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Last Updated: May 8, 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.

Summary for testosterone undecanoate

International Patents:	137
US Patents:	28
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	56
Formulation / Manufacturing:	see details
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CAPSULE;ORAL
Generic Entry Dates for testosterone undecanoate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: INJECTABLE;INTRAMUSCULAR
Generic Entry Dates for testosterone undecanoate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: NEW PRODUCT Dosage: CAPSULE;ORAL
Generic Entry Dates for testosterone undecanoate^: ⤷ Try a Trial* 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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2
Clarus Therapeutics	Phase 2
University of Miami	Phase 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 Trial	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

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

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Glossary

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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	Y			⤷ 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
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	206089-001	Mar 27, 2019		RX	Yes	No	⤷ 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	Y	Y		⤷ Try a Trial
Endo Pharms Inc	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3797762	ESTERS DE TESTOSTÉRONE À LONGUE CHAÎNE LIPOÉQUILIBRÉS POUR UNE ADMINISTRATION ORALE (LIPOBALANCED LONG CHAIN TESTOSTERONE ESTERS FOR ORAL DELIVERY)	⤷ Try a Trial
Japan	2013177454	MODULATION OF SOLUBILITY, STABILITY, ABSORPTION, METABOLISM AND PHARMACOKINETIC PROFILE OF LIPOPHILIC DRUG BY STEROL	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2004080383		⤷ Try a Trial
Australia	2006236564	Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same	⤷ Try a Trial
Jordan	2505	طرق و تركيبات صيدلية للحصول على مستويات تستوستيرون مصلي مقبولة (method and pharmaceutical compositions for reliable achievements of acceptable serum testosterone levels)	⤷ Try a Trial
Spain	2930658		⤷ Try a Trial
Russian Federation	2015128028	ДЛИННОЦЕПОЧЕЧНЫЕ ЛИПОСБАЛАНСИРОВАННЫЕ СЛОЖНЫЕ ЭФИРЫ ТЕСТОСТЕРОНА ДЛЯ ПЕРОРАЛЬНОЙ ДОСТАВКИ	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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