FDA Orange Book · active-ingredient family
Olutasidenib
Olutasidenib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:REZLIDHIA · NDA 215814
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REZLIDHIARLD | RIGEL PHARMS | NDA 215814 | — | Dec 01, 2022 |
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Dec 01, 2027
in 1 yr 6 mo
- ODE-413Orphan-drug exclusivity (7 years)
Dec 01, 2029
in 3 yr 6 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9834539 | Sep 18, 2035 | in 9 yr 5 mo | SubstanceProductU-3497 |
| 12275715 | Sep 18, 2035 | in 9 yr 5 mo | SubstanceProductU-3684 |
| 10414752 | Sep 18, 2035 | in 9 yr 5 mo | Product |
| 10550098 | Sep 18, 2035 | in 9 yr 5 mo | Product |
| 11498913 | Sep 18, 2035 | in 9 yr 5 mo | Product |
| 11497743 | May 16, 2039 | in 13 yr 1 mo | U-3495 |
| 11376246 | May 16, 2039 | in 13 yr 1 mo | U-3495 |
| 11013734 | May 16, 2039 | in 13 yr 1 mo | U-3495 |
| 11013733 | May 16, 2039 | in 13 yr 1 mo | U-3496 |
| 10532047 | May 16, 2039 | in 13 yr 1 mo | Substance |
| 12053463 | May 16, 2039 | in 13 yr 1 mo | SubstanceProduct |
| 10959994 | May 16, 2039 | in 13 yr 1 mo | Product |
| 11738018 | Jul 17, 2039 | in 13 yr 3 mo | U-3684 |
| 11723905 | Nov 12, 2039 | in 13 yr 7 mo | Product |
Olutasidenib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
