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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 nineteen branded drugs marketed by Pfizer, Able, Alembic Pharms Ltd, Par Pharm, Galderma Labs Lp, Cosette, Fougera Pharms, Valeant Pharms North, Taro, Tolmar, Bausch, Perrigo Uk Finco, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, B Braun, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, Mylan Labs Ltd, Labs Af, Alembic Labs, 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 seventy-eight NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Metronidazole has forty-four patent family members in nineteen countries.
There are eighteen drug master file entries for metronidazole. Sixty suppliers are listed for this compound.
Summary for metronidazole
International Patents: | 44 |
US Patents: | 10 |
Tradenames: | 19 |
Applicants: | 49 |
NDAs: | 78 |
Drug Master File Entries: | 18 |
Suppliers / Packagers: | 60 |
Bulk Api Vendors: | 148 |
Clinical Trials: | 425 |
Patent Applications: | 7,405 |
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 |
---|---|
University of Lausanne | Phase 4 |
University of Karachi | Phase 1/Phase 2 |
The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510 | Phase 1/Phase 2 |
Pharmacology for metronidazole
Drug Class | Nitroimidazole Antimicrobial |
Medical Subject Heading (MeSH) Categories for metronidazole
Paragraph IV (Patent) Challenges for METRONIDAZOLE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
METROGEL | GEL;TOPICAL | metronidazole | 021789 | 2008-10-21 |
METROGEL-VAGINAL | GEL;VAGINAL | metronidazole | 020208 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | METRONIDAZOLE | metronidazole | TABLET;ORAL | 018599-001 | Sep 17, 1982 | DISCN | No | No | 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 | |||
Teva Pharms | VANDAZOLE | metronidazole | GEL;VAGINAL | 021806-001 | May 20, 2005 | BX | RX | No | Yes | Start Trial | Start Trial | Y | Start Trial | ||
B Braun | METRO I.V. IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 018900-001 | Sep 29, 1983 | AP | RX | Yes | Yes | Start Trial | Start Trial | 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 metronidazole
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 |
Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | Start Trial | Start Trial |
Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | Start Trial | Start Trial |
Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for metronidazole
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2013003646 | Start Trial |
Mexico | 2014000066 | Start Trial |
Russian Federation | 2004122696 | Start Trial |
Japan | 4611632 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for metronidazole
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 |
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