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Serving 500+ biopharmaceutical companies globally:

Argus Health
Fuji
Express Scripts
Novartis
Cerilliant
McKesson
Cantor Fitzgerald
Federal Trade Commission
Queensland Health
AstraZeneca

Generated: September 25, 2017

DrugPatentWatch Database Preview

JAKAFI Drug Profile

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What is the patent landscape for Jakafi, 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 fifty patent family members in forty-one 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.

Summary for Tradename: JAKAFI

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list24
Clinical Trials: see list28
Patent Applications: see list67
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:JAKAFI at DailyMed

Pharmacology for Tradename: JAKAFI

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-003Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-003Nov 16, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-005Nov 16, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-004Nov 16, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-004Nov 16, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-004Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-002Nov 16, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-003Nov 16, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-001Nov 16, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;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
8,530,485Heteroaryl 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
8,933,086Heteroaryl 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
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
8,541,425Heteroaryl 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
Singapore10201506912R► Subscribe
Hong Kong1160137► Subscribe
CroatiaP20160717► Subscribe
Poland1966202► Subscribe
Singapore182198► Subscribe
HungaryE030235► Subscribe
Cuba23933► Subscribe
Denmark2348023► Subscribe
Cuba20120155► Subscribe
Mexico342814► 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
C0007France► SubscribePRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
0130003 00072Estonia► SubscribePRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012
2013Austria► SubscribePRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; 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
8Finland► Subscribe
2017012Lithuania► SubscribePRODUCT NAME: RUKSOLITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/773/001-006 20150311
1966202/01Switzerland► SubscribeFORMER OWNER: INCYTE CORPORATION, US
2013000015Germany► SubscribePRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2017000020Germany► SubscribePRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311
2013002Lithuania► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fuji
Accenture
Cantor Fitzgerald
Dow
Mallinckrodt
Daiichi Sankyo
Argus Health
US Department of Justice
Novartis
Farmers Insurance

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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