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XELJANZ Drug Profile
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When do Xeljanz patents expire, and when can generic versions of Xeljanz launch?
Xeljanz is a drug marketed by Pf Prism Cv and Pfizer Inc and is included in two NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and ninety-three patent family members in fifty-nine 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.
US ANDA Litigation and Generic Entry Outlook for Xeljanz
Xeljanz was eligible for patent challenges on November 6, 2016.
There have been twelve 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.
Indicators of Generic Entry
Summary for XELJANZ
| International Patents: | 193 |
| US Patents: | 7 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 13 |
| Patent Applications: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for XELJANZ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ |
| DailyMed Link: | XELJANZ at DailyMed |
Recent Clinical Trials for XELJANZ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hanlim Pharm. Co., Ltd. | Phase 1 |
| Charite University, Berlin, Germany | Phase 4 |
| Stanford University | Phase 1 |
Recent Litigation for XELJANZ
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Ajanta Pharma Ltd. | 2019-03-15 |
| Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-12-07 |
| Pfizer Inc. v. Sun Pharmaceutical Industries Limited | 2018-10-03 |
Pharmacology for XELJANZ
| Drug Class | Janus Kinase Inhibitor |
| Mechanism of Action | Janus Kinase Inhibitors |
Paragraph IV (Patent) Challenges for XELJANZ
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XELJANZ | TABLET;ORAL | tofacitinib citrate | 203214 | 2016-11-07 |
US Patents and Regulatory Information for XELJANZ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for XELJANZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1235830 | Start Trial |
| Ukraine | 72290 | Start Trial |
| Poland | 221493 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XELJANZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1666481 | PA2017025,C1666481 | Lithuania | Start Trial | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
| 1666481 | CA 2017 00035 | Denmark | Start Trial | PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324 |
| 1666481 | C201730033 | Spain | Start Trial | 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 |
