FDA Orange Book · active-ingredient family
Midazolam
Midazolam is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MIDAZOLAM IN 0.8% SODIUM CHLORIDE · NDA 215868
3
Brand (NDA)
3
Generics (ANDA)
5
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution, spray
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIDAZOLAM IN 0.8% SODIUM CHLORIDERLD×2 | EXELA PHARMA | NDA 215868 | — | Jul 20, 2022 | |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDERLD×2 | INFORLIFE | NDA 211844 | AP | Mar 22, 2021 | |
| NAYZILAMRLD | UCB INC | NDA 211321 | — | May 17, 2019 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE×2 | B BRAUN MEDICAL | ANDA 218454 | — | May 01, 2025 | |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE×2 | GLAND | ANDA 218993 | AP | Aug 12, 2024 | |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE×2 | HIKMA | ANDA 216159 | AP | Apr 17, 2023 |
Marketing exclusivity (1)
- ODE-243Orphan-drug exclusivity (7 years)
May 17, 2026
1 mo ago
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9687495 | Jan 18, 2028 | in 1 yr 7 mo | ProductU-2526 |
| 9289432 | Jan 18, 2028 | in 1 yr 7 mo | ProductU-2526 |
| 8217033 | Jan 18, 2028 | in 1 yr 7 mo | ProductU-2526 |
| 8809322 | Jan 18, 2028 | in 1 yr 7 mo | Product |
| 10966990 | Jun 20, 2038 | in 12 yr 2 mo | Product |
Midazolam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
