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Last Updated: December 14, 2019

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XARELTO Drug Profile

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When do Xarelto patents expire, and when can generic versions of Xarelto launch?

Xarelto is a drug marketed by Janssen Pharms and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fifty-four patent family members in forty-seven countries.

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

US ANDA Litigation and Generic Entry Outlook for Xarelto

Xarelto was eligible for patent challenges on July 1st, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 13th, 2024. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $3.5bn, indicating a strong incentive for generic entry (peak sales were $3.6bn in 2016).

There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

There is one tentative approval for the generic drug (rivaroxaban), which indicates the potential for near-term generic launch.

Drug patent expirations by year for XARELTO
Drug Prices for XARELTO

See drug prices for XARELTO

Drug Sales Revenue Trends for XARELTO

See drug sales revenues for XARELTO

Generic Entry Opportunity Date for XARELTO
Generic Entry Date for XARELTO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XARELTO

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

SponsorPhase
George Clinical Pty LtdPhase 3
The George InstitutePhase 3
Orthopaedic Trauma AssociationPhase 4

See all XARELTO clinical trials

Recent Litigation for XARELTO

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 XARELTO litigation

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

See all XARELTO litigation

Pharmacology for XARELTO
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Synonyms for XARELTO
(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
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 (TN)
ZINC3964126
Paragraph IV (Patent) Challenges for XARELTO
Tradename Dosage Ingredient NDA Submissiondate
XARELTO TABLET;ORAL rivaroxaban 022406 2018-11-19

US Patents and Regulatory Information for XARELTO

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 022406-003 Nov 4, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 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   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 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 XARELTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261606 2008C/046 Belgium   Start Trial PRODUCT NAME: RIVAROXABAN; AUTHORISATION NUMBER AND DATE: EU/1/08/472/001
1261606 48/2008 Austria   Start Trial PRODUCT NAME: RIVAROXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/08/472/001 - EU/1/08/472/008 20080930
1261606 CA 2008 00050 Denmark   Start Trial PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS
1261606 300370 Netherlands   Start Trial
1261606 C01261606/01 Switzerland   Start Trial FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Merck
Moodys
Johnson and Johnson

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.