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Testosterone - Generic Drug Details

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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, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Nexus Pharms, Bel Mar, Elkins Sinn, Lilly, and Endo Pharms Inc, and is included in fifty-five 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-five 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:	379
US Patents:	41
Tradenames:	18
Applicants:	31
NDAs:	55
Drug Master File Entries:	65
Suppliers / Packagers:	17
Bulk Api Vendors:	65
Clinical Trials:	763
Patent Applications:	7,263
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for testosterone
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
		30MG/1.5ML	SOLUTION;TOPICAL

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
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	Yes					Y
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	Yes			Y
Abbvie	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes
Elkins Sinn	TESTOSTERONE PROPIONATE	testosterone propionate	INJECTABLE;INJECTION	080276-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	AB2	RX	Yes	No
Abbvie	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes					Y
Abbvie	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	AB2	RX	Yes	No					Y

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Expired US Patents for testosterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-001	Oct 12, 1993
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Auxilium Pharms Llc	STRIANT	testosterone	TABLET, EXTENDED RELEASE;BUCCAL	021543-001	Jun 19, 2003
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997
Allergan Sales Llc	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995
Alza	TESTODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	019762-002	Oct 12, 1993

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.

Patent No.	Title	Estimated Patent Expiration
2,014,073,618
9,238,072	Controlled release delivery system for nasal applications and method of treatment
9,579,280	Controlled release delivery system for nasal applications and method of treatment
2,004,092,494
7,157,097	Penetration enhancing and irritation reducing systems
8,177,449	Spreading implement
8,357,393	Transdermal delivery rate control using amorphous pharmaceutical compositions

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International Patents for testosterone

Country	Document Number	Estimated Expiration
Morocco	24964
China	102091079
Poland	366037
Poland	366117
Brazil	9812134
Poland	373593
World Intellectual Property Organization (WIPO)	2004037173