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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-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 list18
Suppliers / Packaging: see list73
Therapeutic Class:Antibacterials
Drug Prices:see low prices

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
Watson Labs
METRONIDAZOLE
metronidazole
TABLET;ORAL018599-002Feb 13, 1984DISCNNo
Allergan Sales Llc
NUVESSA
metronidazole
GEL;VAGINAL205223-001Mar 24, 2014RXYes8,658,678Jun 27, 2028
Gd Searle Llc
FLAGYL
metronidazole
TABLET;ORAL012623-001Approved Prior to Jan 1, 1982RXNo
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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>
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 19884,837,378<disabled>
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 19925,840,744<disabled>
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International Patent Family for Ingredient: metronidazole

Country Document Number Estimated Expiration
Russian Federation2006116252<disabled in preview>
South Africa200405059<disabled in preview>
Canada2840571<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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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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