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Last Updated: July 22, 2024

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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 Tolmar and is included in one NDA. There are ten patents protecting this drug.

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

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Five 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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for JATENZO
Drug Prices for JATENZO

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
Clarus TherapeuticsPhase 2

See all JATENZO clinical trials

Pharmacology for JATENZO
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists

US Patents and Regulatory Information for JATENZO

JATENZO is protected by ten US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JATENZO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING TESTOSTERONE DEFICIENCY IN MEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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
Patent: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Estimated Expiration: ⤷  Sign Up

Patent: 11201422
Patent: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0607549
Patent: sistemas de distribuição farmacêutica para fármacos hidrófobos e composições compreendendo os mesmos
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 04943
Patent: SYSTEMES D'APPORT DE SUBSTANCES PHARMACEUTIQUES DESTINES A DES MEDICAMENTS HYDROPHOBES ET COMPOSITIONS COMPRENANT CES DERNIERS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1217963
Patent: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 85026
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 71384
Patent: SYSTEMES D'APPORT DE SUBSTANCES PHARMACEUTIQUES DESTINES A DES MEDICAMENTS HYDROPHOBES ET COMPOSITIONS COMPRENANT CES DERNIERS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 79699
Patent: SYSTÈMES D'ADMINISTRATION PHARMACEUTIQUE POUR DES MÉDICAMENTS HYDROPHOBES ET LEURS COMPOSITIONS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 85026
Patent: SYSTEMES D'ADMINISTRATION PHARMACEUTIQUE POUR DES MEDICAMENTS HYDROPHOBES ET LEURS COMPOSITIONS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 61300
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 78705
Estimated Expiration: ⤷  Sign Up

Patent: 87044
Estimated Expiration: ⤷  Sign Up

Patent: 51713
Estimated Expiration: ⤷  Sign Up

Patent: 08537960
Estimated Expiration: ⤷  Sign Up

Patent: 13121986
Patent: PHARMACEUTICAL DELIVERY SYSTEM FOR HYDROPHOBIC DRUG AND COMPOSITION COMPRISING THE SAME
Estimated Expiration: ⤷  Sign Up

Patent: 16074677
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 85026
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 85026
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 29850
Patent: ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC THERAPEUTIC AGENTS AND COMPOSITIONS CONTAINING IT)
Estimated Expiration: ⤷  Sign Up

Patent: 23206
Patent: ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC MEDICINAL PRODUCTS AND COMPOSITIONS CONTAINING THEM)
Estimated Expiration: ⤷  Sign Up

Patent: 07142204
Patent: ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ
Estimated Expiration: ⤷  Sign Up

Patent: 11119796
Patent: ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1382725
Estimated Expiration: ⤷  Sign Up

Patent: 1432466
Estimated Expiration: ⤷  Sign Up

Patent: 080009201
Patent: PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME
Estimated Expiration: ⤷  Sign Up

Patent: 130119518
Patent: PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME
Estimated Expiration: ⤷  Sign Up

Patent: 130124414
Patent: PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 30658
Estimated Expiration: ⤷  Sign Up

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 2623206 ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC MEDICINAL PRODUCTS AND COMPOSITIONS CONTAINING THEM) ⤷  Sign Up
European Patent Office 2979699 SYSTÈMES D'ADMINISTRATION PHARMACEUTIQUE POUR DES MÉDICAMENTS HYDROPHOBES ET LEURS COMPOSITIONS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME) ⤷  Sign Up
Poland 2985026 ⤷  Sign Up
Japan 2013121986 PHARMACEUTICAL DELIVERY SYSTEM FOR HYDROPHOBIC DRUG AND COMPOSITION COMPRISING THE SAME ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.