FDA Orange Book · active-ingredient family
Sodium thiosulfate
Sodium thiosulfate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PEDMARK · NDA 212937
3
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
1
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PEDMARKRLD | FENNEC PHARMS INC | NDA 212937 | — | Sep 20, 2022 | |
| SODIUM THIOSULFATERLD | HOPE PHARMS | NDA 203923 | — | Feb 14, 2012 | |
| SODIUM THIOSULFATERLD | US ARMY | NDA 020166 | — | Feb 14, 1992 |
Marketing exclusivity (1)
- ODE-384Orphan-drug exclusivity (7 years)
Sep 20, 2029
in 3 yr 4 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11753301 | Feb 10, 2030 | in 3 yr 8 mo | SubstanceProductU-3682 |
| 12304813 | Feb 10, 2030 | in 3 yr 8 mo | Product |
| 9345724 | Jul 07, 2030 | in 4 yr 1 mo | SubstanceProductU-2015 |
| 10479686 | Jul 07, 2030 | in 4 yr 1 mo | ProductU-3390 |
| 9585912 | Jul 07, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 8496973 | Mar 29, 2031 | in 4 yr 10 mo | SubstanceProductU-1419 |
| 10596190 | Jan 05, 2038 | in 11 yr 9 mo | U-3443Delisted |
| 11998604 | Jul 01, 2039 | in 13 yr 3 mo | U-3952 |
| 11992530 | Jul 01, 2039 | in 13 yr 3 mo | U-3948 |
| 11964018 | Jul 01, 2039 | in 13 yr 3 mo | U-3898 |
| 11617793 | Jul 01, 2039 | in 13 yr 3 mo | Product |
| 11510984 | Jul 01, 2039 | in 13 yr 3 mo | Product |
| 11291728 | Jul 01, 2039 | in 13 yr 3 mo | Product |
Sodium thiosulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
