Last Updated: September 24, 2026

Details for New Drug Application (NDA): 206089

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NDA 206089 describes JATENZO, which is a drug marketed by Tolmar and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the JATENZO profile page.

The generic ingredient in JATENZO is testosterone undecanoate. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

Summary for 206089

Tradename:	JATENZO
Applicant:	Tolmar
Ingredient:	testosterone undecanoate
Patents:	11

Pharmacology for NDA: 206089

Mechanism of Action	Androgen Receptor Agonists

Suppliers and Packaging for NDA: 206089

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089	NDA	TOLMAR Inc.	69087-158	69087-158-12	12 BOTTLE, PLASTIC in 1 BOX (69087-158-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089	NDA	TOLMAR Inc.	69087-198	69087-198-12	12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	158MG
Approval Date:	Mar 27, 2019	TE:		RLD:	Yes
Patent:	10,543,219	Patent Expiration:	Apr 12, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING TESTOSTERONE DEFICIENCY
Patent:	10,617,696	Patent Expiration:	Apr 12, 2030	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	11,179,402	Patent Expiration:	Apr 14, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 206089

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019	11,179,402	⤷ Start Trial
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019	11,179,402	⤷ Start Trial
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019	11,179,402	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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