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Last Updated: July 27, 2021

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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 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.

Recent Clinical Trials for TESTOSTERONE UNDECANOATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Stone Research Foundation for Sports Medicine and ArthritisPhase 2/Phase 3
United States Army Research Institute of Environmental MedicinePhase 4
Pennington Biomedical Research CenterPhase 4

See all TESTOSTERONE UNDECANOATE clinical trials

Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free750MG/3ML (250MG/ML)INJECTABLE;INTRAMUSCULAR
⤷  Try it Free⤷  Try it FreeUNKNOWNUNKNOWN

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 ClassAndrogen
Mechanism of ActionAndrogen 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Mallinckrodt
Merck
AstraZeneca
Harvard Business School

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