INREBIC

Peak

fedratinib hydrochloride

Bristol Myers Squibb

NDAORALCAPSULEPriority Review

Approved

Aug 2019

Lifecycle

Peak

Competitive Pressure

0/100

Mechanism of Action

2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Fedratinib is a JAK2-selective inhibitor with higher inhibitory activity for JAK2 over family members JAK1, JAK3 and TYK2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms (MPNs), including myelofibrosis and polycythemia…

Indications (3)

high-risk primary secondary (post-polycythemia vera post-essential thrombocythemia) myelofibrosis (MF) ()

Loss of Exclusivity

LOE Date

Sep 24, 2039

165 months away

Patent Expiry

Sep 24, 2039

Exclusivity Expiry

Aug 16, 2026

Patent Records (5)

Patent #	Expiry	Type	Use Code
7825246	Dec 16, 2026	Substance	—
8138199	Jun 30, 2028		U-2607
7528143	Nov 16, 2031	SubstanceProduct	—
10391094	Jun 4, 2032	Product	U-2607
11400092	Sep 24, 2039		U-3409

Company

External Resources

Full prescribing information

FDA Drugs@FDA

FDA approval history

RxNorm

Drug nomenclature & identifiers