JATENZO Drug Patent Profile
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When do Jatenzo patents expire, 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. Six 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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Questions you can ask:
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Summary for JATENZO
| International Patents: | 29 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,450 |
| Drug Prices: | Drug price information for JATENZO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JATENZO |
| What excipients (inactive ingredients) are in JATENZO? | JATENZO excipients list |
| DailyMed Link: | JATENZO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JATENZO
*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 |
Pharmacology for JATENZO
| Drug Class | Androgen |
| Mechanism of Action | Androgen 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 | |||
| >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: ⤷ Sign Up
Patent: 11201422
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0607549
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 04943
Estimated Expiration: ⤷ Sign Up
China
Patent: 1217963
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 85026
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 71384
Estimated Expiration: ⤷ Sign Up
Patent: 79699
Estimated Expiration: ⤷ Sign Up
Patent: 85026
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
Estimated Expiration: ⤷ Sign Up
Patent: 16074677
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 85026
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 85026
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 29850
Estimated Expiration: ⤷ Sign Up
Patent: 23206
Estimated Expiration: ⤷ Sign Up
Patent: 07142204
Estimated Expiration: ⤷ Sign Up
Patent: 11119796
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1382725
Estimated Expiration: ⤷ Sign Up
Patent: 1432466
Estimated Expiration: ⤷ Sign Up
Patent: 080009201
Estimated Expiration: ⤷ Sign Up
Patent: 130119518
Estimated Expiration: ⤷ Sign Up
Patent: 130124414
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.
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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