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METROGEL Drug 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. There are two patents protecting this drug and two Paragraph IV challenges.
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-two 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 6th, 1984.
Summary for METROGEL
International Patents: | 28 |
US Patents: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 148 |
Clinical Trials: | 14 |
Patent Applications: | 4,113 |
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 |



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 |
Pharmacology for METROGEL
Drug Class | Nitroimidazole Antimicrobial |
Paragraph IV (Patent) Challenges for METROGEL
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
METROGEL | GEL;TOPICAL | metronidazole | 021789 | 2008-10-21 |
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Start Trial | |||
Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for METROGEL
Country | Patent Number | Estimated Expiration |
---|---|---|
Cyprus | 1111095 | Start Trial |
European Patent Office | 1467744 | Start Trial |
World Intellectual Property Organization (WIPO) | 9014832 | Start Trial |
China | 1649603 | Start Trial |
European Patent Office | 0355152 | Start Trial |
China | 1054507 | Start Trial |
Hungary | 207795 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for METROGEL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0328535 | 96C0021 | Belgium | Start Trial | 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 |