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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Accenture
Daiichi Sankyo
McKesson
Argus Health
Chinese Patent Office
Moodys
Queensland Health
US Army
Covington

Generated: June 22, 2017

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Tofacitinib citrate - Generic Drug Details

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What are the generic sources for tofacitinib citrate and what is the scope of tofacitinib citrate freedom to operate?

Tofacitinib citrate
is the generic ingredient in two branded drugs marketed by Pf Prism Cv and Pfizer Inc, and is included in two NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tofacitinib citrate has one hundred and seventy-five patent family members in fifty-six countries.

There are nine drug master file entries for tofacitinib citrate. Two suppliers are listed for this compound.

Summary for Generic Name: tofacitinib citrate

Tradenames:2
Patents:7
Applicants:2
NDAs:2
Drug Master File Entries: see list9
Suppliers / Packagers: see list2
Bulk Api Vendors: see list34
Clinical Trials: see list548
Patent Applications: see list16
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tofacitinib citrate at DailyMed

Pharmacology for Ingredient: tofacitinib citrate

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, 2016RXYesYes6,965,027► SubscribeY ► 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
Pf Prism Cv
XELJANZ
tofacitinib citrate
TABLET;ORAL203214-001Nov 6, 2012RXYesYes7,301,023► SubscribeY ► Subscribe
Pfizer Inc
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL208246-001Feb 23, 2016RXYesYes6,956,041► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: tofacitinib citrate

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
7,842,699Pyrrolo[2,3-D]pyrimidine compounds► Subscribe
7,432,370Chiral salt resolution► Subscribe
7,601,727Pyrrolo[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
6,627,754 Pyrrolo[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 Ingredient: tofacitinib citrate

Country Document Number Estimated Expiration
Germany60007552► Subscribe
Cyprus1113322► Subscribe
MexicoPA04005401► Subscribe
Eurasian Patent Organization200301193► Subscribe
South Korea20060133117► 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: TOFACITINIB CITRATE

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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Federal Trade Commission
Accenture
Chinese Patent Office
Cantor Fitzgerald
Cerilliant
Merck
Argus Health
Dow

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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