Orange Book product · Brand (NDA)
GENOSYL
NITRIC OXIDE
At a glance
Dec 20, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 2019
6 yr 7 mo ago
Patent 8057742 expires
Listed method-of-use patent (U-3037) expiration.
Jan 18, 2026
5 mo ago
Today
Patent 7618594 expires
Listed drug product patent expiration.
Oct 17, 2026
in 4 mo
Patent 7947227 expires
Listed method-of-use patent (U-3037) expiration.
Oct 17, 2026
in 4 mo
Patent 7560076 expires
Listed drug product patent expiration.
Apr 21, 2027
in 10 mo
Patent 9701538 expires
Listed drug product patent expiration.
Jan 28, 2029
in 2 yr 8 mo
Patent 10926054 expires
Listed drug product patent expiration.
Aug 13, 2029
in 3 yr 2 mo
Patent 8944049 expires
Listed drug product patent expiration.
Aug 13, 2029
in 3 yr 2 mo
Patent 9604028 expires
Listed method-of-use patent (U-2793) expiration.
Aug 13, 2029
in 3 yr 2 mo
Patent 11511252 expires
Listed drug product patent expiration.
Sep 21, 2029
in 3 yr 4 mo
Patent 11103669 expires
Listed drug product patent expiration.
Jun 21, 2030
in 4 yr 1 mo
Patent 8607785 expires
Listed drug product patent expiration.
Jul 14, 2030
in 4 yr 2 mo
Patent 10737051 expires
Listed drug product patent expiration.
Oct 20, 2035
in 9 yr 6 mo
Patent 10213572 expires
Listed drug product patent expiration.
Feb 12, 2036
in 9 yr 10 mo
Patent 11672938 expires
Listed method-of-use patent (U-3037) expiration.
Jul 22, 2040
in 14 yr 4 mo
Pharmaceutical detail
Active ingredient
NITRIC OXIDE
Strength
800PPM
Dosage form
GAS
Route
INHALATION
TE code
Not listed
Application
NDA 202860
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8057742 | Jan 18, 2026 | 5 mo ago | U-3037 |
| 7618594 | Oct 17, 2026 | in 4 mo | Product |
| 7947227 | Oct 17, 2026 | in 4 mo | U-3037 |
| 7560076 | Apr 21, 2027 | in 10 mo | Product |
| 9701538 | Jan 28, 2029 | in 2 yr 8 mo | Product |
| 10926054 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 8944049 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 9604028 | Aug 13, 2029 | in 3 yr 2 mo | U-2793 |
| 11511252 | Sep 21, 2029 | in 3 yr 4 mo | Product |
| 11103669 | Jun 21, 2030 | in 4 yr 1 mo | Product |
| 8607785 | Jul 14, 2030 | in 4 yr 2 mo | Product |
| 10737051 | Oct 20, 2035 | in 9 yr 6 mo | Product |
| 10213572 | Feb 12, 2036 | in 9 yr 10 mo | Product |
| 11672938 | Jul 22, 2040 | in 14 yr 4 mo | U-3037 |
