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Details for 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. 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

Pharmacology for NDA: 202192

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 202192

Tradename Generic Name Dosage NDA Supplier National Drug Code Package Code Package
ruxolitinib phosphate
TABLET;ORAL 202192 Incyte Corporation 50881-005 50881-005-60 60 TABLET in 1 BOTTLE, PLASTIC (50881-005-60)
ruxolitinib phosphate
TABLET;ORAL 202192 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:7,598,257Patent Expiration:Dec 24, 2027Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Nov 16, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 16, 2018
Regulatory Exclusivity Use:ORPHAN DRUG 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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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