JATENZO Drug Patent Profile

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 seven 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. Three suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Jatenzo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JATENZO

International Patents:	24
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	4
Patent Applications:	1,703
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JATENZO
What excipients (inactive ingredients) are in JATENZO?	JATENZO excipients list
DailyMed Link:	JATENZO at DailyMed

See drug prices for JATENZO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for JATENZO

NDA:

206089

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JATENZO

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

Sponsor	Phase
St. Louis University	Phase 2
Clarus Therapeutics	Phase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2

See all JATENZO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for JATENZO

G03BA	3-oxoandrosten (4) derivatives
G03B	ANDROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for JATENZO

JATENZO is protected by seven US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting JATENZO

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

International Patents for JATENZO

When does loss-of-exclusivity occur for JATENZO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Japan

Russian Federation

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JATENZO around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2429850	ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC THERAPEUTIC AGENTS AND COMPOSITIONS CONTAINING IT)
Japan	5887044
Russian Federation	2011119796	ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ
Australia	2011201422	Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
South Korea	101432466
Japan	5778705
Japan	2016074677	疎水性薬物のドラッグデリバリーシステムとその組成物 (DRUG DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS THEREOF)