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Last Updated: February 25, 2020

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Midazolam - Generic Drug Details

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What are the generic sources for midazolam and what is the scope of patent protection?

Midazolam is the generic ingredient in six branded drugs marketed by Ucb Inc, Akorn Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, West-ward Pharms Int, Wockhardt, Mylan Asi, HLR, Meridian Medcl Techn, Hi Tech Pharma, Hikma, Paddock Llc, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in thirty-eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for midazolam. One supplier is listed for this compound. There is one tentative approval for this compound.

Drug Prices for midazolam

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Recent Clinical Trials for midazolam

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical College of WisconsinN/A
Douglas FraserPhase 3
Beni-Suef UniversityEarly Phase 1

See all midazolam clinical trials

Generic filers with tentative approvals for MIDAZOLAM
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 5MG BASE/MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for midazolam
Drug ClassBenzodiazepine
Synonyms for midazolam
08J
12-chloro-9-(2-fluorophenyl)-3-methyl-2,4,8-triazatricyclo[8.4.0.0^{2,6}]tetradeca-1(10),3,5,8,11,13-hexaene
12-chloro-9-(2-fluorophenyl)-3-methyl-2,4,8-triazatricyclo[8.4.0.0^{2,6}]tetradeca-1(14),3,5,8,10,12-hexaene
12-chloro-9-(2-fluorophenyl)-3-methyl-2,4,8-triazatricyclo[8.4.0.0;{2,6}]tetradeca-1(10),3,5,8,11,13-hexaene
467M640
4H-Imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-
4H-Imidazo[1,5-a][1,4]benzodiazepine, 8-chloro-6-(2-fluoro-phenyl)-1-methyl-, (Z)-2-butenedioate
4H-Imidazo[1,5-a][1,4]benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-
59467-70-8
8-Chlor-6-(2-fluorphenyl)-1-methyl-4H-imidazo(1,5-a)(1,4)benzodiazepin
8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine
8-Chloro-6-(o-fluorophenyl)-1-methyl-4H-imidazo(1,5-a)(1,4)benzodiazepine
8-Chloro-6-(O-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]-benzodiazepine
AC1L1HMA
ACN-036275
AKOS015842580
AN-39557
API0003385
BCP21296
BDBM21363
BIDD:GT0647
BRN 0625572
Buccolam
Buccolam (TN)
C07524
C18H13ClFN3
CHEBI:6931
CHEMBL655
CS-2907
D00550
DB00683
DDLIGBOFAVUZHB-UHFFFAOYSA-N
DEA No. 2884
Dormicum
Dormicum (TN)
Dormonid (Salt/Mix)
DTXSID5023320
EINECS 261-774-5
Flormidal (Salt/Mix)
FT-0672402
GTPL3342
HSDB 6751
HY-B0676
Hypnovel (Salt/Mix)
LS-77780
mezolam
Midazolam (JAN/USP/INN)
Midazolam [INN:BAN:JAN]
Midazolam [USP:INN:BAN:JAN]
Midazolam 0.1 mg/ml in Methanol
Midazolam 1.0 mg/ml in Methanol
Midazolam Base
Midazolam hydrochloride, solid
Midazolam hydrochloride, United States Pharmacopeia (USP) Reference Standard
Midazolam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Midazolamum
Midazolamum [INN-Latin]
NCGC00168254-01
R60L0SM5BC
Ro 21-3981
SCHEMBL35061
TL8003787
UNII-R60L0SM5BC
USL261
Versed
Versed (Salt/Mix)
ZINC95626706

US Patents and Regulatory Information for midazolam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075620-002 Nov 1, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn Inc MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075481-001 Jun 30, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075856-001 Jun 13, 2002 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075154-001 Jun 20, 2000 AP RX No No   Start Trial   Start Trial   Start Trial
Intl Medicated MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 076144-002 Jan 26, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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