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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
UBS
AstraZeneca
Mallinckrodt
Cantor Fitzgerald
Fish and Richardson
Cipla
Johnson and Johnson

Generated: June 17, 2018

DrugPatentWatch Database Preview

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 seven 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 are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ruxolitinib phosphate profile page.
Summary for 202192
Tradename:JAKAFI
Applicant:Incyte Corp
Ingredient:ruxolitinib phosphate
Patents:7
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 N 50881-005-60
JAKAFI ruxolitinib phosphate TABLET;ORAL 202192 NDA Incyte Corporation 50881-010 N 50881-010-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 16, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 16, 2018
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS, INCLUDING PRIMARY MYELOFIBROSIS, POST-POLYCYTHEMIA VERA MYELOFIBROSIS AND POST-ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS
Regulatory Exclusivity Expiration:Dec 4, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
Patent:➤ Sign UpPatent Expiration:Dec 24, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS

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Mallinckrodt
Covington
Merck
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Federal Trade Commission
Harvard Business School
Baxter
US Army
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