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Metronidazole - Generic Drug Details

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Metronidazole is the generic ingredient in nineteen branded drugs marketed by B Braun, Galderma Labs Lp, Tolmar, Intl Medication, Able, Teva Pharms, Eurohlth Intl Sarl, Fougera Pharms, Medicis, Superpharm, Flamingo Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Taro, Sandoz, Halsey, Par Pharm, Alembic Ltd, Allergan Sales Llc, Gd Searle Llc, Labs Af, Teva Pharms Usa, LNK, Savage Labs, Pliva, Watson Labs, Vivimed Labs, Valeant Pharms North, Watson Labs Inc, Appco Pharma Llc, G And W Labs, Pfizer, Baxter Hlthcare, Unichem Labs Ltd, Strides Pharma, Alembic Pharms Ltd, Abraxis Pharm, Ortho Mcneil Pharm, Nostrum Labs Inc, Aurobindo Pharma Ltd, G And W Labs Inc, Claris, Abbott, and Hospira, and is included in seventy NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-six patent family members in nineteen countries.

There are eighteen drug master file entries for metronidazole. Seventy-two suppliers are listed for this compound.

Summary for Generic Name: metronidazole

Tradenames:19
Patents:8
Applicants:44
NDAs:70
Drug Master File Entries: see list18
Suppliers / Packaging: see list72
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for Ingredient: metronidazole

Clinical Trials for: metronidazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Able
METRONIDAZOLE
metronidazole
CAPSULE;ORAL076505-001Nov 13, 2003DISCNNo<disabled><disabled>
Ivax Sub Teva Pharms
METRONIDAZOLE
metronidazole
TABLET;ORAL018517-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Mutual Pharm
METRONIDAZOLE
metronidazole
TABLET;ORAL018818-002Feb 16, 1983DISCNNo<disabled><disabled>
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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;VAGINAL020208-001Aug 17, 19924,837,378<disabled>
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 19925,840,744<disabled>
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 19925,536,743<disabled>
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International Patent Family for Ingredient: metronidazole

Country Document Number Estimated Expiration
Brazil0215331<disabled in preview>
European Patent Office1467744<disabled in preview>
European Patent Office2241320<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
C0021Belgium<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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