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Generated: July 28, 2017
What are the generic drug sources for metronidazole and what is the scope of metronidazole freedom to operate?
Metronidazole is the generic ingredient in nineteen branded drugs marketed by B Braun, Galderma Labs Lp, Tolmar, Intl Medication, Able, Teva Pharms, West-ward Pharms Int, Fougera Pharms, Medicis, Superpharm, Flamingo Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Taro, Sandoz, Halsey, Par Pharm, Alembic Pharms Ltd, Allergan Sales Llc, Gd Searle Llc, Labs Af, Teva Pharms Usa, LNK, Savage Labs, Chartwell Molecules, Mylan Labs Ltd, Pliva, Watson Labs, Vivimed Labs, Valeant Pharms North, Watson Labs Inc, Appco Pharma Llc, G And W Labs, Taro Pharm, Pfizer, Baxter Hlthcare, Unichem Labs Ltd, Zydus Pharms Usa Inc, Strides Pharma, Abraxis Pharm, Ortho Mcneil Pharm, Allied Pharma Inc, Aurobindo Pharma Ltd, G And W Labs Inc, Orit Labs Llc, Claris, Abbott, and Hospira, and is included in seventy-four NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 19 |
| Patents: | 8 |
| Applicants: | 48 |
| NDAs: | 74 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packagers: see list | 81 |
| Bulk Api Vendors: see list | 110 |
| Clinical Trials: see list | 289 |
| Patent Applications: see list | 9,322 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | metronidazole at DailyMed |
| Ingredient-type | Nitroimidazoles |
| Drug Class | Nitroimidazole Antimicrobial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ivax Sub Teva Pharms | METRONIDAZOLE | metronidazole | TABLET;ORAL | 018517-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abbott | METRONIDAZOLE | metronidazole | INJECTABLE;INJECTION | 018889-001 | Nov 18, 1983 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Claris | METRONIDAZOLE IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 078084-001 | Mar 31, 2008 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Pfizer | FLAGYL I.V. RTU IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 018353-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Ivax Sub Teva Pharms | METRONIDAZOLE | metronidazole | TABLET;ORAL | 018517-002 | May 5, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Medicis | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Medicis | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2238980 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1467744 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2004122696 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1071514 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2012275292 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0021 | Belgium | ► Subscribe | 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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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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