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Last Updated: October 5, 2024

Details for New Drug Application (NDA): 022406


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NDA 022406 describes XARELTO, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from four suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XARELTO profile page.

The generic ingredient in XARELTO is rivaroxaban. There are thirty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 022406
Tradename:XARELTO
Applicant:Janssen Pharms
Ingredient:rivaroxaban
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022406
Generic Entry Date for 022406*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 022406
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for 022406
Suppliers and Packaging for NDA: 022406
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XARELTO rivaroxaban TABLET;ORAL 022406 NDA A-S Medication Solutions 50090-3625 50090-3625-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0)
XARELTO rivaroxaban TABLET;ORAL 022406 NDA A-S Medication Solutions 50090-3625 50090-3625-1 12 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 1, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 23, 2024
Regulatory Exclusivity Use:INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
Regulatory Exclusivity Expiration:Feb 23, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Sign UpPatent Expiration:Feb 28, 2025Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022406

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.