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XELJANZ Drug Profile

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Which patents cover Xeljanz, and what substitute generic drugs are available?

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 seventy-two patent family members in fifty-five 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.

Summary for Tradename: XELJANZ

Patents:6
Applicants:2
NDAs:2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list33
Clinical Trials: see list2
Patent Applications: see list11
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:XELJANZ at DailyMed

Pharmacology for Tradename: XELJANZ

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
XELJANZ
tofacitinib citrate
TABLET;ORAL203214-001Nov 6, 2012RXYesYes7,091,208► Subscribe ► Subscribe
Pf Prism Cv
XELJANZ
tofacitinib citrate
TABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► Subscribe
Pf Prism Cv
XELJANZ
tofacitinib citrate
TABLET;ORAL203214-001Nov 6, 2012RXYesYes7,265,221► SubscribeY ► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes7,265,221► SubscribeY ► Subscribe
Pf Prism Cv
XELJANZ
tofacitinib citrate
TABLET;ORAL203214-001Nov 6, 2012RXYesYes► Subscribe► Subscribe
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Paragraph IV activity for: XELJANZ

Drugname Dosage Strength RLD Submissiondate
tofacitinibTablets5 mgXeljanz 11/7/2016
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
7,601,727Pyrrolo[2,3-d]pyrimidine compounds► Subscribe
7,432,370Chiral salt resolution► Subscribe
7,842,699Pyrrolo[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
Spain2295495► Subscribe
Argentina045680► Subscribe
Poland218519► Subscribe
Japan2004534047► Subscribe
Japan2005511696► 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
1235830/01Switzerland► SubscribePRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
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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. 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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