Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 20, 2019

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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 midazolam 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, Paddock Llc, Pd Partners, 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 are three tentative approvals for this compound.

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

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
Ucb Inc NAYZILAM midazolam SPRAY;NASAL 211321-001 May 17, 2019 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Fresenius Kabi Usa MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE midazolam hydrochloride INJECTABLE;INJECTION 203460-002 Aug 22, 2014 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hlr VERSED midazolam hydrochloride INJECTABLE;INJECTION 018654-001 Dec 20, 1985 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hi Tech Pharma MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 075958-001 Sep 4, 2003 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075396-001 Jun 20, 2000 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.