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Last Updated: April 13, 2024

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 four branded drugs marketed by Tolmar, Marius Pharms Llc, Verity, and Endo Pharms Inc, and is included in four NDAs. There are twenty-eight 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. Five suppliers are listed for this compound. There is one tentative approval for this compound.

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

SponsorPhase
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
Clarus TherapeuticsPhase 2
Clarus TherapeuticsPhase 4

See all testosterone undecanoate clinical trials

Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial750MG/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 ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
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
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 Title Estimated Expiration
Taiwan 201521731 Lipobalanced long chain testosterone esters for oral delivery ⤷  Try a Trial
Ecuador SP056095 MÉTODOS Y COMPOSICIONES FARMACÉUTICAS PARA LA OBTENCIÓN CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO ⤷  Try a Trial
Costa Rica 7999 METODOS Y COMPOSICIONES FARMACEUTICAS PARA LA OBTENCION CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO ⤷  Try a Trial
Slovenia 1457208 ⤷  Try a Trial
>Country >Patent Number >Title >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.