DrugPatentWatch Database Preview

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 eighteen branded drugs marketed by Allergan Sales Llc, Alza, Aytu Bioscience Inc, 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 Ltd, Lupin Ltd, Pharmacia And Upjohn, Hikma Farmaceutica, Luitpold Pharms Inc, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Bel Mar, Elkins Sinn, Lilly, and Endo Pharms Inc, and is included in fifty-four NDAs. There are forty-one 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 seventy-nine patent family members in forty-seven countries.

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

Summary for testosterone

International Patents:	379
US Patents:	41
Tradenames:	18
Applicants:	30
NDAs:	54
Drug Master File Entries:	63
Suppliers / Packagers:	20
Bulk Api Vendors:	63
Clinical Trials:	763
Patent Applications:	7,270
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for testosterone
DailyMed Link:	testosterone at DailyMed

Pharmacology for testosterone

Ingredient-type	Androstanes
Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for testosterone

Androgens

Synonyms for testosterone

(+-)-8-iso-testosterone
(+-)-retrotestosterone
(+-)-testosterone
(+)-testosterone
(17?)-17-Hydroxyandrost-4-en-3-one
(17b)-17-hydroxy-androst-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
(1S,2R,10R,11S,14S,15S)-14-HYDROXY-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]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
13-iso-testosterone
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-Hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-cyclopenta[a]phenanthren-3-one
17-Hydroxy-4-androsten-3-one
17-hydroxy-androst-4-en-3-one
17-hydroxy-D4-androsten-3-one
17-Hydroxyandrost-4-en-3-one, (17.beta.)-
17.beta.-Hydroxy-.DELTA.4-androsten-3-one
17.beta.-Testosterone
17a-hydroxy-(13a)-androst-4-en-3-one
17a-hydroxy-13a-androst-4-en-3-one
17a-hydroxy-14b-androst-4-en-3-one
17a-hydroxy-androst-4-en-3-one
17b-hydroxy-(10a)-androst-4-en-3-one
17b-hydroxy-(13a)-androst-4-en-3-one
17b-hydroxy-(8a,10a)-androst-4-en-3-one
17b-hydroxy-(8a)-androst-4-en-3-one
17b-hydroxy-(9b,10a)-androst-4-en-3-one
17b-hydroxy-(9b)-androst-4-en-3-one
17b-hydroxy-13a-androst-4-en-3-one
17b-hydroxy-4-androsten-3-one
17b-hydroxy-8a-androst-4-en-3-one
17b-Hydroxy-androst-4-en-3-on
17b-hydroxy-androst-4-en-3-one
17b-Hydroxy-D4-androsten-3-one
17b-Hydroxyandrost-4-ene-3-one
17b-Testosterone
17beta-Hydroxy-3-oxo-4-androstene
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
17beta-testosterone
1i37
3kdm
3XMK78S47O
4-androsten-17-ol-3-one
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-ol
4-Androsten-3-one, 17b-hydroxy-
4-androstene-17beta-ol-3-one
58-22-0
7-beta-Hydroxyandrost-4-en-3-one
8-iso-testosterone
9b-testosterone
9b,10a-testosterone
AA 2500
AB00973630-03
AC-14899
AC1L1LM0
AK405367
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-17b-ol-3-one
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-
Androst-4-ene-17b-ol-3-one
Andrusol
Andryl 200
Axiron
Axiron (TN)
B5DEE83F-632B-48A1-A0ED-A51E7F13DF2E
BC208298
BDBM8885
beta testosterone
BIDD:ER0555
BIM-0061761.0001
Bio-0678
Bio-T-Gel
BT000432
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
D06XMU
D4-Androsten-17b-ol-3-one
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
EINECS 200-370-5
Epitestosteron
Epitope ID:135865
Everone 200
Fortesta
Geno-cristaux gremy
GTPL2858
Halotensin
HMS2052N11
HMS2272B03
HMS2272P03
Homosteron
Homosterone
HSDB 3398
HY-15554A
Intrinsa
LibiGel
LMST02020002
LS-148813
Lumitestosteron
Malerone
Malestrone (amps)
Malogen in Oil
Malogen, aquaspension injection
MCULE-1294118086
Mertestate
MLS000563091
MLS001032098
MLS001306401
MLS001424262
MLS002174283
mpp10
MUMGGOZAMZWBJJ-DYKIIFRCSA-N
Nasobol
NC00439
NCGC00091018-01
NCGC00258243-01
Neo-Hombreol F
Neo-testis
Neotestis
NSC 9700
Oreton
Oreton F
Oreton-F
Orquisteron
Perandren
Percutacrine androgenique
PL000185
Primotest
Primoteston
Q-101251
rac-17b-hydroxy-(13a)androst-4-en-3-one
rac-17b-hydroxy-(8a)-androst-4-en-3-one
rac-17b-hydroxy-(9b,10a)androst-4-en-3-one
rac-17b-hydroxy-androst-4-en-3-one
RB3046
Relibra
RP29985
S00309
SC-15109
Scheinpharm Testone-Cyp
SCHEMBL8452
SMR000058344
SMR001261453
Striant
Striant (TN)
Sustanon
Sustanone
Sustason 250
Synandrol F
T-Cypionate
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
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
Tostrelle
Tostrex
Tox21_200689
trans-Testosterone
UNII-3XMK78S47O
Viatrel
Virilon IM
Virormone
Virosterone
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
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial	Y			➤ Try a Free Trial
Sun Pharm Inds Ltd	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	201720-002	Jun 3, 2013	AO	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Watson Labs	TESTOSTERONE ENANTHATE	testosterone enanthate	INJECTABLE;INJECTION	083667-002	Approved Prior to Jan 1, 1982		DISCN	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Bel Mar	TESTOSTERONE PROPIONATE	testosterone propionate	INJECTABLE;INJECTION	080741-001	Approved Prior to Jan 1, 1982		DISCN	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ 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

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Expired US Patents for testosterone

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 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
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	➤ Try a Free Trial	➤ Try a Free Trial
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for testosterone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
8,177,449	Spreading implement	➤ Try a Free Trial
9,579,280	Controlled release delivery system for nasal applications and method of treatment	➤ Try a Free Trial
6,699,494	Pharmaceutical composition and method for treating premature labor	➤ Try a Free Trial
2,014,073,618		➤ Try a Free Trial
Patent No.	Title	Estimated Patent Expiration

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International Patents for testosterone

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Country	Document Number	Estimated Expiration
Japan	2004500317	➤ Try a Free Trial
Brazil	PI0720945	➤ Try a Free Trial
Japan	2005519985	➤ Try a Free Trial
Japan	4139860	➤ Try a Free Trial
Country	Document Number	Estimated Expiration