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JATENZO Drug Profile

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When do Jatenzo patents expire, and when can generic versions of Jatenzo launch?

Jatenzo is a drug marketed by Clarus and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-four patent family members in nine countries.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

Summary for JATENZO

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	46
Clinical Trials:	1
Patent Applications:	764
Formulation / Manufacturing:	see details
DailyMed Link:	JATENZO at DailyMed

Recent Clinical Trials for JATENZO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Clarus Therapeutics, Inc.	Phase 1
Celerion; Syneos Health; ARUP Laboratories	Phase 1

See all JATENZO clinical trials

Pharmacology for JATENZO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Synonyms for JATENZO

(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

LS-148824

MFCD00468114

Nebido

Nebido-R

Org 538

ORG-538

Pantestone

Reandron 1000

Restandol

Rextoro

SC-16124

SCHEMBL147620

T undecanoate

Testosterone (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 JATENZO

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	206089-001	Mar 27, 2019		RX	Yes	No			Y
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
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No			Y
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No			Y

International Patents for JATENZO

Country	Patent Number	Estimated Expiration
Japan	2013121986
South Korea	101432466
Canada	2604943
Japan	6251713
Japan	5887044
Australia	2011201422
South Korea	20130119518