Metronidazole - Generic Drug Details
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What are the generic sources for metronidazole and what is the scope of freedom to operate?
Metronidazole
is the generic ingredient in twenty branded drugs marketed by Pfizer, Able, Alembic, Chartwell Rx, Galderma Labs Lp, Cosette, Fougera Pharms, Zydus Lifesciences, Bausch, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, B Braun, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, Rising, Saptalis Pharms, Labs Af, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in eighty-seven NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Metronidazole has twenty-one patent family members in nine countries.
There are eighteen drug master file entries for metronidazole. Sixty-nine suppliers are listed for this compound.
Summary for metronidazole
International Patents: | 21 |
US Patents: | 9 |
Tradenames: | 20 |
Applicants: | 53 |
NDAs: | 87 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 69 |
Raw Ingredient (Bulk) Api Vendors: | 172 |
Clinical Trials: | 513 |
Patent Applications: | 7,344 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for metronidazole |
Drug Sales Revenues: | Drug sales revenues for metronidazole |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for metronidazole |
What excipients (inactive ingredients) are in metronidazole? | metronidazole excipients list |
DailyMed Link: | metronidazole at DailyMed |
Recent Clinical Trials for metronidazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ministry of Health, France | Phase 3 |
Hôpital Necker-Enfants Malades | Phase 3 |
Institut Pasteur | Phase 3 |
Pharmacology for metronidazole
Drug Class | Nitroimidazole Antimicrobial |
Medical Subject Heading (MeSH) Categories for metronidazole
Paragraph IV (Patent) Challenges for METRONIDAZOLE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NUVESSA | Vaginal Gel | metronidazole | 1.30% | 205223 | 1 | 2022-03-30 |
METROGEL | Topical Gel | metronidazole | 1% | 021789 | 1 | 2008-10-21 |
METROGEL-VAGINAL | Vaginal Gel | metronidazole | 0.75% | 020208 | 1 | 2004-09-02 |
US Patents and Regulatory Information for metronidazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal | METRONIDAZOLE IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 217665-001 | May 24, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Encube | METRONIDAZOLE | metronidazole | GEL;VAGINAL | 077264-001 | Oct 31, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Taro | METRONIDAZOLE | metronidazole | GEL;TOPICAL | 077819-001 | Jul 18, 2006 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ivax Sub Teva Pharms | METRONIDAZOLE | metronidazole | TABLET;ORAL | 018517-002 | May 5, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 metronidazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | FLAGYL ER | metronidazole | TABLET, EXTENDED RELEASE;ORAL | 020868-001 | Nov 26, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for metronidazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2020007494 | FORMULACIONES ORALES DE METRONIDAZOL Y METODOS DE TRATAMIENTO DE UNA INFECCION CON LAS MISMAS. (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME.) | ⤷ Try a Trial |
Japan | 6235087 | ⤷ Try a Trial | |
European Patent Office | 2725904 | FORMULATIONS DE GEL À BASE DE MÉTRONIDAZOLE AQUEUX MUCOADHÉSIF À DOSAGE ÉLEVÉ ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTÉRIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS) | ⤷ Try a Trial |
Brazil | 112013033759 | formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for metronidazole
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0328535 | 96C0021 | Belgium | ⤷ Try a 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 |
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