XELJANZ Drug Patent Profile
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Which patents cover Xeljanz, and when can generic versions of Xeljanz launch?
Xeljanz is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. There are five patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and nine patent family members in fifty-four countries.
The generic ingredient in XELJANZ is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
DrugPatentWatch® Generic Entry Outlook for Xeljanz
Xeljanz was eligible for patent challenges on November 6, 2016.
There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (tofacitinib citrate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for XELJANZ
International Patents: | 109 |
US Patents: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 28 |
Patent Applications: | 151 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for XELJANZ |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ |
What excipients (inactive ingredients) are in XELJANZ? | XELJANZ excipients list |
DailyMed Link: | XELJANZ at DailyMed |


Recent Clinical Trials for XELJANZ
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Phase 4 |
University of Alabama at Birmingham | Phase 4 |
Eli Lilly and Company | Phase 4 |
Pharmacology for XELJANZ
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for XELJANZ
Paragraph IV (Patent) Challenges for XELJANZ
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XELJANZ | Oral Solution | tofacitinib citrate | 1 mg/mL | 213082 | 1 | 2021-11-12 |
XELJANZ | Tablets | tofacitinib citrate | 10 mg | 203214 | 1 | 2019-07-24 |
XELJANZ | Tablets | tofacitinib citrate | 5 mg | 203214 | 3 | 2016-11-07 |
US Patents and Regulatory Information for XELJANZ
XELJANZ is protected by two US patents and three FDA Regulatory Exclusivities.
Patents protecting XELJANZ
Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pyrrolo[2,3-D]pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting XELJANZ
NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION
Exclusivity Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | XELJANZ | tofacitinib citrate | SOLUTION;ORAL | 213082-001 | Sep 25, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for XELJANZ
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | XELJANZ | tofacitinib citrate | SOLUTION;ORAL | 213082-001 | Sep 25, 2020 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | See Plans and Pricing | See Plans and Pricing |
Pfizer | XELJANZ | tofacitinib citrate | SOLUTION;ORAL | 213082-001 | Sep 25, 2020 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XELJANZ
See the table below for patents covering XELJANZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 1295001 | See Plans and Pricing | |
Denmark | 1666481 | See Plans and Pricing | |
African Intellectual Property Organization (OAPI) | 12118 | PyrroloÄ2,3-dÜpyrimidine compounds. | See Plans and Pricing |
Iceland | 6383 | See Plans and Pricing | |
New Zealand | 530380 | Optical resolution of (1-benzyl-4-methylpiperidin-3-yl) -methylamine and the use thereof for the preparation of pyrrolo 2,3-pyrimidine derivatives as protein kinases inhibitors | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XELJANZ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1666481 | 122017000062 | Germany | See Plans and Pricing | PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
1666481 | 2017/036 | Ireland | See Plans and Pricing | PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REGISTRATION NO/DATE: EU/1/17/1178/001 EU/1/17/1178/004 20170322 |
1666481 | 2017C/032 | Belgium | See Plans and Pricing | PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
1666481 | 615 | Finland | See Plans and Pricing | |
1666481 | C201730033 | Spain | See Plans and Pricing | PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |