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Last Updated: March 28, 2024

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JATENZO Drug Patent Profile


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Which patents cover Jatenzo, and what generic alternatives are available?

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

See drug prices for JATENZO

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

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

Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 11201422
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0607549
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 04943
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1217963
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 85026
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 71384
Estimated Expiration: ⤷  Try a Trial

Patent: 79699
Estimated Expiration: ⤷  Try a Trial

Patent: 85026
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 61300
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 78705
Estimated Expiration: ⤷  Try a Trial

Patent: 87044
Estimated Expiration: ⤷  Try a Trial

Patent: 51713
Estimated Expiration: ⤷  Try a Trial

Patent: 08537960
Estimated Expiration: ⤷  Try a Trial

Patent: 13121986
Estimated Expiration: ⤷  Try a Trial

Patent: 16074677
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 85026
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 85026
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 29850
Estimated Expiration: ⤷  Try a Trial

Patent: 23206
Estimated Expiration: ⤷  Try a Trial

Patent: 07142204
Estimated Expiration: ⤷  Try a Trial

Patent: 11119796
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1382725
Estimated Expiration: ⤷  Try a Trial

Patent: 1432466
Estimated Expiration: ⤷  Try a Trial

Patent: 080009201
Estimated Expiration: ⤷  Try a Trial

Patent: 130119518
Estimated Expiration: ⤷  Try a Trial

Patent: 130124414
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 30658
Estimated Expiration: ⤷  Try a Trial

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
Portugal 2985026 ⤷  Try a Trial
South Korea 20080009201 PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME ⤷  Try a Trial
South Korea 20130124414 PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME ⤷  Try a Trial
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) ⤷  Try a Trial
>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.