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Serving leading biopharmaceutical companies globally:

Moodys
Accenture
AstraZeneca
Boehringer Ingelheim
Covington
Cerilliant
Cipla
Fuji
Colorcon
Argus Health

Generated: January 19, 2018

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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 Pfizer Inc and Pf Prism Cv, and is included in two NDAs. There are six 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 eighty-five patent family members in fifty-seven countries.

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

US Patents and Regulatory Information for tofacitinib citrate

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc XELJANZ XR tofacitinib citrate TABLET, EXTENDED RELEASE;ORAL 208246-001 Feb 23, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Pf Prism Cv XELJANZ tofacitinib citrate TABLET;ORAL 203214-001 Nov 6, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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Non-Orange Book US Patents for 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
6,627,754 Pyrrolo[2,3-d]pyrimidine compounds ➤ Subscribe
7,432,370 Chiral salt resolution ➤ Subscribe
7,601,727 Pyrrolo[2,3-d]pyrimidine compounds ➤ Subscribe
7,803,805 Cristalline 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
7,842,699 Pyrrolo[2,3-D]pyrimidine compounds ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for tofacitinib citrate

Supplementary Protection Certificates for tofacitinib citrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017025 Lithuania ➤ Subscribe PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
0887 Netherlands ➤ Subscribe PRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2017000062 Germany ➤ Subscribe PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES CITRAT-SALZES; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1235830/01 Switzerland ➤ Subscribe PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
2017 00035 Denmark ➤ Subscribe PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Johnson and Johnson
McKesson
US Army
Novartis
Accenture
Mallinckrodt
Fuji

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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