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 five patents protecting this drug. Additional details are available on the JAKAFI profile page.
The generic ingredient in JAKAFI is ruxolitinib phosphate. One supplier is listed for this compound. Additional details are available on the ruxolitinib phosphate profile page.
|Mechanism of Action||Protein Kinase Inhibitors |
|Active Rx/OTC/Discontinued:||RX||Dosage:||TABLET; ORAL||Strength||EQ 5MG BASE|
|Approval Date:||Nov 16, 2011||TE:||RLD:||No|
|Patent:||7,598,257||Patent Expiration:||Dec 24, 2027||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patented Use:||FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS|
|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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