Rivaroxaban Patent Expiration

Rivaroxaban is Used for reducing the risk of clot-related complications in various cardiovascular conditions, including deep vein thrombosis and pulmonary embolism in pediatric and adult patients. It was first introduced by Janssen Pharmaceuticals Inc in its drug Xarelto on Jul 1, 2011. 14 different companies have introduced drugs containing Rivaroxaban.

Rivaroxaban Patents

Given below is the list of patents protecting Rivaroxaban, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in	Drug Patent Number	Drug Patent Title	Drug Patent Expiry	Drug Owner
Xarelto	US10828310 (Pediatric)	Reducing the risk of cardiovascular events	Jul 31, 2039	Janssen Pharms
Xarelto	US10828310	Reducing the risk of cardiovascular events	Jan 31, 2039	Janssen Pharms
Xarelto	US9539218 (Pediatric)	Prevention and treatment of thromboembolic disorders	Aug 17, 2034	Janssen Pharms
Xarelto	US9539218	Prevention and treatment of thromboembolic disorders	Feb 17, 2034	Janssen Pharms
Xarelto	US9415053 (Pediatric)	Solid, orally administrable pharmaceutical composition	May 13, 2025 (Expired)	Janssen Pharms
Xarelto	US7157456 (Pediatric)	Substituted oxazolidinones and their use in the field of blood coagulation	Feb 28, 2025 (Expired)	Janssen Pharms
Xarelto	US9415053	Solid, orally administrable pharmaceutical composition	Nov 13, 2024 (Expired)	Janssen Pharms
Xarelto	US7157456	Substituted oxazolidinones and their use in the field of blood coagulation	Aug 28, 2024 (Expired)	Janssen Pharms
Xarelto	US7585860	Substituted oxazolidinones and their use in the field of blood coagulation	Dec 11, 2020 (Expired)	Janssen Pharms
Xarelto	US7585860	Substituted oxazolidinones and their use in the field of blood coagulation	Dec 11, 2020 (Expired)	Janssen Pharms
Xarelto	US7592339	Substituted oxazolidinones and their use in the field of blood coagulation	Dec 11, 2020 (Expired)	Janssen Pharms

A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rivaroxaban's patents.

Latest Legal Activities on Rivaroxaban's Patents

Given below is the list recent legal activities going on the following patents of Rivaroxaban.

Activity	Date	Patent Number

Payment of Maintenance Fee, 8th Year, Large Entity	26 Jun, 2024	US9539218
Payment of Maintenance Fee, 4th Year, Large Entity	24 Apr, 2024	US10828310
Payment of Maintenance Fee, 8th Year, Large Entity	31 Jan, 2024	US9415053
Termination or Final Written Decision	28 Jul, 2023	US10828310
Request for Trial Granted Critical	19 Oct, 2022	US10828310
Petition Requesting Trial	30 Sep, 2022	US10828310
Petition Requesting Trial	27 Sep, 2022	US10828310
Petition Requesting Trial	09 Sep, 2022	US10828310
Petition Requesting Trial	08 Sep, 2022	US10828310
Request for Trial Granted Critical	09 Aug, 2022	US10828310

Rivaroxaban's Family Patents

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Clinical Trials

Recent Clinical Trials on Rivaroxaban:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Rivaroxaban has 1 clinical trial that has been verified in 2024.

Title	Lead Sponsor	Collaborators	Status	Phases
Rivaroxaban or Aspirin As Thromboprophylaxis in Multiple Myeloma	Lawson Health Research Institute	The Ottawa Hospital, Dalhousie University, Niagara Health System, Hamilton Health Sciences Corporation	ACTIVE NOT RECRUITING (Feb, 2024)	PHASE2, PHASE3
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority	Population Health Research Institute	University of Cape Town	WITHDRAWN (Jul, 2022)	PHASE3
Alexa, What is Eliquis and Xarelto?	Cedars-Sinai Medical Center		TERMINATED (Mar, 2022)	NA
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.	Fadoi Foundation, Italy	University Of Perugia	COMPLETED (Feb, 2022)	PHASE3
Reveal Transition - A Mechanistic Study in Transition / Stabilized Phase of CAD	University Hospital Tuebingen	Bayer	WITHDRAWN (Jun, 2019)
Absorption of Rivaroxaban in Patients With Cervical Spinal Cord Injury	Swiss Paraplegic Research, Nottwil		WITHDRAWN (Jan, 2019)	PHASE4
Relative Bioavailability Study in Healthy Subjects Comparing 2 Dry Powder Oral Suspensions of Rivaroxaban Under Fasting and 20 mg of an Oral Suspension of Rivaroxaban Under Fed Conditions to 10 mg of an Immediate Release Tablet Under Fasting Conditions	Bayer	Janssen Research & Development, LLC	COMPLETED (Jun, 2015)	PHASE1
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Bayer	COMPLETED (Aug, 2014)	PHASE3
Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation	Tohoku University		UNKNOWN (May, 2014)
Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban	Assistance Publique - Hôpitaux de Paris		COMPLETED (Mar, 2011)	PHASE2, PHASE3

Rivaroxaban Generic API Manufacturers

Several generic applications have been filed for Rivaroxaban. The first generic version for Rivaroxaban was by Taro Pharmaceutical Industries Ltd and was approved on Mar 3, 2025. And the latest generic version is by Aurobindo Pharma Ltd and was approved on May 15, 2025.

Given below is the list of companies who have filed for Rivaroxaban generic, along with the locations of their manufacturing plants worldwide.

1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Alembic.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2.5MG	tablet	Prescription	ORAL	AB	May 14, 2025
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025

Manufacturing Plant Locations
^New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country

City

Firm Name

India

Vadodara	Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal	Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal	Alembic Pharmaceuticals Limited
Panelav	Alembic Pharmaceuticals Limited
Vadodara	Alembic Pharmaceuticals Limited
Vadodara	Alembic Pharmaceuticals Ltd
Vadodara	Alembic Pharmaceuticals, Ltd

2. APOTEX

Apotex Inc has filed for 1 generic for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Apotex.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2.5MG	tablet	Prescription	ORAL	AB	May 2, 2025

Manufacturing Plant Locations
^New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country

City

Firm Name

United States

Weston

Apotex Corp.

Canada

Winnipeg	Apotex Fermentation Inc.
Brantford	Apotex Pharmachem Inc.
Richmond Hill	Apotex Inc.
Etobicoke	Apotex, Inc.
Toronto	Apotex Inc.
North York	Apotex Inc.

India

Bengaluru	Apotex Research Private Limited
Bangalore	Apotex Pharmachem India Pvt Ltd.
Bangalore	Apotex Research Private Limited - Bioequivalence Centre

3. ASCENT PHARMS INC

Ascent Pharmaceuticals Inc has filed for 4 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Ascent Pharms Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
20MG	tablet	Prescription	ORAL	AB	May 14, 2025
2.5MG	tablet	Prescription	ORAL	AB	May 14, 2025
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025

4. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2.5MG	tablet	Prescription	ORAL	AB	Apr 10, 2025
20MG	tablet	Prescription	ORAL	AB	May 15, 2025
15MG	tablet	Prescription	ORAL	AB	May 15, 2025
10MG	tablet	Prescription	ORAL	AB	May 15, 2025

Manufacturing Plant Locations
^New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country

City

Firm Name

India

Medchal

Aurobindo Pharma Ltd

5. BIOCON PHARMA

Biocon Pharma Ltd has filed for 4 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Biocon Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025
2.5MG	tablet	Prescription	ORAL	AB	May 14, 2025

Manufacturing Plant Locations
^New

Biocon Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Biocon Pharma as present at those locations.

Country

City

Firm Name

India

Bengaluru

Biocon Pharma Limited

6. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 3 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Prescription	ORAL	AB	May 15, 2025
15MG	tablet	Prescription	ORAL	AB	May 15, 2025
20MG	tablet	Prescription	ORAL	AB	May 15, 2025

Manufacturing Plant Locations
^New

Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.

Country

City

Firm Name

United States

Boca Raton	Breckenridge Pharmaceutical, Inc.
Berlin	Breckenridge Pharmaceutical, Inc

7. CHANGZHOU PHARM

Changzhou Pharmaceutical Factory has filed for 3 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Changzhou Pharm.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025

Manufacturing Plant Locations
^New

Changzhou Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Changzhou Pharm as present at those locations.

Country

City

Firm Name

China

Changzhou

Changzhou Pharmaceutical Factory

8. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 4 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2.5MG	tablet	Prescription	ORAL	AB	May 14, 2025
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025

9. INVAGEN PHARMS

Invagen Pharmaceuticals Inc has filed for 3 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Invagen Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025

10. LUPIN LTD

Lupin Ltd has filed for 4 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2.5MG	tablet	Prescription	ORAL	AB	Mar 3, 2025
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025

Manufacturing Plant Locations
^New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country

City

Firm Name

India

Aurangabad

Lupin Ltd.

11. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2.5MG	tablet	Prescription	ORAL	AB	May 14, 2025
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025

12. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 3 different strengths of generic version for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Prescription	ORAL	AB	May 14, 2025
15MG	tablet	Prescription	ORAL	AB	May 14, 2025
20MG	tablet	Prescription	ORAL	AB	May 14, 2025

Manufacturing Plant Locations
^New

Sunshine's manufacturing plants are situated in 6 countries - United States, Peru, India, Thailand, China, Mozambique. Given below are the details of these plant locations as well as the firm names of Sunshine as present at those locations.

Country

City

Firm Name

United States

Augusta	Sunshine Honey Inc.
Glenwood Springs	Sunshine & Moons, LLC
Columbus	Sunshine Apiaries
Portland	Sunshine Dairy Foods Management LLC
Bridgeville	Sunshine Burger & Specialty Food Company, LLC
Maumee	Sunshine Inc Of Nw Ohio
Indianapolis	SUNSHINE INTERNATIONAL LLC
Jacksonville	Sunshine Peanut Company
Doral	Sunshine Bottling Co, Inc.
Artesia	Sunshine Evergreen Inc.
North Las Vegas	Sunshine Fresh Nevada LLC
Dublin	Sunshine Mills, Inc
Tupelo	Sunshine Mills, Inc.
Halifax	Sunshine Mills, Inc.
Evergreen	Sunshine Honey Bees LLC
Alhambra	Sunshine Bakery
Red Bay	Sunshine Mills aka World Pet Care
Rochester	Sunshine Fund Raising Co.
Methuen	Sunshine International Foods, Inc.
Andrews	Sunshine Dairy, LLC

Peru

Tambogrande

Sunshine Export S.A.C

India

Surat

Sunshine Global Hospital

Thailand

Tha Mai

Sunshine International

China

Dongguan

Sunshine Lake Pharma Co., Ltd

Mozambique

Boane

Sunshine Nut Limitada

13. TARO

Taro Pharmaceutical Industries Ltd has filed for 1 generic for Rivaroxaban. Given below are the details of the strengths of this generic introduced by Taro.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2.5MG	tablet	Prescription	ORAL	AB	Mar 3, 2025

Manufacturing Plant Locations
^New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country

City

Firm Name

United States

Honolulu	Taro Delight, LLC
Hawthorne	Taro Pharmaceuticals U.S.A., Inc.

Israel

Haifa

Taro Pharmaceutical Industries, Ltd.

Canada

Brampton

Taro Pharmaceuticals Inc.

Pharsight

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Rivaroxaban Patent Expiration

Rivaroxaban Patents

Latest Legal Activities on Rivaroxaban's Patents

Rivaroxaban's Family Patents

Explore Our Curated Drug Screens

Clinical Trials

Recent Clinical Trials on Rivaroxaban:

Rivaroxaban Generic API Manufacturers

1. ALEMBIC

Manufacturing Plant Locations
^New

2. APOTEX

Manufacturing Plant Locations
^New

3. ASCENT PHARMS INC

4. AUROBINDO PHARMA LTD

Manufacturing Plant Locations
^New

5. BIOCON PHARMA

Manufacturing Plant Locations
^New

6. BRECKENRIDGE

Manufacturing Plant Locations
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7. CHANGZHOU PHARM

Manufacturing Plant Locations
^New

8. DR REDDYS

9. INVAGEN PHARMS

10. LUPIN LTD

Manufacturing Plant Locations
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11. MACLEODS PHARMS LTD

12. SUNSHINE

Manufacturing Plant Locations
^New

13. TARO

Manufacturing Plant Locations
^New

Rivaroxaban News

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Rivaroxaban Patents

Latest Legal Activities on Rivaroxaban's Patents

Rivaroxaban's Family Patents

Explore Our Curated Drug Screens

Clinical Trials

Recent Clinical Trials on Rivaroxaban:

Rivaroxaban Generic API Manufacturers

1. ALEMBIC

Manufacturing Plant Locations New

2. APOTEX

Manufacturing Plant Locations New

3. ASCENT PHARMS INC

4. AUROBINDO PHARMA LTD

Manufacturing Plant Locations New

5. BIOCON PHARMA

Manufacturing Plant Locations New

6. BRECKENRIDGE

Manufacturing Plant Locations New

7. CHANGZHOU PHARM

Manufacturing Plant Locations New

8. DR REDDYS

9. INVAGEN PHARMS

10. LUPIN LTD

Manufacturing Plant Locations New

11. MACLEODS PHARMS LTD

12. SUNSHINE

Manufacturing Plant Locations New

13. TARO

Manufacturing Plant Locations New

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