DrugPatentWatch Database Preview
XELJANZ Drug Profile
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 eighty-nine 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.
Summary for XELJANZ
| International Patents: | 189 |
| US Patents: | 7 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 9 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for XELJANZ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ |
| Prior Art and Litigation Support | Order Prior Art and Litigation support 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 | Tablets | 5 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Extended-release Tablets | 11 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for XELJANZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2357942 | ➤ Sign Up |
| Israel | 161914 | ➤ Sign Up |
| African Regional IP Organization (ARIPO) | 1859 | ➤ Sign Up |
| European Patent Office | 1666481 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for XELJANZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1666481 | 37/2017 | Austria | ➤ Sign Up | PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES CITRATS; REGISTRATION NO/DATE: EU/1/17/1178 (MITTEILUNG) 20170324 |
| 1666481 | LUC00031 | Luxembourg | ➤ Sign Up | PRODUCT NAME: TOFACITINIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE CITRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
| 1666481 | PA2017025,C1666481 | Lithuania | ➤ Sign Up | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
| 1666481 | 2017C/032 | Belgium | ➤ Sign Up | PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
