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JAKAFI Drug Profile

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Jakafi is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seven patent family members in thirty-nine 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:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: JAKAFI

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Clinical Trials for: JAKAFI

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-003Nov 16, 2011RXNo9,079,912<disabled> <disabled>
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-004Nov 16, 2011RXNo<disabled><disabled>
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-005Nov 16, 2011RXYes8,415,362<disabled>YY <disabled>
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Paragraph IV activity 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
8,946,245Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors<disabled in preview>
8,530,485Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors<disabled in preview>
8,933,086Heteroaryl substituted pyrrolo[2,3-B]pyridines and pyrrolo[2,3-B]pyrimidines as Janus kinase inhibitors<disabled in preview>
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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
BrazilPI0619817<disabled in preview>
TaiwanI468162<disabled in preview>
Austria525374<disabled in preview>
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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<disabled>PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THREOF; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
C0007France<disabled>PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2013Austria<disabled>PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
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