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.
This drug has one hundred and eighty-five patent family members in fifty-seven countries.
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
| International Patents: | 185 |
| 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 | ||||
| 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 |
|---|---|---|
| Colombia | 5271665 | ➤ Sign Up |
| Eurasian Patent Organization | 007251 | ➤ Sign Up |
| Mexico | PA03011062 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for XELJANZ
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017025 | Lithuania | ➤ Sign Up | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
| 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 |
| 2017000062 | Germany | ➤ Sign Up | PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES CITRAT-SALZES; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
