METROGEL Drug Patent Profile

Which patents cover Metrogel, and what generic alternatives are available?

Metrogel is a drug marketed by Galderma Labs Lp and Bausch and is included in three NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in nineteen countries.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Metrogel

A generic version of METROGEL was approved as metronidazole by TEVA PHARMS USA on November 6^th, 1984.

Summary for METROGEL

International Patents:	28
US Patents:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	159
Clinical Trials:	14
Patent Applications:	4,193
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for METROGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METROGEL
What excipients (inactive ingredients) are in METROGEL?	METROGEL excipients list
DailyMed Link:	METROGEL at DailyMed

See drug prices for METROGEL

See drug sales revenues for METROGEL

Recent Clinical Trials for METROGEL

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

Sponsor	Phase
New York Medical College	Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Alfa Wassermann S.p.A.	Phase 2

See all METROGEL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for METROGEL

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

Paragraph IV (Patent) Challenges for METROGEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METROGEL	Topical Gel	metronidazole	1%	021789	1	2008-10-21

US Patents and Regulatory Information for METROGEL

METROGEL is protected by two US patents.

Patents protecting METROGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988	AB	RX	Yes	Yes
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	AB	RX	Yes	Yes
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	AB	RX	Yes	Yes			Y
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	AB	RX	Yes	Yes			Y

Expired US Patents for METROGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005

International Patents for METROGEL

See the table below for patents covering METROGEL around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	904720
Denmark	0404376
Hungary	207795	PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITIONS FOR TREATING VAGINAL INFECTIONS CONTAINING METRONIDAZOL
Australia	5829490
Hong Kong	1071514

Supplementary Protection Certificates for METROGEL

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