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. 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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for JATENZO?
- What are the global sales for JATENZO?
- What is Average Wholesale Price for JATENZO?
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: | 1,370 |
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 |
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 ⤷ Try for Free.
This potential generic entry date is based on patent 11,179,402.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 11,179,402 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | 8,778,916 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-001 | Mar 27, 2019 | RX | Yes | No | 8,492,369 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-002 | Mar 27, 2019 | RX | Yes | No | 11,179,402 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | 11,179,403 | ⤷ Try for Free | ⤷ Try for Free | ||||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-001 | Mar 27, 2019 | RX | Yes | No | 11,426,416 | ⤷ Try for Free | ⤷ Try for Free | ||||
>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:
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: ⤷ Try for Free
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 |
---|---|---|---|
South Korea | 101432466 | ⤷ Try for Free | |
China | 101217963 | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same | ⤷ Try for Free |
Portugal | 2985026 | ⤷ Try for Free | |
South Korea | 20080009201 | PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME | ⤷ Try for Free |
Canada | 2604943 | 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) | ⤷ Try for Free |
South Korea | 20130119518 | PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for JATENZO
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