Nitrous acid
As of the edition of 20 October 2026, Nitrous acid is a small molecule: marketed, first approved in 2011 (US); US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Nithiodote
- First approved
- 14 January 2011 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Hope Biosciences
- Registered trials
- 38, 10 stopped early
- Disease areas
- Heart and blood vessels; Blood and lymph; Inherited and neonatal; Lungs and airways; Nutrition and metabolism; Nervous system
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Hope Biosciences.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product6 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 9 | 6 | 0 | 3 |
| Phase 2 | 26 | 17 | 0 | 7 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 38 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Hope Biosciences | Originator and Lead sponsor of trials | 2010 to now |