FDA Orange Book
Is there a generic for Nithiodote?
Nithiodote contains sodium nitrite and 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 Nithiodote (sodium nitrite and sodium thiosulfate). The Orange Book shows its last listed patent expires December 24, 2031.
Run it in Rivvi
Map Nithiodote and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Nithiodote products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, solution, intravenous, intravenous | 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 201444, held by HOPE PHARMACEUTICALS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nithiodote patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11753301 | February 10, 2030 | Drug substance, Drug product | U-3681 | 201444 |
| 9687506 | February 10, 2030 | Drug product | U-3394 | 201444 |
| 9687506 | February 10, 2030 | Drug product | U-3395 | 201444 |
| 12304813 | February 10, 2030 | Drug product | None | 201444 |
| 9345724 | July 7, 2030 | Drug substance, Drug product | U-2015 | 201444 |
| 10479686 | July 7, 2030 | Drug product | U-3390 | 201444 |
| 9585912 | July 7, 2030 | Drug substance, Drug product | None | 201444 |
| 8496973 | March 29, 2031 | Drug substance, Drug product | U-1419 | 201444 |
| 8568793 | December 24, 2031 | Drug substance, Drug product | None | 201444 |
Questions
Is there a generic for Nithiodote?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nithiodote (sodium nitrite and sodium thiosulfate). The Orange Book shows its last listed patent expires December 24, 2031.
What is the generic name for Nithiodote?
The active ingredient in Nithiodote is sodium nitrite and sodium thiosulfate, per the FDA Orange Book.
When does the Nithiodote patent expire?
The last patent listed for Nithiodote in the Orange Book expires December 24, 2031. 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.