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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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McKinsey
Cipla
Daiichi Sankyo
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US Department of Justice
Farmers Insurance
AstraZeneca
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Generated: October 18, 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 eighty-three 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.

Summary for Tradename: JAKAFI

US 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► 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;ORAL202192-002Nov 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► SubscribeYY ► Subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-005Nov 16, 2011RXYesYes► Subscribe► Subscribe► 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
9,206,187Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase► Subscribe
8,530,485Heteroaryl 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
8,946,245Heteroaryl 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
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
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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
SloveniaEP2426129► Subscribe
Spain2612196► Subscribe
South Korea20150036210► Subscribe
SloveniaEP2474545► Subscribe
European Patent Office2343299► Subscribe
Hong Kong1124840► Subscribe
Spain2575797► Subscribe
Japan5475653► Subscribe
South Africa200908826► Subscribe
China101448826► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: JAKAFI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
5 1-2013Slovakia► SubscribeFORMER OWNER: INCYTE CORPORATION, WILMINGTON, DE, US;
13/004Ireland► SubscribePRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THREOF; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2017012Lithuania► SubscribePRODUCT NAME: RUKSOLITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/773/001-006 20150311
2013000015Germany► SubscribePRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2017 00018Denmark► SubscribePRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: EU/1/12/773/001-016/C(2015)1740 20150313
2013002Lithuania► Subscribe
2017 00018Denmark► SubscribePRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: C(2015)1740/EU/1/12/773/001-016 20150313
8Finland► Subscribe
2013Austria► SubscribePRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
137Luxembourg► SubscribePRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
Johnson and Johnson
Express Scripts
Citi
AstraZeneca
Teva
Queensland Health
Cerilliant
Healthtrust

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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