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Last Updated: November 30, 2020

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Rivaroxaban - Generic Drug Details

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What are the generic sources for rivaroxaban and what is the scope of patent protection?

Rivaroxaban is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rivaroxaban has one hundred and fifty-six patent family members in forty-seven countries.

There are thirty-five drug master file entries for rivaroxaban. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for rivaroxaban

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Canisius-Wilhelmina HospitalPhase 4
Academisch Ziekenhuis GroningenPhase 4
Rijnstate HospitalPhase 4

See all rivaroxaban clinical trials

Generic filers with tentative approvals for RIVAROXABAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial20MGTABLET;ORAL
  Start Trial  Start Trial15MGTABLET;ORAL
  Start Trial  Start Trial10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for rivaroxaban
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for rivaroxaban
Paragraph IV (Patent) Challenges for RIVAROXABAN
Tradename Dosage Ingredient NDA Submissiondate
XARELTO TABLET;ORAL rivaroxaban 022406 2018-11-19
XARELTO TABLET;ORAL rivaroxaban 022406 2015-07-01

US Patents and Regulatory Information for rivaroxaban

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for rivaroxaban

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261606 C 2008 019 Romania   Start Trial PRODUCT NAME: 5-CLORO-N-({(5S)-2-OXO-3-[4-(3-OXO-4-MORFOLINIL)FENIL]-1,3-OXAZOLIDIN-5-IL}-METIL)-2TIOFENCARBOXAMIDA - RIVAROXABAN; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/472/001, RO EU/1/08/472/002, RO EU/1/08/472/003, RO EU/1/08/472/004, RO EU/1/08/472/005, RO EU/1/08/472/006, RO EU/1/08/472/007, RO EU/1/08/472/008; DATE OF NATIONAL AUTHORISATION: 20080930; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/08/472/001, EMEA EU/1/08/472/002, EMEA EU/1/08/472/003, EMEA EU/1/08/472/004, EMEA EU/1/08/472/005, EMEA EU/1/08/472/006, EMEA EU/1/08/472/007, EMEA EU/1/08/472/008; DATE OF FIRST AUTHORISATION IN EEA: 20080930
1261606 2008C/046 Belgium   Start Trial PRODUCT NAME: RIVAROXABAN; AUTHORISATION NUMBER AND DATE: EU/1/08/472/001
1261606 300370 Netherlands   Start Trial
1261606 SPC/GB09/008 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/008 GRANTED TO BAYER INTELLECTUAL PROPERTY GMBH IN RESPECT OF THE PRODUCT RIVAROXABAN AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS, HYDRATES, HYDRATES OF THE SALTS AND PRODRUGS, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6352 DATED 16 FEBRUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 OCTOBER 2023.
1261606 08C0051 France   Start Trial PRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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