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Serving leading biopharmaceutical companies globally:

UBS
AstraZeneca
Deloitte
McKesson
Novartis
Fuji
Express Scripts
Daiichi Sankyo
McKinsey
Farmers Insurance

Generated: November 24, 2017

DrugPatentWatch Database Preview

XELJANZ XR Drug Profile

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Which patents cover Xeljanz Xr, and what generic Xeljanz Xr 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 and four supplementary protection certificates in four 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.

Pharmacology 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;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for XELJANZ XR

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

Non-Orange Book Patents for Tradename: 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
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 XR

Country Document Number Estimated Expiration
Peru08072003► Subscribe
Ukraine80093► Subscribe
Yugoslavia41302► Subscribe
African Intellectual Property Organization (OAPI)12612► Subscribe
Hong Kong1051195► Subscribe
Peru05612003► Subscribe
Canada2469350► Subscribe
Norway20093135► Subscribe
TaiwanI264305► Subscribe
Hungary0203503► 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 XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
2017025Lithuania► SubscribePRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1235830/01Switzerland► SubscribePRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cipla
Medtronic
Baxter
Deloitte
AstraZeneca
Fish and Richardson
Teva
Cerilliant
Daiichi Sankyo
UBS

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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