DrugPatentWatch Database Preview

Metronidazole - Generic Drug Details

« Back to Dashboard

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

Metronidazole is the generic ingredient in nineteen branded drugs marketed by Pfizer, Able, Alembic Pharms Ltd, Par Pharm, Galderma Labs Lp, Cosette, Fougera Pharms, Valeant Pharms North, Taro, Tolmar, Bausch, Perrigo Uk Finco, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, B Braun, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, Mylan Labs Ltd, Labs Af, Alembic Labs, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in seventy-eight NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metronidazole has forty-four patent family members in nineteen countries.

There are eighteen drug master file entries for metronidazole. Sixty suppliers are listed for this compound.

Summary for metronidazole

International Patents:	44
US Patents:	10
Tradenames:	19
Applicants:	49
NDAs:	78
Drug Master File Entries:	18
Suppliers / Packagers:	60
Bulk Api Vendors:	148
Clinical Trials:	425
Patent Applications:	7,405
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for metronidazole
Drug Sales Revenues:	Drug sales revenues for metronidazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metronidazole
What excipients (inactive ingredients) are in metronidazole?	metronidazole excipients list
DailyMed Link:	metronidazole at DailyMed

See drug prices for metronidazole

See drug sales revenues for metronidazole

Recent Clinical Trials for metronidazole

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

Sponsor	Phase
University of Lausanne	Phase 4
University of Karachi	Phase 1/Phase 2
The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510	Phase 1/Phase 2

See all metronidazole clinical trials

Pharmacology for metronidazole

Drug Class

Nitroimidazole Antimicrobial

Medical Subject Heading (MeSH) Categories for metronidazole

Anti-Infective Agents

Antiprotozoal Agents

Radiation-Sensitizing Agents

Paragraph IV (Patent) Challenges for METRONIDAZOLE

Tradename	Dosage	Ingredient	NDA	Submissiondate
METROGEL	GEL;TOPICAL	metronidazole	021789	2008-10-21
METROGEL-VAGINAL	GEL;VAGINAL	metronidazole	020208	2004-09-02

US Patents and Regulatory Information for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	METRONIDAZOLE	metronidazole	TABLET;ORAL	018599-001	Sep 17, 1982		DISCN	No	No
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	AB	RX	Yes	Yes
Teva Pharms	VANDAZOLE	metronidazole	GEL;VAGINAL	021806-001	May 20, 2005	BX	RX	No	Yes			Y
B Braun	METRO I.V. IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	018900-001	Sep 29, 1983	AP	RX	Yes	Yes

Expired US Patents for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992

International Patents for metronidazole

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013003646
Mexico	2014000066
Russian Federation	2004122696
Japan	4611632

Supplementary Protection Certificates for metronidazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209