➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Baxter
McKesson
Express Scripts
Medtronic

Last Updated: March 1, 2021

DrugPatentWatch Database Preview

Rivaroxaban - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for rivaroxaban and what is the scope of freedom to operate?

Rivaroxaban is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. There are six 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
Taizhou Enze HospitalN/A
The Central Hospital of Lishui CityN/A
Boston Scientific CorporationN/A

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 022406-001 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 Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for rivaroxaban

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

Supplementary Protection Certificates for rivaroxaban

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261606 361 Finland   Start Trial
1261606 08C0051 France   Start Trial PRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
1261606 CA 2008 00050 Denmark   Start Trial PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Dow
Baxter
McKesson
McKinsey

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.