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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 one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XARELTO profile page.

The generic ingredient in XARELTO is rivaroxaban. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

Summary for NDA: 022406

Tradename:
XARELTO
Applicant:
Janssen Pharms
Ingredient:
rivaroxaban
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 022406

Mechanism of ActionFactor 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 Janssen Pharmaceuticals, Inc. 50458-580 50458-580-10 10 BLISTER PACK in 1 CARTON (50458-580-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
XARELTO
rivaroxaban
TABLET;ORAL 022406 NDA Janssen Pharmaceuticals, Inc. 50458-580 50458-580-30 30 TABLET, FILM COATED in 1 BOTTLE (50458-580-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 1, 2011TE:RLD:No
Patent:7,585,860Patent Expiration:Dec 11, 2020Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jul 1, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,592,339Patent Expiration:Dec 11, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)


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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 verifification 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.

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