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. Seventy-three 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 6^th, 1984.

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Summary for NUVESSA

International Patents:	16
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	172
Patent Applications:	1,940
What excipients (inactive ingredients) are in NUVESSA?	NUVESSA excipients list
DailyMed Link:	NUVESSA at DailyMed

Drug patent expirations by year for NUVESSA

Pharmacology for NUVESSA

Drug Class	Nitroimidazole Antimicrobial

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water
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Patent Expiration: ⤷ Sign Up

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

Compositions for increasing solubility of azole drug compounds that are poorly soluble in water
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Patent Expiration: ⤷ Sign Up

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

Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL

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Glossary

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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	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Canada	3054236	FORMULATIONS DE GEL A BASE DE METRONIDAZOLE AQUEUX MUCOADHESIF A DOSAGE ELEVE ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTERIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS AND THEIR USE TO TREAT BACTERIAL VAGINOSIS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2009097143		⤷ Sign Up
Canada	2840571	FORMULATIONS DE GEL A BASE DE METRONIDAZOLE AQUEUX MUCOADHESIF A DOSAGE ELEVE ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTERIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS AND THEIR USE TO TREAT BACTERIAL VAGINOSIS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NUVESSA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium	⤷ Sign Up	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