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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Rivaroxaban - Generic Drug Details

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What are the generic 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 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-four 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
Odense University HospitalPhase 4
Aalborg UniversitetshospitalPhase 4
Rigshospitalet, DenmarkPhase 4

See all rivaroxaban clinical trials

Recent Litigation for rivaroxaban

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer Intellectual Property GMBH v. Teva Pharmaceuticals USA, Inc.2018-12-05
Bayer Intellectual Property GmbH v. Torrent Pharmaceuticals, Limited2017-08-18
Bayer Intellectual Property GmbH v. Breckenridge Pharmaceutical, Inc.2017-08-11

See all rivaroxaban litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2018-05-24
Mylan Pharmaceuticals Inc2016-10-07
Mylan Pharmaceuticals Inc.2016-10-07

See all rivaroxaban litigation

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
Synonyms for rivaroxaban
(S)-5-Chloro-N-((2-oxo-3-(4-(3-oxomorpholino)phenyl)-oxazolidin-5-yl)methyl )thiophene-2-carboxamide
(S)-5-Chloro-N-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide
(s)-5-chloro-n-{[2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl} thiophene-2-carboxam
2-Thiophenecarboxamide, 5-chloro-N-(((5S)-2-oxo-3-(4-(3-oxo-4-morpholinyl)phenyl)-5-oxazolidinyl)methyl)-
2-Thiophenecarboxamide, 5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-
2w26
366789-02-8
5-Chlor-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide
5-Chloro-N-(((5S)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl) phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide
5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide
5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophencarboxamide
5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophene-carboxamide
5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide
5-chloro-N-({(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl} methyl)thiophene-2-carboxamide
5-Chloro-N-({(5s)-2-Oxo-3-[4-(3-Oxomorpholin-4-Yl)phenyl]-1,3-Oxazolidin-5-Yl}methyl)thiophene-2-Carboxamide
5-CHLORO-N-[[(5S)-2-OXO-3-[4-(3-OXO-4-MORPHOLINYL)PHENYL]-5-OXAZOLIDINYL]METHYL]-2-THIOPHENECARBOXAMIDE
5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide
5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl]thiophene-2-carboxamide
5-CHLORO-N-[[(S)-3-(4-(3-OXOMORPHOLIN-4-YL)PHENYL)-2-OXO-1,3-OXAZOLIDIN-5-YL]METHYL]-THIOPHENE-2-CARBOXAMIDE
5-chloro-N-{[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl}thiophene-2-carboxamide
5-Chloro-N-{[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl}thiophene-2-carboxamide
789R028
9NDF7JZ4M3
AB0009978
AB01563270_01
ABP000227
AJ-47544
AK-72888
AKOS005145918
AMX10143
AN-420
AOB87363
API0000815
AX8157897
BAY 59-7939
BAY-59-7939
BAY59-7939
BDBM7840
BR-72888
BRD-K37130656-001-01-2
CCG-212899
CHEBI:68579
CHEMBL198362
CS-0555
D07086
DB06228
EN002023
EX-A206
FT-0650700
GTPL6388
HSDB 8149
HY-50903
J10374
KGFYHTZWPPHNLQ-AWEZNQCLSA-N
MLS006010027
MolPort-003-850-195
NCGC00379033-04
PB15001
Q-102503
QCR-276
RIV
Rivaroxaban (JAN/USAN/INN)
Rivaroxaban [USAN:INN:BAN:JAN]
Rivaroxaban, 98%
Rivaroxaban,Xarelto,BAY 59-7939
Rivaroxaban/Xarelto/
S-4924
SCHEMBL3914
SMR002529611
SR-01000944189
SR-01000944189-1
THI055
UNII-9NDF7JZ4M3
US8822458, 44
US8822458, 97
Xarelto
Xarelto (TN)
ZINC3964126
Paragraph IV (Patent) Challenges for RIVAROXABAN
Tradename Dosage Ingredient NDA Submissiondate
XARELTO TABLET;ORAL rivaroxaban 022406 2018-11-19

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 022406-001 Jul 1, 2011 RX Yes No   Start Trial   Start Trial Y 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
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 022406-004 Oct 11, 2018 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   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 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

Supplementary Protection Certificates for rivaroxaban

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261606 PA2008018 Lithuania   Start Trial PRODUCT NAME: RIVAROXABANUM; REG. NO/DATE: EU/1/07/472/001-008 20080930
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
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 361 Finland   Start Trial
1261606 2008C/046 Belgium   Start Trial PRODUCT NAME: RIVAROXABAN; AUTHORISATION NUMBER AND DATE: EU/1/08/472/001
1261606 300370 Netherlands   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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