TESTOSTERONE UNDECANOATE - Generic Drug Details
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What are the generic sources for testosterone undecanoate and what is the scope of patent protection?
Testosterone undecanoate
is the generic ingredient in four branded drugs marketed by Tolmar, Marius Pharms Llc, Verity, and Endo Operations, and is included in four NDAs. There are twenty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Testosterone undecanoate has one hundred and thirty-seven patent family members in thirty-nine countries.
There are seven drug master file entries for testosterone undecanoate. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for TESTOSTERONE UNDECANOATE
International Patents: | 137 |
US Patents: | 29 |
Tradenames: | 4 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 59 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TESTOSTERONE UNDECANOATE
Generic Entry Dates for TESTOSTERONE UNDECANOATE*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for TESTOSTERONE UNDECANOATE*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRAMUSCULAR |
Generic Entry Dates for TESTOSTERONE UNDECANOATE*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
CAPSULE;ORAL |
Generic Entry Dates for TESTOSTERONE UNDECANOATE*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT 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 TESTOSTERONE UNDECANOATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Morten Hostrup, PhD | N/A |
Norwegian School of Sport Sciences | Phase 2/Phase 3 |
Oslo University Hospital | Phase 2/Phase 3 |
Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 750MG/3ML (250MG/ML) | INJECTABLE;INTRAMUSCULAR |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for TESTOSTERONE UNDECANOATE
Paragraph IV (Patent) Challenges for TESTOSTERONE UNDECANOATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AVEED | Injection | testosterone undecanoate | 250 mg/mL | 022219 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-002 | Mar 27, 2019 | RX | Yes | No | 11,179,403 | ⤷ Subscribe | ⤷ Subscribe | ||||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-002 | Mar 27, 2019 | RX | Yes | No | 11,564,933 | ⤷ Subscribe | ⤷ Subscribe | ||||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-001 | Mar 27, 2019 | RX | Yes | No | 11,564,933 | ⤷ Subscribe | ⤷ Subscribe | ||||
Tolmar | JATENZO | testosterone undecanoate | CAPSULE;ORAL | 206089-003 | Mar 27, 2019 | RX | Yes | Yes | 8,241,664 | ⤷ Subscribe | Y | ⤷ 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 TESTOSTERONE UNDECANOATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | PI1007025 | composições esteroidais | ⤷ Subscribe |
Russian Federation | 2007142204 | ⤷ Subscribe | |
China | 101884639 | Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels | ⤷ Subscribe |
European Patent Office | 2979699 | SYSTÈMES D'ADMINISTRATION PHARMACEUTIQUE POUR DES MÉDICAMENTS HYDROPHOBES ET LEURS COMPOSITIONS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
TESTOSTERONE UNDECANOATE Market Analysis and Financial Projection Experimental
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