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 sixteen 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:	16
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	49
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
Clarus Therapeutics	Phase 4

See all testosterone undecanoate clinical trials

Generic filers with tentative approvals for TESTOSTERONE UNDECANOATE

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	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

Anatomical Therapeutic Chemical (ATC) Classes for testosterone undecanoate

G03BA	3-oxoandrosten (4) derivatives
G03B	ANDROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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
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
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	Y		See Plans and Pricing
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Clarus	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No	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

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Country	Patent Number	Title	Estimated Expiration
Mexico	2011007351	COMPOSICIONES ESTEROIDALES. (STEROIDAL COMPOSITIONS.)	See Plans and Pricing
Japan	2016514706	経口送達用リポバランス長鎖テストステロンエステル	See Plans and Pricing
Costa Rica	7999	METODOS Y COMPOSICIONES FARMACEUTICAS PARA LA OBTENCION CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO	See Plans and Pricing
South Korea	20080096717	METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS	See Plans and Pricing
Russian Federation	2015128028	ДЛИННОЦЕПОЧЕЧНЫЕ ЛИПОСБАЛАНСИРОВАННЫЕ СЛОЖНЫЕ ЭФИРЫ ТЕСТОСТЕРОНА ДЛЯ ПЕРОРАЛЬНОЙ ДОСТАВКИ	See Plans and Pricing
Japan	2015120700	ステロイド組成物 (STEROIDAL COMPOSITIONS)	See Plans and Pricing
Argentina	043603	COMPOSICIONES INYECTABLES PARA USO INTRAMUSCULAR CONTENIENDO ESTERES DE TESTOSTERONA Y UN VEHICULO QUE COMPRENDE ACEITE DE RICINO Y UN COSOLVENTE	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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