NUVESSA Drug Patent Profile

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 6^th, 1984.

Summary for NUVESSA

International Patents:	16
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in NUVESSA?	NUVESSA excipients list
DailyMed Link:	NUVESSA at DailyMed

Pharmacology for NUVESSA

Drug Class

Nitroimidazole Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for NUVESSA

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01XD	Imidazole derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

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

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
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes			Y
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes			Y
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes

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
China	103763925	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis
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)
Japan	6235087
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)

Supplementary Protection Certificates for NUVESSA

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