RIVAROXABAN - Generic Drug Details

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 two NDAs. There are four 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. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for RIVAROXABAN

International Patents:	156
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	340
Patent Applications:	6,279
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RIVAROXABAN
What excipients (inactive ingredients) are in RIVAROXABAN?	RIVAROXABAN excipients list
DailyMed Link:	RIVAROXABAN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RIVAROXABAN

Dosage:

TABLET;ORAL

Dosage:

FOR SUSPENSION;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 RIVAROXABAN

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

Sponsor	Phase
China National Center for Cardiovascular Diseases	Phase 4
University Hospital, Angers	Phase 3
Zunyi Medical College	Phase 4

See all RIVAROXABAN clinical trials

Generic filers with tentative approvals for RIVAROXABAN

Applicant	Application No.	Strength	Dosage Form
		20MG	TABLET;ORAL
		15MG	TABLET;ORAL
		10MG	TABLET;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 Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for RIVAROXABAN

Factor Xa Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RIVAROXABAN

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for RIVAROXABAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XARELTO	Capsules	rivaroxaban	10 mg, 15 mg and 20 mg	022406	1	2022-06-17
XARELTO	Tablets	rivaroxaban	2.5 mg	022406	4	2018-11-19
XARELTO	Tablets	rivaroxaban	10 mg, 15 mg, and 20 mg	022406	8	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	022406-003	Nov 4, 2011		RX	Yes	Yes					Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018		RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011		RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011		RX	Yes	Yes
Janssen Pharms	XARELTO	rivaroxaban	FOR SUSPENSION;ORAL	215859-001	Dec 20, 2021		RX	Yes	Yes
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011		RX	Yes	No					Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011		RX	Yes	No					Y

Expired US Patents for RIVAROXABAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011

EU/EMA Drug Approvals for RIVAROXABAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Rivaroxaban Accord	rivaroxaban	EMEA/H/C/005279 Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients).AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.AdultsPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.	Authorised	yes	no	no	2020-11-16
Mylan Ireland Limited	Rivaroxaban Viatris (previously Rivaroxaban Mylan)	rivaroxaban	EMEA/H/C/005600 Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. ------Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.-------Adults Prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.	Authorised	yes	no	no	2021-11-12
Bayer AG	Xarelto	rivaroxaban	EMEA/H/C/000944 Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.AdultsPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.	Authorised	no	no	no	2008-09-30

International Patents for RIVAROXABAN

Country	Patent Number	Title	Estimated Expiration
Israel	205242	SUBSTITUTED OXAZOLIDINONES, PROCESSES FOR THEIR PREPARATION, COMPOSITIONS COMPRISING THEM AND USES THEREOF FOR THE MANUFACTURE OF MEDICAMENTS FOR THE TREATMENT OF DISEASES
Taiwan	I226330
Germany	50009607
Cuba	23208	OXAZOLIDINONAS SUSTITUIDAS Y SU USO EN EL CAMPO DE LA COAGULACION SANGUINEA
Taiwan	200640441	Prevention and treatment of thromboembolic disorders
El Salvador	2002000245	OXAZOLIDINONAS SUBSTITUIDAS Y SU USO REF. LEA 34122-SV
Cuba	23551	PROCEDIMIENTO PARA LA PRODUCCIÓN DE UNA COMPOSICIÓN FARMACÉUTICA SÓLIDA DE ADMINISTRACIÓN ORAL

Supplementary Protection Certificates for RIVAROXABAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261606	SPC/GB09/008	United Kingdom		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	CA 2008 00050	Denmark		PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS
1261606	361	Finland
1261606	C 2008 019	Romania		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	PA2008018,C1261606	Lithuania		PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
1261606	PA 2008 018, C 1261606	Lithuania		PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
1261606	C01261606/01	Switzerland		FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE