Orange Book product · Brand (NDA)
IDHIFA
ENASIDENIB MESYLATE
At a glance
Aug 01, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 01, 2017
9 yr ago
Today
Patent 10610125 expires
Listed method-of-use patent (U-2087) expiration.
Jun 21, 2030
in 4 yr 1 mo
Patent 10294215 expires
Listed drug product patent expiration.
Jan 07, 2033
in 6 yr 8 mo
Patent 9512107 expires
Listed drug substance patent expiration.
Jan 07, 2033
in 6 yr 8 mo
Patent 10093654 expires
Listed drug substance patent expiration.
Aug 01, 2034
in 8 yr 3 mo
Patent 9738625 expires
Listed drug substance patent expiration.
Aug 01, 2034
in 8 yr 3 mo
Patent 9732062 expires
Listed drug substance patent expiration.
Sep 16, 2034
in 8 yr 4 mo
Pharmaceutical detail
Active ingredient
ENASIDENIB MESYLATE
Strength
EQ 50MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209606
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10610125 | Jun 21, 2030 | in 4 yr 1 mo | U-2087 |
| 10294215 | Jan 07, 2033 | in 6 yr 8 mo | ProductU-2087 |
| 9512107 | Jan 07, 2033 | in 6 yr 8 mo | SubstanceProductU-2087 |
| 10093654 | Aug 01, 2034 | in 8 yr 3 mo | SubstanceProductU-2087 |
| 9738625 | Aug 01, 2034 | in 8 yr 3 mo | Substance |
| 9732062 | Sep 16, 2034 | in 8 yr 4 mo | Substance |
