DrugPatentWatch Database Preview
XELJANZ Drug Profile
Which patents cover Xeljanz, 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.
The generic ingredient in XELJANZ is tofacitinib citrate. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
Summary for XELJANZ
| US Patents: | 7 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 6 |
| 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 |
Pharmacology for XELJANZ
| Drug Class | Janus Kinase Inhibitor |
| Mechanism of Action | Janus Kinase Inhibitors |
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 | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for XELJANZ
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 11 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 5 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for XELJANZ
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Algeria | 3248 | ➤ Sign Up |
| Chile | 2008000762 | ➤ Sign Up |
| New Zealand | 528905 | ➤ Sign Up |
| South Korea | 100926875 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for XELJANZ
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017 00035 | Denmark | ➤ Sign Up | PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324 |
| 2017025 | Lithuania | ➤ Sign Up | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
| 0887 | Netherlands | ➤ Sign Up | PRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
| 1235830/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
