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Serving leading biopharmaceutical companies globally:

Deloitte
Covington
Johnson and Johnson
McKesson
Daiichi Sankyo
Farmers Insurance
US Army
Argus Health
Novartis
Citi

Generated: February 18, 2018

DrugPatentWatch Database Preview

XELJANZ XR Drug Profile

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Which patents cover Xeljanz Xr, and what generic alternatives are available?

Xeljanz Xr is a drug marketed by Pfizer Inc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-five patent family members in fifty-seven countries.

The generic ingredient in XELJANZ XR is tofacitinib citrate. There are nine 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 XR
Drug patent expirations by year for XELJANZ XR
Pharmacology for XELJANZ XR

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 Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for XELJANZ XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 11 mg ➤ Subscribe 11/7/2016

Non-Orange Book US Patents for XELJANZ XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,803,805 Cristalline 3-{(3R,4R)-4 methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}- -3-oxo-propionitrile mono citrate salt ➤ Try a Free Trial
7,432,370 Chiral salt resolution ➤ Try a Free Trial
6,627,754 Pyrrolo[2,3-d]pyrimidine compounds ➤ Try a Free Trial
7,601,727 Pyrrolo[2,3-d]pyrimidine compounds ➤ Try a Free Trial
7,842,699 Pyrrolo[2,3-D]pyrimidine compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for XELJANZ XR

Supplementary Protection Certificates for XELJANZ XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1235830/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
2017000062 Germany ➤ Try a Free Trial PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES CITRAT-SALZES; REGISTRATION NO/DATE: EU/1/17/1178 20170322
0887 Netherlands ➤ Try a Free Trial PRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2017 00035 Denmark ➤ Try a Free Trial 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 ➤ Try a Free Trial PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Accenture
Johnson and Johnson
US Department of Justice
Healthtrust
Dow
Harvard Business School
McKesson

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. thinkBiotech performs no independent verifification 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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