METROGEL Drug Patent Profile

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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.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three 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.

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Summary for METROGEL

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	14
Patent Applications:	1,882
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

Drug patent expirations by year 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
Alfasigma S.p.A.	Phase 2

See all METROGEL clinical trials

Pharmacology for METROGEL

Drug Class	Nitroimidazole Antimicrobial

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

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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
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	AB	RX	Yes	Yes	⤷ 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

Expired US Patents for METROGEL

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

International Patents for METROGEL

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

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Country	Patent Number	Title	Estimated Expiration
China	1032900		⤷ Sign Up
Portugal	1467744		⤷ Sign Up
Russian Federation	2032402	COMPOSITION AND METHOD FOR TREATING VAGINITIS	⤷ Sign Up
Romania	109156	COMPOZITIE CU METRONIDAZOL,PENTRU INFECTIILE VAGINALE SI METODA DE TRATAMENT CU ACEASTA (COMPOSITION WITH METRONIDAZOLE FOR VAGINAL INFECTIONS AND TREATMENT METHOD THEREOF)	⤷ Sign Up
Brazil	0215331		⤷ Sign Up
Canada	1337279	TRAITEMENT INTRAVAGINAL D'INFECTIONS VAGINALES AU MOYEN DE COMPOSITIONS A BASE DE METRONIDAZOLE TAMPONNE (INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE COMPOSITIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for METROGEL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description