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Generated: December 16, 2018

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MIDAZOLAM HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for midazolam hydrochloride and what is the scope of midazolam hydrochloride freedom to operate?

Midazolam hydrochloride is the generic ingredient in five branded drugs marketed by 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, Sagent Strides, HLR, Meridian Medcl Techn, Apotex Inc, Hi Tech Pharma, Paddock Llc, Sun Pharm Inds Ltd, and Roche, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for midazolam hydrochloride. Twenty-three suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for MIDAZOLAM HYDROCHLORIDE
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for MIDAZOLAM HYDROCHLORIDE
Synonyms for MIDAZOLAM HYDROCHLORIDE
3849AH
467M968
4H-Imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, hydrochloride
4H-Imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, monohydrochloride
4H-Imidazo[1,5a][1,4]benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl-, hydrochloride
59467-96-8
8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo(1,5-a)(1,4)benzodiazepine hydrochloride
8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo(1,5-a)(1,4)benzodiazepine monohydrochloride
8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride
8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine;hydrochloride
8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5a][1,4]benzodiazepine hydrochloride
AC1L290O
AKOS024457308
Ambap59467-96-8
AN-39559
API0003386
C18H13ClFN3.ClH
C18H13ClFN3.HCl
CAS-59467-96-8
CCG-100983
CHEBI:6932
CHEMBL1200420
CPD000469160
CS-2908
D00696
Dormicum
DSSTox_CID_27824
DSSTox_GSID_47846
DSSTox_RID_82587
DTXSID8047846
EINECS 261-776-6
HSDB 6751
HY-B0676A
Hypnovel
Hypnovel hydrochloride
KB-74241
LS-77782
MFCD00864445
Midazolam (hydrochloride)
Midazolam Hcl
Midazolam hydrochloride (USAN)
Midazolam hydrochloride [USAN]
Midazolam hydrochloride preservative free
MLS001401415
NC00233
NCGC00168254-01
NCGC00168254-02
NSC-751451
NSC751451
Ro 21-3981/001
Ro 21-3981/003
Ro-213981-003
Ro-213981003
Rocam
SAM001246585
SC-47268
SCHEMBL41265
SMR000469160
TL8003788
Tox21_112613
Tox21_112613_1
UNII-W7TTW573JJ
Versed (TN)
Versed hydrochloride
W7TTW573JJ
Tentative approvals for MIDAZOLAM HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 5MG BASE/MLINJECTABLE;INJECTION
➤ Sign Up➤ Sign UpEQ 5MG BASE/MLINJECTABLE;INJECTION
➤ Sign Up➤ Sign UpEQ 5MG BASE/MLINJECTABLE;INJECTION

US Patents and Regulatory Information for MIDAZOLAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare Corp MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075637-002 Oct 31, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bedford MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075249-001 Jun 23, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Baxter Hlthcare Corp MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075637-001 Oct 31, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 077115-001 Sep 9, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apothecon MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075641-001 Oct 19, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for MIDAZOLAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hlr VERSED midazolam hydrochloride INJECTABLE;INJECTION 018654-002 May 26, 1987 ➤ Sign Up ➤ Sign Up
Roche VERSED midazolam hydrochloride SYRUP;ORAL 020942-001 Oct 15, 1998 ➤ Sign Up ➤ Sign Up
Hlr VERSED midazolam hydrochloride INJECTABLE;INJECTION 018654-001 Dec 20, 1985 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Healthtrust
Cerilliant
Merck
UBS
Dow
Daiichi Sankyo
Baxter
Fuji

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