Orange Book product · Brand (NDA)
INREBIC
FEDRATINIB HYDROCHLORIDE
At a glance
Aug 16, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 16, 2019
6 yr 11 mo ago
Today
Exclusivity ends · ODE-259
Orphan-drug exclusivity (7 years)
Aug 16, 2026
in 2 mo
Patent 7825246 expires
Listed drug substance patent expiration.
Dec 16, 2026
in 6 mo
Patent 8138199 expires
Listed method-of-use patent (U-2607) expiration.
Jun 30, 2028
in 2 yr 1 mo
Patent 7528143 expires
Listed drug substance patent expiration.
Nov 16, 2031
in 5 yr 6 mo
Patent 10391094 expires
Listed drug product patent expiration.
Jun 04, 2032
in 6 yr 1 mo
Patent 11400092 expires
Listed method-of-use patent (U-3409) expiration.
Sep 24, 2039
in 13 yr 6 mo
Pharmaceutical detail
Active ingredient
FEDRATINIB HYDROCHLORIDE
Strength
EQ 100MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212327
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- ODE-259Orphan-drug exclusivity (7 years)
Aug 16, 2026
in 2 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7825246 | Dec 16, 2026 | in 6 mo | Substance |
| 8138199 | Jun 30, 2028 | in 2 yr 1 mo | U-2607 |
| 7528143 | Nov 16, 2031 | in 5 yr 6 mo | SubstanceProduct |
| 10391094 | Jun 04, 2032 | in 6 yr 1 mo | ProductU-2607 |
| 11400092 | Sep 24, 2039 | in 13 yr 6 mo | U-3409 |
