Xarelto is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2013 to 2021. Out of these, 8 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 31, 2039. Details of Xarelto's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7585860 | Substituted oxazolidinones and their use in the field of blood coagulation |
Dec, 2020
(3 years ago) |
Expired
|
| US7157456 | Substituted oxazolidinones and their use in the field of blood coagulation |
Aug, 2024
(a month from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7592339 | Substituted oxazolidinones and their use in the field of blood coagulation |
Dec, 2020
(3 years ago) |
Expired
|
| US7585860 | Substituted oxazolidinones and their use in the field of blood coagulation |
Dec, 2020
(3 years ago) |
Expired
|
| US9415053 | Solid, orally administrable pharmaceutical composition |
Nov, 2024
(3 months from now) | Active |
|
US7157456 (Pediatric) | Substituted oxazolidinones and their use in the field of blood coagulation |
Feb, 2025
(7 months from now) | Active |
|
US9415053 (Pediatric) | Solid, orally administrable pharmaceutical composition |
May, 2025
(9 months from now) | Active |
| US9539218 | Prevention and treatment of thromboembolic disorders |
Feb, 2034
(9 years from now) | Active |
|
US9539218 (Pediatric) | Prevention and treatment of thromboembolic disorders |
Aug, 2034
(10 years from now) | Active |
| US10828310 | Reducing the risk of cardiovascular events |
Jan, 2039
(14 years from now) | Active |
|
US10828310 (Pediatric) | Reducing the risk of cardiovascular events |
Jul, 2039
(15 years from now) | Active |
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 Xarelto's patents.
Latest Legal Activities on Xarelto's Patents
Given below is the list of recent legal activities going on the following patents of Xarelto.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Xarelto and ongoing litigations to help you estimate the early arrival of Xarelto generic.
Xarelto's Litigations
Xarelto has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 30, 2014, against patent number US9539218. The petitioner , challenged the validity or infringement of this patent, with Frank Misselwitz et al as the respondent. Click below to track the latest information on how companies are challenging Xarelto's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10828310 | September, 2022 | Final Written Decision | Bayer Pharma AG et al. | Teva Pharmaceuticals USA, Inc |
| US10828310 | September, 2022 | Final Written Decision | Bayer Pharma AG et al. | InvaGen Pharmaceuticals, Inc. et al. |
| US10828310 | February, 2022 | Final Written Decision | Bayer Pharma AG et al. | Mylan Pharmaceuticals Inc. et al. |
| US9539218 | May, 2018 | Terminated-Denied | Bayer Intellectual Property GmbH | Mylan Pharmaceuticals Inc. |
| US7157456 | October, 2016 | Terminated-Dismissed | Bayer Intellectual Property GmbH | Mylan Pharmaceuticals Inc |
| US9539218 | January, 2014 | Decision | Frank Misselwitz et al | |
FDA has granted some exclusivities to Xarelto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xarelto, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xarelto.
Exclusivity Information
Xarelto holds 11 exclusivities out of which 9 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Xarelto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-643) | Nov 04, 2014 |
| New Indication(I-662) | Nov 02, 2015 |
| New Indication(I-660) | Nov 02, 2015 |
| New Indication(I-661) | Nov 02, 2015 |
| New Chemical Entity Exclusivity(NCE) | Jul 01, 2016 |
| New Dosing Schedule(D-168) | Oct 27, 2020 |
| New Indication(I-824) | Oct 11, 2021 |
| New Indication(I-810) | Oct 11, 2022 |
| M(M-284) | Mar 10, 2023 |
| New Indication(I-867) | Aug 23, 2024 |
| Pediatric Exclusivity(PED) | Feb 23, 2025 |
Several oppositions have been filed on Xarelto's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xarelto's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xarelto patents.
Xarelto's oppositions filed in EPO
Xarelto has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 12, 2008, by Ratiopharm Gmbh. This opposition was filed on patent number EP04797879A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06706291A | Apr, 2021 | Krka, d.d., Novo mesto | Opposition rejected |
| EP06706291A | Mar, 2021 | Zentiva Group, a.s. | Opposition rejected |
| EP06706291A | Jan, 2016 | ABG Patentes, S.L. | Opposition rejected |
| EP06706291A | Jan, 2016 | Kraus & Weisert Patentanwälte PartGmbB | Opposition rejected |
| EP06706291A | Jan, 2016 | Hexal AG | Opposition rejected |
| EP06706291A | Jan, 2016 | Galenicum Health S.L. | Opposition rejected |
| EP06706291A | Jan, 2016 | Stolmár, Matthias | Opposition rejected |
| EP06706291A | Jan, 2016 | Wittkopp, Alexander | Opposition rejected |
| EP06706291A | Jan, 2016 | Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi | Opposition rejected |
| EP06706291A | Jan, 2016 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Opposition rejected |
| EP06706291A | Jan, 2016 | Teva Pharmaceutical Industries Ltd. | Opposition rejected |
| EP06706291A | Jan, 2016 | STADA Arzneimittel AG | Opposition rejected |
| EP06706291A | Jan, 2016 | Generics [UK] Limited (trading as Mylan) | Opposition rejected |
| EP06706291A | Jan, 2016 | Actavis Group PTC ehf | Opposition rejected |
| EP06706291A | Jul, 2015 | Breuer, Markus | Opposition rejected |
| EP2006000431W | Jan, 2012 | Spanolux N.V.- DIV. Balterio | Opposition rejected |
| EP04797879A | Nov, 2008 | Ratiopharm GmbH | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Xarelto is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xarelto's family patents as well as insights into ongoing legal events on those patents.
Xarelto's family patents
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Generic Launch
Generic Release Date:
Xarelto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 31, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xarelto Generics:
There are no approved generic versions for Xarelto as of now.
How can I launch a generic of Xarelto before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xarelto's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xarelto's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Xarelto -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg | 19 Nov, 2018 | 4 | 13 Nov, 2024 | ||
| 10 mg, 15 mg, and 20 mg | 01 Jul, 2015 | 8 | 28 Aug, 2024 | ||
| 10 mg, 15 mg and 20 mg | 17 Jun, 2022 | 1 | 17 Feb, 2034 |
About Xarelto
Xarelto is a drug owned by Janssen Pharmaceuticals Inc. It 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. Xarelto uses Rivaroxaban as an active ingredient. Xarelto was launched by Janssen Pharms in 2018.
Market Authorisation Date:
Xarelto was approved by FDA for market use on 11 October, 2018.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Xarelto is 11 October, 2018, its NCE-1 date is estimated to be 24 February, 2024
Active Ingredient:
Xarelto uses Rivaroxaban as the active ingredient. Check out other Drugs and Companies using Rivaroxaban ingredient
Treatment:
Xarelto 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.
Dosage:
Xarelto is available in the following dosage forms - for suspension form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET | Prescription | ORAL |
| 2.5MG | TABLET | Prescription | ORAL |
| 15MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 1MG/ML | FOR SUSPENSION | Prescription | ORAL |