Xeljanz is a drug owned by Pf Prism Cv. It is protected by 7 US drug patents filed from 2013 to 2018. Out of these, 1 drug patents are active and 6 have expired. Xeljanz'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 Dec 08, 2025. Details of Xeljanz'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
(1 year, 15 days 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, 7 months ago) |
Expired
|
| US7301023 | Chiral salt resolution |
Dec, 2020
(3 years ago) |
Expired
|
| US7265221 | Pyrrolo[2,3-d]pyrimidine compounds |
Dec, 2020
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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, 7 months ago) |
Expired
|
| US7301023 | Chiral salt resolution |
May, 2022
(2 years ago) |
Expired
|
| US7842699 | Pyrrolo[2,3-D]pyrimidine compounds |
Dec, 2020
(3 years ago) |
Expired
|
| US7091208 | Pyrrolo[2,3-D]pyrimidine compounds |
Dec, 2020
(3 years ago) |
Expired
|
| US7265221 | Pyrrolo[2,3-d]pyrimidine compounds |
Dec, 2020
(3 years ago) |
Expired
|
| US6956041 | Pyrrolo[2,3-d]pyrimidine compounds |
Dec, 2020
(3 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's patents.
Latest Legal Activities on Xeljanz's Patents
Given below is the list of recent legal activities going on the following patents of Xeljanz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 02 Jan, 2023 | US7842699 |
| Maintenance Fee Reminder Mailed Critical | 18 Jul, 2022 | US7842699 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 13 Mar, 2020 | US7301023 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 12 Nov, 2019 | US7301023 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Apr, 2019 | US7301023 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2019 | US7265221 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Apr, 2018 | US7842699 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jan, 2018 | US7091208 |
| Recordation of Patent Grant Mailed Critical | 30 Nov, 2010 | US7842699 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Nov, 2010 | US7842699 |
FDA has granted several exclusivities to Xeljanz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xeljanz, 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.
Exclusivity Information
Xeljanz holds 7 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Xeljanz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-135) | Feb 21, 2017 |
| New Chemical Entity Exclusivity(NCE) | Nov 06, 2017 |
| New Indication(I-761) | Dec 14, 2020 |
| New Indication(I-780) | May 30, 2021 |
| New Product(NP) | Sep 25, 2023 |
| New Patient Population(NPP) | Sep 25, 2023 |
| New Indication(I-879) | Dec 14, 2024 |
Several oppositions have been filed on Xeljanz'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's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xeljanz patents.
Xeljanz's Oppositions Filed in EPO
Xeljanz 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 |
|---|---|---|---|
 | |||
| EP02781589A | Nov, 2011 | Wibbelmann, Jobst | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Xeljanz 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's family patents as well as insights into ongoing legal events on those patents.
Xeljanz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xeljanz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 08, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xeljanz Generic API suppliers:
Tofacitinib Citrate is the generic name for the brand Xeljanz. 5 different companies have already filed for the generic of Xeljanz, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xeljanz's generic
How can I launch a generic of Xeljanz before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xeljanz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xeljanz'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg | 07 Nov, 2016 | 3 | 13 Mar, 2023 | 08 Dec, 2025 | Eligible |
| 10 mg | 24 Jul, 2019 | 1 | 01 Jun, 2021 | 08 Dec, 2025 | Eligible |
| 1 mg/mL | 12 Nov, 2021 | 1 | 08 Dec, 2025 |
Alternative Brands for Xeljanz
Xeljanz which is used for treating moderate to severe ulcerative colitis and rheumatoid arthritis., 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 |
| |||
| Pfizer |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tofacitinib Citrate, Xeljanz's active ingredient. Check the complete list of approved generic manufacturers for Xeljanz
About Xeljanz
Xeljanz is a drug owned by Pf Prism Cv. It is used for treating moderate to severe ulcerative colitis and rheumatoid arthritis. Xeljanz uses Tofacitinib Citrate as an active ingredient. Xeljanz was launched by Pf Prism Cv in 2012.
Approval Date:
Xeljanz was approved by FDA for market use on 06 November, 2012.
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 is 06 November, 2012, its NCE-1 date is estimated to be 06 November, 2016.
Active Ingredient:
Xeljanz uses Tofacitinib Citrate as the active ingredient. Check out other Drugs and Companies using Tofacitinib Citrate ingredient
Treatment:
Xeljanz is used for treating moderate to severe ulcerative colitis and rheumatoid arthritis.
Dosage:
Xeljanz is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |
Xeljanz is a drug owned by Pfizer Inc. It is protected by 1 US drug patent filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 08, 2025. Details of Xeljanz'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
(1 year, 15 days 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 Xeljanz's patents.
Latest Legal Activities on Xeljanz's Patents
Given below is the list of recent legal activities going on the following patents of Xeljanz.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Expire Patent Critical | 02 Jan, 2023 | US7842699 |
| Maintenance Fee Reminder Mailed Critical | 18 Jul, 2022 | US7842699 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 13 Mar, 2020 | US7301023 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 12 Nov, 2019 | US7301023 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Apr, 2019 | US7301023 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2019 | US7265221 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Apr, 2018 | US7842699 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jan, 2018 | US7091208 |
| Recordation of Patent Grant Mailed Critical | 30 Nov, 2010 | US7842699 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Nov, 2010 | US7842699 |
FDA has granted several exclusivities to Xeljanz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xeljanz, 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.
Exclusivity Information
Xeljanz holds 7 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Xeljanz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-135) | Feb 21, 2017 |
| New Chemical Entity Exclusivity(NCE) | Nov 06, 2017 |
| New Indication(I-761) | Dec 14, 2020 |
| New Indication(I-780) | May 30, 2021 |
| New Product(NP) | Sep 25, 2023 |
| New Patient Population(NPP) | Sep 25, 2023 |
| New Indication(I-879) | Dec 14, 2024 |
US patents provide insights into the exclusivity only within the United States, but Xeljanz 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's family patents as well as insights into ongoing legal events on those patents.
Xeljanz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xeljanz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 08, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xeljanz Generic API suppliers:
Tofacitinib Citrate is the generic name for the brand Xeljanz. 5 different companies have already filed for the generic of Xeljanz, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xeljanz's generic
How can I launch a generic of Xeljanz before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xeljanz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xeljanz'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg | 07 Nov, 2016 | 3 | 13 Mar, 2023 | 08 Dec, 2025 | Eligible |
| 10 mg | 24 Jul, 2019 | 1 | 01 Jun, 2021 | 08 Dec, 2025 | Eligible |
| 1 mg/mL | 12 Nov, 2021 | 1 | 08 Dec, 2025 |
Alternative Brands for Xeljanz
Xeljanz which is used for treating moderate to severe ulcerative colitis and rheumatoid arthritis., 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 |
| |||
| Pfizer |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tofacitinib Citrate, Xeljanz's active ingredient. Check the complete list of approved generic manufacturers for Xeljanz
About Xeljanz
Xeljanz is a drug owned by Pfizer Inc. It is used for treating moderate to severe ulcerative colitis and rheumatoid arthritis. Xeljanz uses Tofacitinib Citrate as an active ingredient. Xeljanz was launched by Pfizer in 2020.
Approval Date:
Xeljanz was approved by FDA for market use on 25 September, 2020.
Active Ingredient:
Xeljanz uses Tofacitinib Citrate as the active ingredient. Check out other Drugs and Companies using Tofacitinib Citrate ingredient
Treatment:
Xeljanz is used for treating moderate to severe ulcerative colitis and rheumatoid arthritis.
Dosage:
Xeljanz is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1MG BASE/ML | SOLUTION | Prescription | ORAL |