterone

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Country	Patent Number	Estimated Expiration
Japan	5728508	➤ Try a Free Trial
South Africa	201604587	➤ Try a Free Trial
Poland	366117	➤ Try a Free Trial
Country	Patent Number	Estimated Expiration