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Last Updated: March 28, 2024

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 eight 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:8
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202192
Generic Entry Date for 202192*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 202192
Mechanism of ActionJanus 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 16, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 22, 2024
Regulatory Exclusivity Use:ADDITION OF THE INDICATION OF TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Regulatory Exclusivity Expiration:Jun 19, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Mar 22, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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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 verification 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.