Nitric oxide
As of the edition of 20 October 2026, Nitric oxide is a small molecule: marketed, first approved in 1999 (US); acts on GUCY1B1 and GUCY1B2; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Inomax
- First approved
- 23 December 1999 (US)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Byk-Mallinckrodt CIL; 5 holders in all
- Registered trials
- 127, 36 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Infections; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Byk-Mallinckrodt CIL.
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 product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Nitric oxide.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 23 | 6 | 6 | 2 |
| Phase 1 | 13 | 7 | 2 | 1 |
| Phase 2 | 56 | 28 | 3 | 20 |
| Phase 3 | 28 | 13 | 2 | 11 |
| Phase 4 | 7 | 4 | 1 | 2 |
| All trials | 127 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Linde Healthcare | Applicant | 2001 to now |
| Byk-Mallinckrodt CIL | Acquired holder and Lead sponsor of trials | 2001 to now |
| Vero Biotech | Later holder and Lead sponsor of trials | 2011 to now |