KYZATREX Drug Patent Profile

When do Kyzatrex patents expire, and what generic alternatives are available?

Kyzatrex is a drug marketed by Marius and is included in one NDA. There are six patents protecting this drug.

This drug has twenty patent family members in eleven countries.

The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Kyzatrex

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 31, 2030. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for KYZATREX

International Patents:	20
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	1
Drug Prices:	Drug price information for KYZATREX
What excipients (inactive ingredients) are in KYZATREX?	KYZATREX excipients list
DailyMed Link:	KYZATREX at DailyMed

See drug prices for KYZATREX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KYZATREX

NDA:

213953

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 KYZATREX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
San Diego Sexual Medicine	Phase 2

See all KYZATREX clinical trials

Pharmacology for KYZATREX

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for KYZATREX

KYZATREX is protected by six US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-001	Jul 27, 2022		DISCN	Yes	No			Y
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-003	Jul 27, 2022		RX	Yes	Yes			Y
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-002	Jul 27, 2022		RX	Yes	No			Y

International Patents for KYZATREX

When does loss-of-exclusivity occur for KYZATREX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

China

European Patent Office

Hong Kong

Japan

New Zealand

Poland

Portugal

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYZATREX around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968137
Spain	2710149
Taiwan	201444586	Emulsion formulations