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JATENZO Drug Profile
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» See Plans and PricingWhen do Jatenzo patents expire, and when can generic versions of Jatenzo launch?
Jatenzo is a drug marketed by Clarus and is included in one NDA. There are five patents protecting this drug.
This drug has twenty-four patent family members in nine countries.
The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
US ANDA Litigation and Generic Entry Outlook for Jatenzo
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: | 24 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 44 |
| Clinical Trials: | 1 |
| Patent Applications: | 786 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JATENZO |
| DailyMed Link: | JATENZO at DailyMed |
Recent Clinical Trials for JATENZO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clarus Therapeutics, Inc. | Phase 1 |
| Celerion; Syneos Health; ARUP Laboratories | Phase 1 |
Pharmacology for JATENZO
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
US Patents and Regulatory Information for JATENZO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clarus | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-001 | Mar 27, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Clarus | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Clarus | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-002 | Mar 27, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Clarus | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-001 | Mar 27, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Clarus | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-002 | Mar 27, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Clarus | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-002 | Mar 27, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2007142204 | Start Trial |
| China | 101217963 | Start Trial |
| Russian Federation | 2011119796 | Start Trial |
| European Patent Office | 2979699 | Start Trial |
| Canada | 2604943 | Start Trial |
| Russian Federation | 2429850 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
