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. Four 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 is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for JATENZO
| International Patents: | 29 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 51 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,540 |
| Formulation / Manufacturing: | see details |
| 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
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
| Sponsor | Phase |
|---|---|
| St. Louis University | Phase 2 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 |
| Clarus Therapeutics | Phase 2 |
Pharmacology for JATENZO
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for JATENZO
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 |
|---|---|---|---|
| Japan | 6251713 | ⤷ Try a Trial | |
| Japan | 2008537960 | ⤷ Try a Trial | |
| Poland | 2985026 | ⤷ Try a Trial | |
| Japan | 5778705 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
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