FDA Orange Book · active-ingredient family
Sparsentan
Sparsentan is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:FILSPARI · NDA 216403
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FILSPARIRLD×2 | TRAVERE | NDA 216403 | — | Feb 17, 2023 |
Marketing exclusivity (6)
- NCENew chemical entity exclusivity (5 years)
Feb 17, 2028
in 1 yr 8 mo
- ODE-389Orphan-drug exclusivity (7 years)
Feb 17, 2030
in 3 yr 9 mo
- ODE-493Orphan-drug exclusivity (7 years)
Sep 05, 2031
in 5 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Feb 17, 2028
in 1 yr 8 mo
- ODE-389Orphan-drug exclusivity (7 years)
Feb 17, 2030
in 3 yr 9 mo
- ODE-493Orphan-drug exclusivity (7 years)
Sep 05, 2031
in 5 yr 3 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9993461 | Mar 29, 2030 | in 3 yr 10 mo | U-3269 |
| 9662312 | Mar 29, 2030 | in 3 yr 10 mo | U-4495 |
Sparsentan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
