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Last Updated: March 7, 2021

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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
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 Department of DefensePhase 4
University of ArkansasPhase 4

See all testosterone undecanoate clinical trials

Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial750MG/3ML (250MG/ML)INJECTABLE;INTRAMUSCULAR
  Start Trial  Start TrialUNKNOWNUNKNOWN

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   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
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
>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:

Harvard Business School
Express Scripts
Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
Dow

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