Xeljanz Xr is a drug owned by Pfizer Inc. It is protected by 11 US drug patents filed from 2016 to 2022. Out of these, 4 drug patents are active and 7 have expired. Xeljanz Xr's patents have been open to challenges since 06 November, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2034. Details of Xeljanz Xr's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| USRE41783 | Pyrrolo[2,3-D]pyrimidine compounds |
Dec, 2025
(11 months from now) | Active |
| US6965027 | Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate |
Mar, 2023
(1 year, 8 months ago) |
Expired
|
| US6956027 | N-terminally chemically modified protein compositions and methods |
Mar, 2023
(1 year, 8 months ago) |
Expired
|
| US7265221 | Pyrrolo[2,3-d]pyrimidine compounds |
Dec, 2020
(4 years ago) |
Expired
|
| US7301023 | Chiral salt resolution |
Dec, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11253523 | Tofacitinib oral sustained release dosage forms |
Mar, 2034
(9 years from now) | Active |
| US10639309 | Tofacitinib oral sustained release dosage forms |
Mar, 2034
(9 years from now) | Active |
| US9937181 | Tofacitinib oral sustained release dosage forms |
Mar, 2034
(9 years from now) | Active |
| US7842699 | Pyrrolo[2,3-D]pyrimidine compounds |
Dec, 2020
(4 years ago) |
Expired
|
| US6956041 | Pyrrolo[2,3-d]pyrimidine compounds |
Dec, 2020
(4 years ago) |
Expired
|
| US7091208 | Pyrrolo[2,3-D]pyrimidine compounds |
Dec, 2020
(4 years ago) |
Expired
|
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 Xeljanz Xr's patents.
Latest Legal Activities on Xeljanz Xr's Patents
Given below is the list of recent legal activities going on the following patents of Xeljanz Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Oct, 2023 | US10639309 |
| Expire Patent Critical | 02 Jan, 2023 | US7842699 |
| Maintenance Fee Reminder Mailed Critical | 18 Jul, 2022 | US7842699 |
| Recordation of Patent Grant Mailed Critical | 22 Feb, 2022 | US11253523 |
| Patent Issue Date Used in PTA Calculation Critical | 22 Feb, 2022 | US11253523 |
| Email Notification Critical | 03 Feb, 2022 | US11253523 |
| Issue Notification Mailed Critical | 02 Feb, 2022 | US11253523 |
| Mailing Corrected Notice of Allowability | 27 Jan, 2022 | US11253523 |
| Email Notification Critical | 27 Jan, 2022 | US11253523 |
| Dispatch to FDC | 25 Jan, 2022 | US11253523 |
FDA has granted several exclusivities to Xeljanz Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xeljanz Xr, 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 Xeljanz Xr.
Exclusivity Information
Xeljanz Xr holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Xeljanz Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 06, 2017 |
| New Indication(I-761) | Dec 14, 2020 |
| New Indication(I-879) | Dec 14, 2024 |
Several oppositions have been filed on Xeljanz Xr'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 Xeljanz Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xeljanz Xr patents.
Xeljanz Xr's Oppositions Filed in EPO
Xeljanz Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 09, 2011, by Wibbelmann, Jobst. This opposition was filed on patent number EP02781589A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14726410A | Dec, 2021 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP14726410A | Dec, 2021 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP14726410A | Dec, 2021 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP14726410A | Dec, 2021 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP14726410A | Dec, 2021 | Greiner, Elisabeth | Granted and Under Opposition |
| EP14726410A | Nov, 2021 | Aera A/S | Granted and Under Opposition |
| EP02781589A | Nov, 2011 | Wibbelmann, Jobst | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Xeljanz Xr 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 Xeljanz Xr's family patents as well as insights into ongoing legal events on those patents.
Xeljanz Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xeljanz Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 14, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xeljanz Xr Generic API suppliers:
Tofacitinib Citrate is the generic name for the brand Xeljanz Xr. 5 different companies have already filed for the generic of Xeljanz Xr, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xeljanz Xr's generic
How can I launch a generic of Xeljanz Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xeljanz Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xeljanz Xr'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 Xeljanz Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 11 mg | 07 Nov, 2016 | 1 | 25 Mar, 2023 | Extinguished | |
| 22 mg | 28 Dec, 2020 | 1 | 19 Aug, 2021 | 14 Mar, 2034 | Eligible |
Alternative Brands for Xeljanz Xr
Xeljanz Xr which is used for treating ulcerative colitis, rheumatoid arthritis in adult patients., has several other brand drugs in the same treatment category and using the same active ingredient (Tofacitinib Citrate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Eli Lilly And Co |
| |||
| Pf Prism Cv |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tofacitinib Citrate, Xeljanz Xr's active ingredient. Check the complete list of approved generic manufacturers for Xeljanz Xr
About Xeljanz Xr
Xeljanz Xr is a drug owned by Pfizer Inc. It is used for treating ulcerative colitis, rheumatoid arthritis in adult patients. Xeljanz Xr uses Tofacitinib Citrate as an active ingredient. Xeljanz Xr was launched by Pfizer in 2016.
Approval Date:
Xeljanz Xr was approved by FDA for market use on 23 February, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Xeljanz Xr is 23 February, 2016, its NCE-1 date is estimated to be 06 November, 2016.
Active Ingredient:
Xeljanz Xr uses Tofacitinib Citrate as the active ingredient. Check out other Drugs and Companies using Tofacitinib Citrate ingredient
Treatment:
Xeljanz Xr is used for treating ulcerative colitis, rheumatoid arthritis in adult patients.
Dosage:
Xeljanz Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 11MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 22MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |