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Last Updated: July 3, 2022

NUVESSA Drug Patent Profile


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When do Nuvessa patents expire, and what generic alternatives are available?

Nuvessa is a drug marketed by Chemo Research Sl and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in nine countries.

The generic ingredient in NUVESSA 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nuvessa

A generic version of NUVESSA was approved as metronidazole by TEVA PHARMS USA on November 6th, 1984.

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Paragraph IV (Patent) Challenges for NUVESSA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NUVESSA Vaginal Gel metronidazole 1.30% 205223 1 2022-03-30

US Patents and Regulatory Information for NUVESSA

NUVESSA is protected by seven US patents.

Patents protecting NUVESSA

Aqueous-based metronidazole gel formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Aqueous-based metronidazole gel formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS

Compositions for increasing solubility of azole drug compounds that are poorly soluble in water
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL

Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing 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

International Patents for NUVESSA

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

Country Patent Number Title Estimated Expiration
Brazil 112013033759 formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana See Plans and Pricing
China 103763925 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis See Plans and Pricing
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) See Plans and Pricing
Japan 6235087 See Plans and Pricing
Japan 2017014248 高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用 (HIGH-DOSE MUCOADHESIVE METRONIDAZOLE AQUEOUS GEL PREPARATION, AND USE OF THE SAME FOR TREATING BACTERIAL VAGINOSIS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUVESSA

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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