FDA Orange Book · active-ingredient family
Enasidenib mesylate
Enasidenib mesylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:IDHIFA · NDA 209606
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IDHIFARLD×2 | BRISTOL MYERS SQUIBB | NDA 209606 | — | Aug 01, 2017 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10610125 | Jun 21, 2030 | in 4 yr 1 mo | U-2087 |
| 9512107 | Jan 07, 2033 | in 6 yr 8 mo | SubstanceProductU-2087 |
| 10294215 | Jan 07, 2033 | in 6 yr 8 mo | ProductU-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 |
Enasidenib mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
