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Last Updated: August 17, 2022

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 three branded drugs marketed by Clarus, Antares Pharma Inc, and Endo Pharms Inc, and is included in three NDAs. There are eighteen 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 nine patent family members in thirty-eight countries.

There are seven drug master file entries for testosterone undecanoate. Three suppliers are listed for this compound. There is one tentative approval for this compound.

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
University of MiamiPhase 4

See all testosterone undecanoate clinical trials

Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing750MG/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 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
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Antares Pharma Inc TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Eurasian Patent Organization 200501819 СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА В СЫВОРОТКЕ See Plans and Pricing
Portugal 1457208 See Plans and Pricing
South Korea 20050109561 METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS See Plans and Pricing
Chile 2004000527 COMPOSICION FARMACEUTICA PARA INYECCION INTRAMUSCULAR QUE COMPRENDE UN ESTER DE TESTOSTERONA, 25 A 45% V/V DE ACEITE DE RICINO COMO VEHICULO Y UN COSOLVENTE, FORMULACION FARMACEUTICA, Y USO. See Plans and Pricing
Canada 2604943 SYSTEMES D'APPORT DE SUBSTANCES PHARMACEUTIQUES DESTINES A DES MEDICAMENTS HYDROPHOBES ET COMPOSITIONS COMPRENANT CES DERNIERS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME) See Plans and Pricing
Brazil 112015020849 ésteres de testosterona de cadeia longa lipobalanceados para entrega oral See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Dow

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