Testosterone undecanoate - Generic Drug Details

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.

Summary for testosterone undecanoate

International Patents:	109
US Patents:	18
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	56
Patent Applications:	2,523
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

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
		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

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
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes			Y	Y
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes			Y
Antares Pharma Inc	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes			Y

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
Portugal	1457208
South Korea	20050109561	METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS
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.
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)
Brazil	112015020849	ésteres de testosterona de cadeia longa lipobalanceados para entrega oral