XELJANZ XR Drug Patent 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 two Paragraph IV challenges.
This drug has one hundred and twenty-four 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. Eleven suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Xeljanz Xr
A generic version of XELJANZ XR was approved as tofacitinib citrate by AJANTA PHARMA LTD on June 1st, 2021.
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Questions you can ask:
- What is the 5 year forecast for XELJANZ XR?
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- What is Average Wholesale Price for XELJANZ XR?
Summary for XELJANZ XR
| International Patents: | 124 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 31 |
| Patent Applications: | 811 |
| 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 |
Recent Clinical Trials for XELJANZ XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eli Lilly and Company | PHASE3 |
| University Hospital, Brest | PHASE3 |
| Takeda | Phase 4 |
Pharmacology for XELJANZ XR
| Drug Class | Janus Kinase Inhibitor |
| Mechanism of Action | Janus Kinase Inhibitors |
Paragraph IV (Patent) Challenges for XELJANZ XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| XELJANZ XR | Extended-release Tablets | tofacitinib citrate | 22 mg | 208246 | 1 | 2020-12-28 |
| XELJANZ XR | Extended-release Tablets | tofacitinib citrate | 11 mg | 208246 | 1 | 2016-11-07 |
US Patents and Regulatory Information for XELJANZ XR
XELJANZ XR is protected by four US patents.
| 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 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| >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 | 208246-002 | Dec 12, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XELJANZ XR
When does loss-of-exclusivity occur for XELJANZ XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 5487
Estimated Expiration: ⤷ Start Trial
Australia
Patent: 14233850
Estimated Expiration: ⤷ Start Trial
Patent: 17203334
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2015020453
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 05604
Estimated Expiration: ⤷ Start Trial
Patent: 37328
Estimated Expiration: ⤷ Start Trial
China
Patent: 5101952
Estimated Expiration: ⤷ Start Trial
Patent: 1419817
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 24007
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 68155
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 68155
Estimated Expiration: ⤷ Start Trial
Patent: 54400
Estimated Expiration: ⤷ Start Trial
Patent: 49055
Estimated Expiration: ⤷ Start Trial
Hong Kong
Patent: 17297
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 53911
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 1400
Estimated Expiration: ⤷ Start Trial
Patent: 7967
Estimated Expiration: ⤷ Start Trial
Patent: 3032
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 41823
Estimated Expiration: ⤷ Start Trial
Patent: 14188
Estimated Expiration: ⤷ Start Trial
Patent: 14181234
Estimated Expiration: ⤷ Start Trial
Patent: 16199602
Estimated Expiration: ⤷ Start Trial
Patent: 18100300
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 15013279
Estimated Expiration: ⤷ Start Trial
Patent: 21000550
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 0792
Estimated Expiration: ⤷ Start Trial
Patent: 1227
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 68155
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 68155
Estimated Expiration: ⤷ Start Trial
Russian Federation
Patent: 74345
Estimated Expiration: ⤷ Start Trial
Patent: 15139505
Estimated Expiration: ⤷ Start Trial
Patent: 18129861
Estimated Expiration: ⤷ Start Trial
Singapore
Patent: 201810985X
Estimated Expiration: ⤷ Start Trial
Patent: 201506103U
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 68155
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 1505468
Estimated Expiration: ⤷ Start Trial
Patent: 1905100
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2151842
Estimated Expiration: ⤷ Start Trial
Patent: 2213616
Estimated Expiration: ⤷ Start Trial
Patent: 150131238
Estimated Expiration: ⤷ Start Trial
Patent: 170121332
Estimated Expiration: ⤷ Start Trial
Patent: 200103892
Estimated Expiration: ⤷ Start Trial
Patent: 210014763
Estimated Expiration: ⤷ Start Trial
Patent: 220151016
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 65134
Estimated Expiration: ⤷ Start Trial
Taiwan
Patent: 1436823
Estimated Expiration: ⤷ Start Trial
Patent: 19516
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering XELJANZ XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 095487 | ⤷ Start Trial | |
| Australia | 2014233850 | ⤷ Start Trial | |
| Australia | 2017203334 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XELJANZ XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1235830 | C01235830/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013 |
| 0733067 | SPC033/2002 | Ireland | ⤷ Start Trial | SPC033/2002: 20050111, EXPIRES: 20170821 |
| 0733067 | 91006 | Luxembourg | ⤷ Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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