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.

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

Activity Date Patent Number
Patent litigations
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 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 09 Aug, 2022 US10828310


Rivaroxaban's Family Patents

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
Vadodara Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
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
North York Apotex Inc.
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Toronto Apotex Inc.
Etobicoke Apotex, Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





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
Berlin Breckenridge Pharmaceutical, Inc
Boca Raton 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
Evergreen Sunshine Honey Bees LLC
Doral Sunshine Bottling Co, Inc.
Red Bay Sunshine Mills aka World Pet Care
Andrews Sunshine Dairy, LLC
Jacksonville Sunshine Peanut Company
Halifax Sunshine Mills, Inc.
Dublin Sunshine Mills, Inc
Portland Sunshine Dairy Foods Management LLC
Rochester Sunshine Fund Raising Co.
Bridgeville Sunshine Burger & Specialty Food Company, LLC
Augusta Sunshine Honey Inc.
Alhambra Sunshine Bakery
Glenwood Springs Sunshine & Moons, LLC
Tupelo Sunshine Mills, Inc.
Artesia Sunshine Evergreen Inc.
North Las Vegas Sunshine Fresh Nevada LLC
Indianapolis SUNSHINE INTERNATIONAL LLC
Maumee Sunshine Inc Of Nw Ohio
Columbus Sunshine Apiaries
Methuen Sunshine International Foods, Inc.
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
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Honolulu Taro Delight, LLC
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





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