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Last Updated: May 26, 2022

JATENZO Drug Patent 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 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

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Summary for JATENZO
Drug patent expirations by year for JATENZO
Drug Prices for JATENZO

See drug prices for JATENZO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for JATENZO
Generic Entry Date for JATENZO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
St. Louis UniversityPhase 2
Clarus TherapeuticsPhase 2
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2

See all JATENZO clinical trials

US Patents and Regulatory Information for JATENZO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JATENZO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting JATENZO

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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

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

Patent: 06236564
Estimated Expiration: See Plans and Pricing

Patent: 11201422
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0607549
Estimated Expiration: See Plans and Pricing

Canada

Patent: 04943
Estimated Expiration: See Plans and Pricing

China

Patent: 1217963
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 71384
Estimated Expiration: See Plans and Pricing

Patent: 79699
Estimated Expiration: See Plans and Pricing

Patent: 85026
Estimated Expiration: See Plans and Pricing

Japan

Patent: 78705
Estimated Expiration: See Plans and Pricing

Patent: 87044
Estimated Expiration: See Plans and Pricing

Patent: 51713
Estimated Expiration: See Plans and Pricing

Patent: 08537960
Estimated Expiration: See Plans and Pricing

Patent: 13121986
Estimated Expiration: See Plans and Pricing

Patent: 16074677
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 29850
Estimated Expiration: See Plans and Pricing

Patent: 23206
Estimated Expiration: See Plans and Pricing

Patent: 07142204
Estimated Expiration: See Plans and Pricing

Patent: 11119796
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1382725
Estimated Expiration: See Plans and Pricing

Patent: 1432466
Estimated Expiration: See Plans and Pricing

Patent: 080009201
Estimated Expiration: See Plans and Pricing

Patent: 130119518
Estimated Expiration: See Plans and Pricing

Patent: 130124414
Estimated Expiration: See Plans and Pricing

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) See Plans and Pricing
Japan 5887044 See Plans and Pricing
Russian Federation 2011119796 ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ See Plans and Pricing
Australia 2011201422 Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same See Plans and Pricing
South Korea 101432466 See Plans and Pricing
Japan 5778705 See Plans and Pricing
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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Express Scripts
Johnson and Johnson
Dow
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.