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Last Updated: January 19, 2020

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METRONIDAZOLE HYDROCHLORIDE - Generic Drug Details

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

Metronidazole hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer and Abraxis Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for metronidazole hydrochloride.

Summary for METRONIDAZOLE HYDROCHLORIDE
Recent Clinical Trials for METRONIDAZOLE HYDROCHLORIDE

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

SponsorPhase
University of AmsterdamPhase 2
London School of Hygiene and Tropical MedicinePhase 3
Todd LeePhase 4

See all METRONIDAZOLE HYDROCHLORIDE clinical trials

Synonyms for METRONIDAZOLE HYDROCHLORIDE
1H-Imidazole-1-ethanol, 2-methyl-5-nitro-, hydrochloride
1H-Imidazole-1-ethanol, 2-methyl-5-nitro-, monohydrochloride
1H-Imidazole-1-ethanol,2-methyl-5-nitro-, hydrochloride (1:1)
2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethanol hydrochloride
2-(2-methyl-5-nitro-1h-imidazol-1-yl)ethanol hydrochloride(1:1)
2-(2-methyl-5-nitroimidazol-1-yl)ethanol hydrochloride
2-Methyl-5-nitroimidazole-1-ethanol hydrochloride
2-Methyl-5-nitroimidazole-1-ethanol monohydrochloride
69198-10-3
76JC1633UF
AC1L2A27
AC1Q38LL
AKOS028109662
C6H9N3O3.HCl
CHEBI:50687
CHEMBL1200869
CTK5C9220
D05016
DTXSID70219228
FLAGYL I.V
Flagyl I.V.
Flagyl I.V. (TN)
Imidazole-1-ethanol, 2-methyl-5-nitro-, hydrochloride
LS-78668
Metrogel - Vaginal
Metronidazole Hcl
Metronidazole hydrochloride (USAN)
Metronidazole hydrochloride [USAN]
SC 32642
SC-32642
SCHEMBL40922
UNII-76JC1633UF

US Patents and Regulatory Information for METRONIDAZOLE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Pharm METRONIDAZOLE HYDROCHLORIDE metronidazole hydrochloride INJECTABLE;INJECTION 070295-001 Oct 15, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer FLAGYL I.V. metronidazole hydrochloride INJECTABLE;INJECTION 018353-001 Approved Prior to Jan 1, 1982 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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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Harvard Business School
Merck
Express Scripts
McKinsey

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