FDA Orange Book · active-ingredient family
Nitric oxide
Nitric oxide is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GENOSYL · NDA 202860
2
Brand (NDA)
2
Generics (ANDA)
46
Listed patents
0
Exclusivity periods
Brand (NDA) products · gas
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GENOSYLRLD | VERO BIOTECH INC | NDA 202860 | — | Dec 20, 2019 | |
| INOMAXRLD×3 | MALLINCKRODT IRELAND | NDA 020845 | — | Dec 23, 1999 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ULSPIRA | AIRGAS THERAP | ANDA 203144 | AA | Jul 27, 2023 | |
| NOXIVENT×2 | VERO BIOTECH INC | ANDA 207141 | — | Oct 02, 2018 |
Listed patents (46)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8057742 | Jan 18, 2026 | 5 mo ago | U-3037 |
| 7947227 | Oct 17, 2026 | in 4 mo | U-3037 |
| 7618594 | Oct 17, 2026 | in 4 mo | Product |
| 7560076 | Apr 21, 2027 | in 10 mo | Product |
| 9701538 | Jan 28, 2029 | in 2 yr 8 mo | Product |
| 8431163 | Jun 30, 2029 | in 3 yr 1 mo | U-1286 |
| 8795741 | Jun 30, 2029 | in 3 yr 1 mo | U-1286 |
| 8282966 | Jun 30, 2029 | in 3 yr 1 mo | U-1286 |
| 8293284 | Jun 30, 2029 | in 3 yr 1 mo | U-1286 |
| 8846112 | Jun 30, 2029 | in 3 yr 1 mo | U-1286 |
| 11931377 | Jun 30, 2029 | in 3 yr 1 mo | SubstanceProductU-3903 |
| 9604028 | Aug 13, 2029 | in 3 yr 2 mo | U-2793 |
| 8944049 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 10926054 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 11511252 | Sep 21, 2029 | in 3 yr 4 mo | Product |
| 8282966*PED | Dec 30, 2029 | in 3 yr 7 mo | |
| 8293284*PED | Dec 30, 2029 | in 3 yr 7 mo | |
| 8431163*PED | Dec 30, 2029 | in 3 yr 7 mo | |
| 8795741*PED | Dec 30, 2029 | in 3 yr 7 mo | |
| 8846112*PED | Dec 30, 2029 | in 3 yr 7 mo | |
| 11931377*PED | Dec 30, 2029 | in 3 yr 7 mo | |
| 11103669 | Jun 21, 2030 | in 4 yr 1 mo | Product |
| 8607785 | Jul 14, 2030 | in 4 yr 2 mo | Product |
| 8776795 | Jan 06, 2031 | in 4 yr 7 mo | ProductU-1226 |
| 8776794 | Jan 06, 2031 | in 4 yr 7 mo | ProductU-1226 |
| 8291904 | Jan 06, 2031 | in 4 yr 7 mo | ProductU-1226 |
| 8573210 | Jan 06, 2031 | in 4 yr 7 mo | ProductU-1453 |
| 8573209 | Jan 06, 2031 | in 4 yr 7 mo | Product |
| 9408993 | Jan 06, 2031 | in 4 yr 7 mo | ProductU-1824 |
| 9265911 | Jan 06, 2031 | in 4 yr 7 mo | ProductU-1824 |
| 9295802 | Jan 06, 2031 | in 4 yr 7 mo | ProductU-1226 |
| 8291904*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 8776795*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 8776794*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 8573209*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 8573210*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 9295802*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 9408993*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 9265911*PED | Jul 06, 2031 | in 5 yr 1 mo | |
| 9279794 | Feb 19, 2035 | in 8 yr 10 mo | ProductU-1823 |
| 9279794*PED | Aug 19, 2035 | in 9 yr 4 mo | |
| 10737051 | Oct 20, 2035 | in 9 yr 6 mo | Product |
| 10213572 | Feb 12, 2036 | in 9 yr 10 mo | Product |
| 9770570 | May 03, 2036 | in 10 yr | U-2148 |
| 9770570*PED | Nov 03, 2036 | in 10 yr 6 mo | |
| 11672938 | Jul 22, 2040 | in 14 yr 4 mo | U-3037 |
Nitric oxide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
