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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 Action	Factor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for 022406

Factor Xa Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jul 1, 2011	TE:		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 Up	Patent Expiration:	Feb 28, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022406

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

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