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Last Updated: December 12, 2024

Details for New Drug Application (NDA): 213953


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NDA 213953 describes KYZATREX, which is a drug marketed by Marius Pharms Llc and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the KYZATREX profile page.

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.
Summary for 213953
Tradename:KYZATREX
Applicant:Marius Pharms Llc
Ingredient:testosterone undecanoate
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213953
Generic Entry Date for 213953*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
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 NDA: 213953
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 213953
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KYZATREX testosterone undecanoate CAPSULE;ORAL 213953 NDA AUTHORIZED GENERIC Trifluent Pharma LLC 73352-105 73352-105-22 120 CAPSULE in 1 BOTTLE (73352-105-22)
KYZATREX testosterone undecanoate CAPSULE;ORAL 213953 NDA Marius Pharmaceuticals 80603-101 80603-101-11 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 27, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Dec 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING TESTOSTERONE DEFICIENCY
Patent:⤷  Sign UpPatent Expiration:Dec 31, 2030Product Flag?YSubstance Flag?Delist Request?

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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.