FDA Orange Book · active-ingredient family
Ivosidenib
Ivosidenib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TIBSOVO · NDA 211192
1
Brand (NDA)
0
Generics (ANDA)
10
Listed patents
4
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TIBSOVORLD | SERVIER | NDA 211192 | — | Jul 20, 2018 |
Marketing exclusivity (4)
- I-924New indication exclusivity (3 years)
Oct 24, 2026
in 4 mo
- ODE-242Orphan-drug exclusivity (7 years)
May 02, 2026
2 mo ago
- ODE-368Orphan-drug exclusivity (7 years)
Aug 25, 2028
in 2 yr 3 mo
- ODE-447Orphan-drug exclusivity (7 years)
Oct 24, 2030
in 4 yr 5 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10610125 | Jun 21, 2030 | in 4 yr 1 mo | U-2784 |
| 9850277 | Jan 18, 2033 | in 6 yr 8 mo | SubstanceProductU-2534 |
| 10717764 | Jan 18, 2033 | in 6 yr 8 mo | U-3215 |
| 11667673 | Jan 18, 2033 | in 6 yr 8 mo | U-3742 |
| 9474779 | Aug 19, 2033 | in 7 yr 3 mo | SubstanceProductU-2534 |
| 9968595 | Mar 13, 2035 | in 8 yr 10 mo | ProductU-2534 |
| 10799490 | Mar 13, 2035 | in 8 yr 10 mo | ProductU-3384 |
| 10449184 | Mar 13, 2035 | in 8 yr 10 mo | Product |
| 10653710 | Oct 18, 2036 | in 10 yr 6 mo | U-3387 |
| 10980788 | Jun 07, 2039 | in 13 yr 2 mo | U-3214 |
Ivosidenib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
