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Metronidazole - Generic Drug Details
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This ingredient has thirty-eight patent family members in nineteen countries.
There are eighteen drug master file entries for metronidazole. Seventy-three suppliers are listed for this compound.
Summary for Generic Name: metronidazole
| Tradenames: | 19 |
| Patents: | 8 |
| Applicants: | 44 |
| NDAs: | 70 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packaging: see list | 73 |
| Therapeutic Class: | Antibacterials |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: metronidazole
| Ingredient-type | Nitroimidazoles |
| Drug Class | Nitroimidazole Antimicrobial |
Clinical Trials for: metronidazole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | METRONIDAZOLE | metronidazole | TABLET;ORAL | 018599-002 | Feb 13, 1984 | DISCN | No | ||||||||||||||||||||||
Allergan Sales Llc | NUVESSA | metronidazole | GEL;VAGINAL | 205223-001 | Mar 24, 2014 | RX | Yes | 8,658,678 | Jun 27, 2028 | ||||||||||||||||||||
Gd Searle Llc | FLAGYL | metronidazole | TABLET;ORAL | 012623-001 | Approved Prior to Jan 1, 1982 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: metronidazole
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Medicis | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | 4,837,378 | <disabled> | ||||||||||||||||||||||
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | 4,837,378 | <disabled> | ||||||||||||||||||||||
Medicis | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | 5,840,744 | <disabled> | ||||||||||||||||||||||
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International Patent Family for Ingredient: metronidazole
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2006116252 | <disabled in preview> | |||||||||||||||||||||||||||
| South Africa | 200405059 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2840571 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: METRONIDAZOLE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0021 | Belgium | <disabled> | 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 | ||||||||||||||||||||||||||
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