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Serving leading biopharmaceutical companies globally:

Accenture
Fuji
US Department of Justice
Julphar
Daiichi Sankyo
McKesson
QuintilesIMS
Queensland Health
Citi
Federal Trade Commission

Generated: December 16, 2017

DrugPatentWatch Database Preview

JAKAFI Drug Profile

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When do Jakafi patents expire, and when can generic versions of Jakafi launch?

Jakafi is a drug marketed by Incyte Corp and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-seven patent family members in forty-one countries and twenty supplementary protection certificates in thirteen countries.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ruxolitinib phosphate 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
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-003Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-003Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-005Nov 16, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-004Nov 16, 2011RXYesNo► Subscribe► SubscribeYY► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-004Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-004Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-002Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-003Nov 16, 2011RXYesNo► Subscribe► SubscribeYY► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-001Nov 16, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Incyte CorpJAKAFIruxolitinib phosphateTABLET;ORAL202192-005Nov 16, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
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Paragraph IV (Patent) Challenges for JAKAFI

Drugname Dosage Strength RLD Submissiondate
ruxolitinibTablets5 mg, 10 mg, 15 mg, 20 mg, and 25 mgJakafi12/17/2015

Non-Orange Book Patents for Tradename: JAKAFI

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
9,376,439Salts of the janus kinase inhibitor (R)-3(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylp- ropanenitrile► Subscribe
8,530,485Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors► Subscribe
9,814,722Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors► Subscribe
8,946,245Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors► Subscribe
9,206,187Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase► Subscribe
8,933,086Heteroaryl substituted pyrrolo[2,3-B]pyridines and pyrrolo[2,3-B]pyrimidines as Janus kinase inhibitors► Subscribe
8,541,425Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors► 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: JAKAFI

Country Document Number Estimated Expiration
Japan5475653► Subscribe
Cyprus1117693► Subscribe
Costa Rica20130506► Subscribe
Canada2689663► Subscribe
South Korea101324737► Subscribe
Eurasian Patent Organization200870048► Subscribe
Japan6138865► Subscribe
South Korea20120120462► Subscribe
South Korea20120120463► Subscribe
European Patent Office2173752► 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: JAKAFI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/004Ireland► SubscribePRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THREOF; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
C0007France► SubscribePRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2013002,C1966202Lithuania► SubscribePRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823
137Luxembourg► SubscribePRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
5 1-2013Slovakia► SubscribeFORMER OWNER: INCYTE CORPORATION, WILMINGTON, DE, US;
90005-5Sweden► SubscribePRODUCT NAME: RUXOLITINIB, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/12/773/001 20120823
2013002Lithuania► Subscribe
2013 00005Denmark► SubscribePRODUCT NAME: RUXOLITINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB PHOSFAT; REG. NO/DATE: EU/1/12/773/001-003 20120823
2013 00005Denmark► Subscribe
2013000015Germany► SubscribePRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
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Serving leading biopharmaceutical companies globally:

Queensland Health
Moodys
Baxter
Chinese Patent Office
US Department of Justice
Cipla
Harvard Business School
Novartis
Fish and Richardson
McKinsey

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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