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
Summary for KYZATREX
International Patents: | 20 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Patent Applications: | 1,540 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for KYZATREX |
What excipients (inactive ingredients) are in KYZATREX? | KYZATREX excipients list |
DailyMed Link: | KYZATREX at DailyMed |
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 Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for KYZATREX
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
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 |