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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 |
