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Testosterone undecanoate - Generic Drug Details
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What are the generic drug sources for testosterone undecanoate and what is the scope of freedom to operate?
Testosterone undecanoate
is the generic ingredient in two branded drugs marketed by Clarus and Endo Pharms Inc, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Testosterone undecanoate has seventy-six patent family members in thirty-eight countries.
There are sixty-nine drug master file entries for testosterone undecanoate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for testosterone undecanoate
| International Patents: | 76 |
| US Patents: | 7 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 69 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 46 |
| Clinical Trials: | 50 |
| Patent Applications: | 1,538 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for testosterone undecanoate |
| What excipients (inactive ingredients) are in testosterone undecanoate? | testosterone undecanoate excipients list |
| DailyMed Link: | testosterone undecanoate at DailyMed |
Recent Clinical Trials for testosterone undecanoate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Stone Research Foundation for Sports Medicine and Arthritis | Phase 2/Phase 3 |
| United States Army Research Institute of Environmental Medicine | Phase 4 |
| Pennington Biomedical Research Center | Phase 4 |
Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 750MG/3ML (250MG/ML) | INJECTABLE;INTRAMUSCULAR |
| Start Trial | Start Trial | UNKNOWN | UNKNOWN |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for testosterone undecanoate
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Paragraph IV (Patent) Challenges for TESTOSTERONE UNDECANOATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AVEED | INJECTABLE;INTRAMUSCULAR | testosterone undecanoate | 022219 | 2014-06-11 |
US Patents and Regulatory Information for testosterone undecanoate
| 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 | 206089-002 | 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 | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | 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 | Y | 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 testosterone undecanoate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20130124414 | Start Trial |
| Ukraine | 82510 | Start Trial |
| European Patent Office | 1871384 | Start Trial |
| Uruguay | 28231 | Start Trial |
| Serbia | 51537 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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