Testosterone - Generic Drug Details

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

Testosterone is the generic ingredient in twenty branded drugs marketed by Allergan Sales Llc, Alza, Aytu, Abbvie, Endo Pharms, Actavis Labs Ut Inc, Amneal Pharms Llc, Dr Reddys, Lupin Atlantis, Perrigo Israel, Twi Pharms, 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, 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, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Clarus, and Endo Pharms Inc, and is included in sixty-three NDAs. There are fifty-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 sixty-seven 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 are two tentative approvals for this compound.

Summary for testosterone

International Patents:	367
US Patents:	51
Tradenames:	20
Applicants:	38
NDAs:	63
Drug Master File Entries:	69
Suppliers / Packagers:	17
Bulk Api Vendors:	59
Clinical Trials:	854
Patent Applications:	7,288
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

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

Sponsor	Phase
Aga Khan University	Phase 2
University of Colorado, Denver	Phase 2/Phase 3
Feinstein Institute for Medical Research	Phase 2

See all testosterone clinical trials

Recent Litigation for testosterone

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 Company	2016-08-24

See all testosterone litigation

Generic filers with tentative approvals for TESTOSTERONE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL
Start Trial	Start Trial	750MG/3ML (250MG/ML)	INJECTABLE;INTRAMUSCULAR

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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

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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	Start Trial	Start Trial	Y			Start Trial
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Dr Reddys	TESTOSTERONE	testosterone	INJECTABLE;INJECTION	086417-001	Jul 7, 1983		DISCN	No	No	Start Trial	Start Trial				Start Trial
Abbvie	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Pharmacia And Upjohn	DEPO-TESTOSTERONE	testosterone cypionate	INJECTABLE;INJECTION	085635-001	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

Expired US Patents for testosterone

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993	Start Trial	Start Trial
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993	Start Trial	Start Trial
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	Start Trial	Start Trial
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	Start Trial	Start Trial
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	Start Trial	Start 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
China	102357098	Start Trial
Poland	205279	Start Trial
Japan	2004500317	Start Trial
Poland	219338	Start Trial
Austria	429920	Start Trial
>Country	>Patent Number	>Estimated Expiration

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