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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Covington
Federal Trade Commission
Accenture
Novartis
Teva
Johnson and Johnson
Dow
Citi

Generated: December 16, 2017

DrugPatentWatch Database Preview

XELJANZ Drug Profile

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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 six patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in XELJANZ 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Pfizer IncXELJANZ XRtofacitinib citrateTABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Pfizer IncXELJANZ XRtofacitinib citrateTABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Pf Prism CvXELJANZtofacitinib citrateTABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for XELJANZ

Drugname Dosage Strength RLD Submissiondate
tofacitinibTablets5 mgXeljanz11/7/2016
tofacitinibExtended-release Tablets11 mgXeljanz XR11/7/2016

Non-Orange Book Patents for Tradename: XELJANZ

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
6,627,754 Pyrrolo[2,3-d]pyrimidine compounds► Subscribe
7,803,805Cristalline 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► Subscribe
7,432,370Chiral salt resolution► Subscribe
7,842,699Pyrrolo[2,3-D]pyrimidine compounds► Subscribe
7,601,727Pyrrolo[2,3-d]pyrimidine compounds► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: XELJANZ

Country Document Number Estimated Expiration
Brazil0209246► Subscribe
Iceland6993► Subscribe
TaiwanI316061► Subscribe
Bulgaria65821► Subscribe
Hong Kong1070653► Subscribe
Brazil0016263► Subscribe
Bulgaria106855► Subscribe
Israel158588► Subscribe
Japan4078074► Subscribe
Australia777911► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: XELJANZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0887Netherlands► SubscribePRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2017 00035Denmark► SubscribePRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324
1235830/01Switzerland► SubscribePRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
2017025Lithuania► SubscribePRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Accenture
Cipla
Queensland Health
US Army
UBS
McKesson
Johnson and Johnson
Mallinckrodt
US Department of Justice

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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