FDA Orange Book
Is there a generic for Pedmark?
Pedmark contains sodium thiosulfate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pedmark (sodium thiosulfate). The Orange Book shows its last listed patent expires July 1, 2039 and its last listed exclusivity ends September 20, 2029.
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Pedmark products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 12.5GM/100ML (125MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 212937, held by FENNEC PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pedmark patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10596190 | January 5, 2038 | Method of use | U-3443 | 212937 |
| 11998604 | July 1, 2039 | Method of use | U-3952 | 212937 |
| 11992530 | July 1, 2039 | Method of use | U-3948 | 212937 |
| 11964018 | July 1, 2039 | Method of use | U-3898 | 212937 |
| 11617793 | July 1, 2039 | Drug product | None | 212937 |
| 11510984 | July 1, 2039 | Drug product | None | 212937 |
| 11291728 | July 1, 2039 | Drug product | None | 212937 |
Pedmark exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-384 | Orphan drug exclusivity | September 20, 2029 | 212937 |
Pedmark NDC codes
Questions
Is there a generic for Pedmark?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pedmark (sodium thiosulfate). The Orange Book shows its last listed patent expires July 1, 2039 and its last listed exclusivity ends September 20, 2029.
What is the generic name for Pedmark?
The active ingredient in Pedmark is sodium thiosulfate, per the FDA Orange Book.
When does the Pedmark patent expire?
The last patent listed for Pedmark in the Orange Book expires July 1, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.