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Ruxolitinib phosphate - Generic Drug Details

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Ruxolitinib phosphate is the generic ingredient in one branded drug marketed by Incyte Corp and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seven patent family members in thirty-nine countries.

There is one drug master file entry for ruxolitinib phosphate. One supplier is listed for this compound.

Summary for Generic Name: ruxolitinib phosphate

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ruxolitinib phosphate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
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;ORAL202192-002Nov 16, 2011RXNo9,079,912► subscribe ► subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-002Nov 16, 2011RXNo8,829,013► subscribe ► subscribe
Incyte Corp
JAKAFI
ruxolitinib phosphate
TABLET;ORAL202192-005Nov 16, 2011RXYes8,722,693► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: ruxolitinib phosphate

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► subscribe
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
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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 Ingredient: ruxolitinib phosphate

Country Document Number Estimated Expiration
New Zealand569015► subscribe
South Korea20080079677► subscribe
Tunisia2009000514► 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: RUXOLITINIB PHOSPHATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0130003 00072Estonia► subscribePRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012
2013 00005Denmark► 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
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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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