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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

Tradename:
JAKAFI
Applicant:
Incyte Corp
Ingredient:
ruxolitinib phosphate
Patents:6
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
JAKAFI
ruxolitinib phosphate
TABLET;ORAL 202192 NDA Incyte Corporation 50881-005 50881-005-60 60 TABLET in 1 BOTTLE, PLASTIC (50881-005-60)
JAKAFI
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?
Patented Use:FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS


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