Orange Book product · Brand (NDA)
PEDMARK
SODIUM THIOSULFATE
At a glance
Sep 20, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 20, 2022
3 yr 10 mo ago
Today
Exclusivity ends · ODE-384
Orphan-drug exclusivity (7 years)
Sep 20, 2029
in 3 yr 4 mo
Patent 10596190 expires
Listed method-of-use patent (U-3443) expiration.
Jan 05, 2038
in 11 yr 9 mo
Patent 11291728 expires
Listed drug product patent expiration.
Jul 01, 2039
in 13 yr 3 mo
Patent 11510984 expires
Listed drug product patent expiration.
Jul 01, 2039
in 13 yr 3 mo
Patent 11617793 expires
Listed drug product patent expiration.
Jul 01, 2039
in 13 yr 3 mo
Patent 11964018 expires
Listed method-of-use patent (U-3898) expiration.
Jul 01, 2039
in 13 yr 3 mo
Patent 11992530 expires
Listed method-of-use patent (U-3948) expiration.
Jul 01, 2039
in 13 yr 3 mo
Patent 11998604 expires
Listed method-of-use patent (U-3952) expiration.
Jul 01, 2039
in 13 yr 3 mo
Pharmaceutical detail
Active ingredient
SODIUM THIOSULFATE
Strength
12.5GM/100ML (125MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212937
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- ODE-384Orphan-drug exclusivity (7 years)
Sep 20, 2029
in 3 yr 4 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10596190 | Jan 05, 2038 | in 11 yr 9 mo | U-3443Delisted |
| 11291728 | Jul 01, 2039 | in 13 yr 3 mo | Product |
| 11510984 | Jul 01, 2039 | in 13 yr 3 mo | Product |
| 11617793 | Jul 01, 2039 | in 13 yr 3 mo | Product |
| 11964018 | Jul 01, 2039 | in 13 yr 3 mo | U-3898 |
| 11992530 | Jul 01, 2039 | in 13 yr 3 mo | U-3948 |
| 11998604 | Jul 01, 2039 | in 13 yr 3 mo | U-3952 |
