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NUVARING Drug Profile

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

Nuvaring is a drug marketed by Organon Sub Merck 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. Five 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:	1
Clinical Trials:	26
Patent Applications:	1
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
Andrea Roe, MD, MPH	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4

See all NUVARING clinical trials

Pharmacology for NUVARING

Drug Class	Progestin Estrogen
Mechanism of Action	Estrogen Receptor Agonists

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	NDA	Submissiondate
NUVARING	RING;VAGINAL	ethinyl estradiol; etonogestrel	021187	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 Sub Merck	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 Sub Merck	NUVARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	021187-001	Oct 3, 2001

International Patents for NUVARING

Country	Patent Number	Estimated Expiration
Taiwan	358031
Germany	69803112
Japan	4982670

Supplementary Protection Certificates for NUVARING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811