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kyzatrex Drug Patent Profile

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

Kyzatrex is a drug marketed by Marius Pharms Llc and is included in one NDA. There are four 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. Six 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 July 27, 2025. 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

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Summary for kyzatrex

International Patents:	20
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	1
Patent Applications:	1,450
Drug Prices:	Drug price information for kyzatrex
What excipients (inactive ingredients) are in kyzatrex?	kyzatrex excipients list
DailyMed Link:	kyzatrex at DailyMed

Drug patent expirations by year for kyzatrex

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

Generic Entry Date for kyzatrex^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW PRODUCT 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 four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of kyzatrex is ⤷ Sign Up.

This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting kyzatrex

Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

FDA Regulatory Exclusivity protecting kyzatrex

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up

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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
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-001	Jul 27, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-002	Jul 27, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-001	Jul 27, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-003	Jul 27, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-002	Jul 27, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Marius Pharms Llc	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-003	Jul 27, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 kyzatrex

See the table below for patents covering kyzatrex around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	5836322		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012092202		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011082384		⤷ Sign Up
Japan	2013516433		⤷ Sign Up
China	105188670	Emulsion formulations	⤷ Sign Up
Portugal	2519230		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration