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Mallinckrodt
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Chinese Patent Office
Merck
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Generated: October 15, 2018

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XELJANZ Drug Profile

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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.

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.

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

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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

Supplementary Protection Certificates for XELJANZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2017025 Lithuania ➤ Sign Up PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
0887 Netherlands ➤ Sign Up PRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1235830/01 Switzerland ➤ Sign Up PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Julphar
Johnson and Johnson
Argus Health
Harvard Business School
Chinese Patent Office
Merck
Teva
Farmers Insurance

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.