Orange Book product · Brand (NDA)
NAYZILAM
MIDAZOLAM
At a glance
May 17, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 17, 2019
7 yr 2 mo ago
Exclusivity ends · ODE-243
Orphan-drug exclusivity (7 years)
May 17, 2026
1 mo ago
Today
Patent 8217033 expires
Listed drug product patent expiration.
Jan 18, 2028
in 1 yr 7 mo
Patent 8809322 expires
Listed drug product patent expiration.
Jan 18, 2028
in 1 yr 7 mo
Patent 9289432 expires
Listed drug product patent expiration.
Jan 18, 2028
in 1 yr 7 mo
Patent 9687495 expires
Listed drug product patent expiration.
Jan 18, 2028
in 1 yr 7 mo
Pharmaceutical detail
Active ingredient
MIDAZOLAM
Strength
5MG/SPRAY
Dosage form
SPRAY
Route
NASAL
TE code
Not listed
Application
NDA 211321
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.
- 2022MIDAZOLAM IN 0.8% SODIUM CHLORIDEBrand (NDA)
NDA 215868 · EXELA PHARMA
- 2021MIDAZOLAM IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 211844 · INFORLIFE
- 2025MIDAZOLAM IN 0.8% SODIUM CHLORIDEGeneric (ANDA)
ANDA 218454 · B BRAUN MEDICAL
- 2024MIDAZOLAM IN 0.9% SODIUM CHLORIDEGeneric (ANDA)
ANDA 218993 · GLAND
- 2023MIDAZOLAM IN 0.9% SODIUM CHLORIDEGeneric (ANDA)
ANDA 216159 · HIKMA
Marketing exclusivity (1)
- ODE-243Orphan-drug exclusivity (7 years)
May 17, 2026
1 mo ago
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8217033 | Jan 18, 2028 | in 1 yr 7 mo | ProductU-2526 |
| 8809322 | Jan 18, 2028 | in 1 yr 7 mo | Product |
| 9289432 | Jan 18, 2028 | in 1 yr 7 mo | ProductU-2526 |
| 9687495 | Jan 18, 2028 | in 1 yr 7 mo | ProductU-2526 |
