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Testosterone undecanoate - Generic Drug Details

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What are the generic drug sources for testosterone undecanoate and what is the scope of testosterone undecanoate patent protection?

Testosterone undecanoate is the generic ingredient in two branded drugs marketed by Clarus and Endo Pharms Inc, and is included in two NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Testosterone undecanoate has seventy-five patent family members in thirty-seven countries.

There are sixty-nine drug master file entries for testosterone undecanoate. One supplier is listed for this compound.

Summary for testosterone undecanoate

International Patents:	75
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	69
Suppliers / Packagers:	1
Bulk Api Vendors:	46
Clinical Trials:	45
Patent Applications:	1,120
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for testosterone undecanoate
DailyMed Link:	testosterone undecanoate at DailyMed

Pharmacology for testosterone undecanoate

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Synonyms for testosterone undecanoate

(17-beta)-3-Oxoandrost-4-en-17-yl undecanoate

(17|A)-17-[(1-| xoundecyl)oxy]androst-4-en-3-one

(17beta)-3-Oxoandrost-4-en-17-yl undecanoate

(1S,2R,10R,11S,14S,15S)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl undecanoate

(1S,2R,10R,11S,14S,15S)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0?,?.0??,??]heptadec-6-en-14-yl undecanoate

[(8R,9S,10R,13S,14S,17S)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] undecanoate

17beta-Hydroxyandrost-4-en-3-one undecanoate

3-Oxoandrost-4-en-17beta-yl undecanoate

4-08-00-00981 (Beilstein Handbook Reference)

5-.alpha.-Androstan-3-one, 17-.beta.-hydroxy-, undecanoate

5-alpha-Androstan-3-one, 17-beta-hydroxy-, undecanoate

5949-44-0

949T440

AC1L22PV

AKOS016010255

AN-11881

Andriol

Andriol (TN)

Andriol Testocaps

Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17-beta)-

Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17beta)-

Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-(17beta)

Androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17.beta.)-

Aveed

BAY 86-5037

BCP11921

BRN 3176734

C-22555

CC-34823

CHEBI:135741

CHEMBL2107067

CLR-610

CS-4342

D06087

EINECS 227-712-6

GS-6598

H16A5VCT9C

HY-B0626

Jatenzo

LS-148824

MolPort-003-850-422

Nebido

Nebido-R

Org 538

ORG-538

Pantestone

Reandron 1000

Restandol

Rextoro

SC-16124

SCHEMBL147620

T undecanoate

Testosterone (undecanoate)

Testosterone undecanoate (USAN)

Testosterone undecanoate [USAN]

Testosterone Undeconate

Testosterone undecylate

Testosterone, undecanoate

Testosterone, undecanoate (ester)

UDSFVOAUHKGBEK-CNQKSJKFSA-N

Undestor

UNII-H16A5VCT9C

W-105318

ZINC8214690

US Patents and Regulatory Information for testosterone undecanoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No			Y
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No			Y
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes			Y

International Patents for testosterone undecanoate

Country	Patent Number	Estimated Expiration
Russian Federation	2007118196
Hong Kong	1069325
Canada	2518910