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Details for New Drug Application (NDA): 202192

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NDA 202192 describes JAKAFI, which 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. Additional details are available on the JAKAFI profile page.

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 NDA: 202192

Incyte Corp
ruxolitinib phosphate
Formulation / Manufacturing:see details

Pharmacology for NDA: 202192

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 202192

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ruxolitinib phosphate
TABLET;ORAL 202192 NDA Incyte Corporation 50881-005 50881-005-60 60 TABLET in 1 BOTTLE, PLASTIC (50881-005-60)
ruxolitinib phosphate
TABLET;ORAL 202192 NDA Incyte Corporation 50881-010 50881-010-01 28 TABLET in 1 BOTTLE, PLASTIC (50881-010-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 16, 2011TE:RLD:No
Patent:8,415,362Patent Expiration:Dec 24, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,722,693Patent Expiration:Jun 12, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:7,598,257Patent Expiration:Dec 24, 2027Product Flag?YSubstance Flag?YDelist Request?

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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.