FDA Orange Book · active-ingredient family
Nedosiran sodium
Nedosiran sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:RIVFLOZA · NDA 215842
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
12
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIVFLOZARLD×3 | NOVO | NDA 215842 | — | Sep 29, 2023 |
Marketing exclusivity (12)
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2028
in 2 yr 4 mo
- NPPNew patient population exclusivity (3 years)
Mar 27, 2028
in 1 yr 10 mo
- ODE-443Orphan-drug exclusivity (7 years)
Sep 29, 2030
in 4 yr 4 mo
- ODE-531Orphan-drug exclusivity (7 years)
Mar 27, 2032
in 5 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2028
in 2 yr 4 mo
- NPPNew patient population exclusivity (3 years)
Mar 27, 2028
in 1 yr 10 mo
- ODE-443Orphan-drug exclusivity (7 years)
Sep 29, 2030
in 4 yr 4 mo
- ODE-531Orphan-drug exclusivity (7 years)
Mar 27, 2032
in 5 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2028
in 2 yr 4 mo
- NPPNew patient population exclusivity (3 years)
Mar 27, 2028
in 1 yr 10 mo
- ODE-443Orphan-drug exclusivity (7 years)
Sep 29, 2030
in 4 yr 4 mo
- ODE-531Orphan-drug exclusivity (7 years)
Mar 27, 2032
in 5 yr 10 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11359203 | Oct 09, 2035 | in 9 yr 5 mo | SubstanceProductU-3709 |
| 10738311 | Oct 09, 2035 | in 9 yr 5 mo | SubstanceProductU-3709 |
| 10351854 | Oct 09, 2035 | in 9 yr 5 mo | SubstanceProduct |
| 11053502 | Oct 29, 2035 | in 9 yr 6 mo | SubstanceProduct |
| 11661604 | Oct 12, 2038 | in 12 yr 6 mo | SubstanceProductU-3709 |
| 11286488 | Oct 12, 2038 | in 12 yr 6 mo | SubstanceProductU-3709 |
Nedosiran sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
