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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206089


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NDA 206089 describes JATENZO, which is a drug marketed by Clarus and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the JATENZO profile page.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
Summary for 206089
Tradename:JATENZO
Applicant:Clarus
Ingredient:testosterone undecanoate
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 206089
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 206089
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JATENZO testosterone undecanoate CAPSULE;ORAL 206089 NDA Clarus Therapeutics, Inc. 69087-158 69087-158-12 12 BOTTLE, PLASTIC in 1 BOX (69087-158-12) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
JATENZO testosterone undecanoate CAPSULE;ORAL 206089 NDA Clarus Therapeutics, Inc. 69087-198 69087-198-12 12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength158MG
Approval Date:Mar 27, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 27, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Apr 12, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING TESTOSTERONE DEFICIENCY
Patent:  Start TrialPatent Expiration:Apr 12, 2030Product Flag?YSubstance Flag?YDelist Request?

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