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Last Updated: October 7, 2024

Details for New Drug Application (NDA): 215859


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NDA 215859 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 215859
Tradename:XARELTO
Applicant:Janssen Pharms
Ingredient:rivaroxaban
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215859
Generic Entry Date for 215859*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;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: 215859
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for 215859
Suppliers and Packaging for NDA: 215859
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XARELTO rivaroxaban FOR SUSPENSION;ORAL 215859 NDA Janssen Pharmaceuticals, Inc. 50458-575 50458-575-01 1 BOTTLE in 1 CARTON (50458-575-01) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength1MG/ML
Approval Date:Dec 20, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 20, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jun 20, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Sign UpPatent Expiration:Feb 28, 2025Product Flag?Substance Flag?Delist Request?Y

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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.