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
Czech Republic	9801102
South Africa	9802911
Indonesia	21259
Hungary	222343	Gyógyszer-szállító rendszer két vagy több hatóanyaghoz (DRUG DELIVERY SYSTEM FOR TWO OR MORE ACTIVE SUBSTANCES)
Denmark	0876815
Spain	2171283
Poland	192449

Supplementary Protection Certificates for NUVARING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612