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
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Questions you can ask:
- What is the 5 year forecast for JATENZO?
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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: | 1,479 |
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 |
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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
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 | 206089-001 | Mar 27, 2019 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-002 | Mar 27, 2019 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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: ⤷ Subscribe
Patent: 11201422
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0607549
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 04943
Estimated Expiration: ⤷ Subscribe
China
Patent: 1217963
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 85026
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 71384
Estimated Expiration: ⤷ Subscribe
Patent: 79699
Estimated Expiration: ⤷ Subscribe
Patent: 85026
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 61300
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 78705
Estimated Expiration: ⤷ Subscribe
Patent: 87044
Estimated Expiration: ⤷ Subscribe
Patent: 51713
Estimated Expiration: ⤷ Subscribe
Patent: 08537960
Estimated Expiration: ⤷ Subscribe
Patent: 13121986
Estimated Expiration: ⤷ Subscribe
Patent: 16074677
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 85026
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 85026
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 29850
Estimated Expiration: ⤷ Subscribe
Patent: 23206
Estimated Expiration: ⤷ Subscribe
Patent: 07142204
Estimated Expiration: ⤷ Subscribe
Patent: 11119796
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1382725
Estimated Expiration: ⤷ Subscribe
Patent: 1432466
Estimated Expiration: ⤷ Subscribe
Patent: 080009201
Estimated Expiration: ⤷ Subscribe
Patent: 130119518
Estimated Expiration: ⤷ Subscribe
Patent: 130124414
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 30658
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Australia | 2006236564 | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same | ⤷ Subscribe |
Canada | 2604943 | ⤷ Subscribe | |
Japan | 2008537960 | ⤷ Subscribe | |
Russian Federation | 2429850 | ФАРМАЦЕВТИЧЕСКИЕ СИСТЕМЫ ДОСТАВКИ ДЛЯ ГИДРОФОБНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ И КОМПОЗИЦИЙ, ИХ СОДЕРЖАЩИХ (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC THERAPEUTIC AGENTS AND COMPOSITIONS CONTAINING IT) | ⤷ Subscribe |
World Intellectual Property Organization (WIPO) | 2006113505 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
JATENZO Market Analysis and Financial Projection
More… ↓