Tofacitinib Citrate Patent Expiration

Tofacitinib Citrate is Used for treating moderate to severe ulcerative colitis and rheumatoid arthritis. It was first introduced by Pf Prism Cv in its drug Xeljanz on Nov 6, 2012. Another drug containing Tofacitinib Citrate is Xeljanz Xr. 7 different companies have introduced drugs containing Tofacitinib Citrate.


Tofacitinib Citrate Patents

Given below is the list of patents protecting Tofacitinib Citrate, 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
Xeljanz Xr US10639309 Tofacitinib oral sustained release dosage forms Mar 14, 2034 Pfizer
Xeljanz Xr US11253523 Tofacitinib oral sustained release dosage forms Mar 14, 2034 Pfizer
Xeljanz Xr US9937181 Tofacitinib oral sustained release dosage forms Mar 14, 2034 Pfizer
Xeljanz USRE41783 Pyrrolo[2,3-D]pyrimidine compounds Dec 08, 2025 Pfizer
Xeljanz USRE41783 Pyrrolo[2,3-D]pyrimidine compounds Dec 08, 2025 Pf Prism Cv
Xeljanz Xr USRE41783 Pyrrolo[2,3-D]pyrimidine compounds Dec 08, 2025 Pfizer
Xeljanz US6965027 Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate Mar 25, 2023

(Expired)

Pf Prism Cv
Xeljanz US6965027 Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate Mar 25, 2023

(Expired)

Pf Prism Cv
Xeljanz Xr US6956027 N-terminally chemically modified protein compositions and methods Mar 25, 2023

(Expired)

Pfizer
Xeljanz Xr US6965027 Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate Mar 25, 2023

(Expired)

Pfizer
Xeljanz US7301023 Chiral salt resolution May 23, 2022

(Expired)

Pf Prism Cv
Xeljanz US6956041 Pyrrolo[2,3-d]pyrimidine compounds Dec 08, 2020

(Expired)

Pf Prism Cv
Xeljanz US7091208 Pyrrolo[2,3-D]pyrimidine compounds Dec 08, 2020

(Expired)

Pf Prism Cv
Xeljanz US7265221 Pyrrolo[2,3-d]pyrimidine compounds Dec 08, 2020

(Expired)

Pf Prism Cv
Xeljanz US7265221 Pyrrolo[2,3-d]pyrimidine compounds Dec 08, 2020

(Expired)

Pf Prism Cv
Xeljanz US7301023 Chiral salt resolution Dec 08, 2020

(Expired)

Pf Prism Cv
Xeljanz US7842699 Pyrrolo[2,3-D]pyrimidine compounds Dec 08, 2020

(Expired)

Pf Prism Cv
Xeljanz Xr US6956041 Pyrrolo[2,3-d]pyrimidine compounds Dec 08, 2020

(Expired)

Pfizer
Xeljanz Xr US7091208 Pyrrolo[2,3-D]pyrimidine compounds Dec 08, 2020

(Expired)

Pfizer
Xeljanz Xr US7265221 Pyrrolo[2,3-d]pyrimidine compounds Dec 08, 2020

(Expired)

Pfizer
Xeljanz Xr US7301023 Chiral salt resolution Dec 08, 2020

(Expired)

Pfizer
Xeljanz Xr US7842699 Pyrrolo[2,3-D]pyrimidine compounds Dec 08, 2020

(Expired)

Pfizer



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 Tofacitinib Citrate's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 12 Oct, 2023 US10639309
Expire Patent 02 Jan, 2023 US7842699
Maintenance Fee Reminder Mailed 18 Jul, 2022 US7842699
Recordation of Patent Grant Mailed 22 Feb, 2022 US11253523
Patent Issue Date Used in PTA Calculation 22 Feb, 2022 US11253523
Email Notification 03 Feb, 2022 US11253523
Issue Notification Mailed 02 Feb, 2022 US11253523
Mailing Corrected Notice of Allowability 27 Jan, 2022 US11253523
Email Notification 27 Jan, 2022 US11253523
Dispatch to FDC 25 Jan, 2022 US11253523


Tofacitinib Citrate's Family Patents

Family Patents

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Tofacitinib Citrate Generic API Manufacturers

Several generic applications have been filed for Tofacitinib Citrate. The first generic version for Tofacitinib Citrate was by Ajanta Pharma Ltd and was approved on Jun 1, 2021. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Jun 3, 2024.

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


1. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 1 generic for Tofacitinib Citrate. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10MG BASE

tablet Discontinued ORAL N/A Jun 1, 2021


Manufacturing Plant Locations
New

Ajanta 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 Ajanta Pharma Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Ajanta Pharma Ltd.





2. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Tofacitinib Citrate. This eq 11mg base version comes by the name TOFACITINIB. 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
EQ 11MG BASE

tablet, extended release Discontinued ORAL N/A Jun 3, 2024


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





3. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Tofacitinib Citrate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

solution Discontinued ORAL N/A Sep 25, 2023


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





4. MICRO LABS

Micro Labs Ltd has filed for 1 generic for Tofacitinib Citrate. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

tablet Discontinued ORAL N/A Mar 13, 2023


Manufacturing Plant Locations
New

Micro Labs'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 Micro Labs as present at those locations.

Country City Firm Name
India
Bangalore Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bengaluru Micro Labs Limited
Verna Micro Labs Limited





5. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Tofacitinib Citrate. Out of these eq 11mg base version comes by the name TOFACITINIB, eq 22mg base version comes by the name TOFACITINIB. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 11MG BASE

tablet, extended release Discontinued ORAL N/A Aug 19, 2021
EQ 22MG BASE

tablet, extended release Discontinued ORAL N/A Aug 19, 2021
EQ 5MG BASE

tablet Discontinued ORAL N/A Mar 13, 2023