FDA Orange Book · active-ingredient family
Palovarotene
Palovarotene is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SOHONOS · NDA 215559
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
10
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOHONOSRLD×5 | IPSEN | NDA 215559 | — | Aug 16, 2023 |
Marketing exclusivity (10)
- NCENew chemical entity exclusivity (5 years)
Aug 16, 2028
in 2 yr 2 mo
- ODE-439Orphan-drug exclusivity (7 years)
Aug 16, 2030
in 4 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Aug 16, 2028
in 2 yr 2 mo
- ODE-439Orphan-drug exclusivity (7 years)
Aug 16, 2030
in 4 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Aug 16, 2028
in 2 yr 2 mo
- ODE-439Orphan-drug exclusivity (7 years)
Aug 16, 2030
in 4 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Aug 16, 2028
in 2 yr 2 mo
- ODE-439Orphan-drug exclusivity (7 years)
Aug 16, 2030
in 4 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Aug 16, 2028
in 2 yr 2 mo
- ODE-439Orphan-drug exclusivity (7 years)
Aug 16, 2030
in 4 yr 3 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10292954 | Aug 31, 2031 | in 5 yr 3 mo | U-3676 |
| 9789074 | Aug 31, 2031 | in 5 yr 3 mo | U-3676 |
| 9314439 | Aug 31, 2031 | in 5 yr 3 mo | U-3676 |
| 12023312 | Aug 31, 2031 | in 5 yr 3 mo | U-3966 |
| 11622959 | Jun 08, 2037 | in 11 yr 2 mo | U-3676 |
| 10864194 | Jun 08, 2037 | in 11 yr 2 mo | U-3676 |
| 12458626 | Jun 08, 2037 | in 11 yr 2 mo | U-3676 |
| 12138245 | Jun 08, 2037 | in 11 yr 2 mo | U-4031 |
| 12201614 | Jun 08, 2037 | in 11 yr 2 mo | U-4031 |
Palovarotene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
