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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Chinese Patent Office
Express Scripts
Cipla
Julphar
Covington
Farmers Insurance
McKesson
Daiichi Sankyo

Generated: April 25, 2018

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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 rivaroxaban 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-three patent family members in forty-seven countries.

There are thirty-four drug master file entries for rivaroxaban. Two suppliers are listed for this compound.
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-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]-1,3-OXAZOLIDIN-5-YL]METHYL]-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-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
D0KG3R
DB06228
EN002023
EX-A206
FT-0650700
GTPL6388
HE338716
HSDB 8149
HY-50903
J10374
KGFYHTZWPPHNLQ-AWEZNQCLSA-N
MFCD11974010
MLS006010027
MolPort-003-850-195
PB15001
Q-102503
QCR-276
RIV
Rivaroxaban (JAN/USAN/INN)
Rivaroxaban [USAN:INN:BAN:JAN]
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

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

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Non-Orange Book US Patents for rivaroxaban

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,402,851 Process for the preparation of a solid, orally administrable pharmaceutical composition ➤ Try a Free Trial
8,530,505 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Try a Free Trial
8,822,458 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Try a Free Trial
7,576,111 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for rivaroxaban

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB09/008 United Kingdom ➤ Try a Free 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.
2008018 Lithuania ➤ Try a Free Trial PRODUCT NAME: RIVARAXABANUM ; REGISTER NUMBER AND DATE: EU/1/08/472/001 20080930
0370 Netherlands ➤ Try a Free Trial
08/030 Ireland ➤ Try a Free Trial PRODUCT NAME: RIVAROXABAN AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS, HYDRATES, HYDRATES OF THE SALTS AND PRODRUGS.; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Citi
QuintilesIMS
Dow
UBS
Julphar
Moodys
McKinsey
US Army

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