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Last Updated: May 26, 2022

METROGEL Drug Patent Profile


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Which patents cover Metrogel, and what generic alternatives are available?

Metrogel is a drug marketed by Galderma Labs Lp and Bausch and is included in three NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in nineteen countries.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Drug patent expirations by year for METROGEL
Drug Prices for METROGEL

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Drug Sales Revenue Trends for METROGEL

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Paragraph IV (Patent) Challenges for METROGEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
METROGEL Topical Gel metronidazole 1% 021789 1 2008-10-21

US Patents and Regulatory Information for METROGEL

METROGEL is protected by two US patents.

Patents protecting METROGEL

Aqueous compositions containing metronidazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA

Aqueous compositions containing metronidazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 019737-001 Nov 22, 1988 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 METROGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 019737-001 Nov 22, 1988 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for METROGEL

See the table below for patents covering METROGEL around the world.

Country Patent Number Title Estimated Expiration
Hungary 904720 See Plans and Pricing
Denmark 0404376 See Plans and Pricing
Hungary 207795 PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITIONS FOR TREATING VAGINAL INFECTIONS CONTAINING METRONIDAZOL See Plans and Pricing
Australia 5829490 See Plans and Pricing
Hong Kong 1071514 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for METROGEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0328535 96C0021 Belgium See Plans and Pricing 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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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 verification 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.