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Last Updated: March 28, 2024

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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. Five 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
Drug patent expirations by year for KYZATREX
Drug Prices for KYZATREX

See drug prices for KYZATREX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KYZATREX
Generic Entry Date for KYZATREX*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
NDA:
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.

Pharmacology for KYZATREX
Drug ClassAndrogen
Mechanism of ActionAndrogen 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 ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY

FDA Regulatory Exclusivity protecting KYZATREX

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Marius Pharms Llc KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-002 Jul 27, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Marius Pharms Llc KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-001 Jul 27, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Marius Pharms Llc KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-003 Jul 27, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Marius Pharms Llc KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-002 Jul 27, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Marius Pharms Llc KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-003 Jul 27, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Marius Pharms Llc KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-001 Jul 27, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2012092202 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2014143127 ⤷  Try a Trial
Poland 2519230 ⤷  Try a Trial
Taiwan I673068 ⤷  Try a Trial
Portugal 2519230 ⤷  Try a Trial
China 105188670 Emulsion formulations ⤷  Try a Trial
European Patent Office 2519230 MODULATION DE LA SOLUBILITÉ, DE LA STABILITÉ, DE L'ABSORPTION, DU MÉTABOLISME ET DU PROFIL PHARMACOCINÉTIQUE DE MÉDICAMENTS LIPOPHILES PAR LES STÉROLS (MODULATION OF SOLUBILITY, STABILITY, ABSORPTION, METABOLISM, AND PHARMACOKINETIC PROFILE OF LIPOPHILIC DRUGS BY STEROLS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.