Metronidazole hydrochloride - Generic Drug Details

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What are the generic drug 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.

Summary for metronidazole hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	526
Patent Applications:	3,188
DailyMed Link:	metronidazole hydrochloride at DailyMed

Recent Clinical Trials for metronidazole hydrochloride

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

Sponsor	Phase
Hospital Universitario Evangelico de Curitiba	Phase 3
National Dental PBRN	Phase 3
Rutgers, The State University of New Jersey	Phase 3

See all metronidazole hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for metronidazole hydrochloride

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01XD	Imidazole derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for metronidazole hydrochloride

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	FLAGYL I.V.	metronidazole hydrochloride	INJECTABLE;INJECTION	018353-001	Approved Prior to Jan 1, 1982		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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