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XELJANZ XR Drug Profile
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When do Xeljanz Xr patents expire, and what generic alternatives are available?
Xeljanz Xr is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-three patent family members in fifty-five countries.
The generic ingredient in XELJANZ XR 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 Xr
Xeljanz Xr was eligible for patent challenges on November 6, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.
There have been fourteen 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 XR
| International Patents: | 143 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 20 |
| Patent Applications: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for XELJANZ XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ XR |
| DailyMed Link: | XELJANZ XR at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XELJANZ XR
Generic Entry Date for XELJANZ XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for XELJANZ XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| TWi Biotechnology, Inc. | Phase 1 |
| University of Erlangen-Nürnberg Medical School | Phase 3 |
| Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma | Phase 2 |
Pharmacology for XELJANZ XR
| Drug Class | Janus Kinase Inhibitor |
| Mechanism of Action | Janus Kinase Inhibitors |
ATC Classes for XELJANZ XR
Paragraph IV (Patent) Challenges for XELJANZ XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XELJANZ XR | TABLET, EXTENDED RELEASE;ORAL | tofacitinib citrate | 208246 | 2016-11-07 |
US Patents and Regulatory Information for XELJANZ XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| >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 XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | Get Started Free | Get Started Free |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | Get Started Free | Get Started Free |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | Get Started Free | Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XELJANZ XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | I310384 | Get Started Free |
| Ecuador | SP003819 | Get Started Free |
| Guatemala | 200200234 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XELJANZ XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1666481 | 122017000062 | Germany | Get Started Free | PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
| 1666481 | 2017C/032 | Belgium | Get Started Free | PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
| 1666481 | 17C1031 | France | Get Started Free | PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
