NUVARING Drug Patent Profile

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

Nuvaring is a drug marketed by Organon Usa Organon and is included in one NDA.

The generic ingredient in NUVARING is ethinyl estradiol; etonogestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nuvaring

A generic version of NUVARING was approved as ethinyl estradiol; etonogestrel by TEVA PHARMS USA INC on January 13^th, 2021.

Summary for NUVARING

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	28
Patent Applications:	169
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NUVARING
Drug Sales Revenues:	Drug sales revenues for NUVARING
What excipients (inactive ingredients) are in NUVARING?	NUVARING excipients list
DailyMed Link:	NUVARING at DailyMed

See drug prices for NUVARING

See drug sales revenues for NUVARING

Recent Clinical Trials for NUVARING

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lupin Research Inc	Phase 2
Andrea Roe, MD, MPH	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4

See all NUVARING clinical trials

Pharmacology for NUVARING

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for NUVARING

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for NUVARING

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUVARING	Vaginal Ring	ethinyl estradiol; etonogestrel	0.015 mg/24 hour 0.12 mg/24 hour	021187	1	2013-06-17

US Patents and Regulatory Information for NUVARING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Organon	NUVARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	021187-001	Oct 3, 2001	AB	RX	Yes	Yes

Expired US Patents for NUVARING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	NUVARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	021187-001	Oct 3, 2001

International Patents for NUVARING

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

Country	Patent Number	Title	Estimated Expiration
Australia	6075198
Brazil	9801027	sistema de distribuiÇço de medicamentos.
Denmark	0876815
Japan	H10287549	DRUG DELIVERY SYSTEM FOR TWO OR MORE KINDS OF ACTIVE SUBSTANCES
Portugal	876815
Hungary	9800863
Norway	981638

Supplementary Protection Certificates for NUVARING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211