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. Ten 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:	134
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

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	5,989,581

International Patents for NUVARING

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0876815
Australia	726934
Hungary	9800863

Supplementary Protection Certificates for NUVARING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629

NUVARING Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NuvaRing

Introduction

NuvaRing, a vaginal ring containing etonogestrel and ethinyl estradiol, is a popular combined hormonal contraceptive (CHC) used by women to prevent pregnancy. Here, we delve into the market dynamics and financial trajectory of NuvaRing, exploring its safety profile, market trends, and financial performance.

Safety Profile and Efficacy

NuvaRing has a well-documented safety profile and efficacy. Studies, including the Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC) and an FDA-funded retrospective cohort study, have shown that the risk of venous thromboembolic events (VTEs) for new users of NuvaRing is similar to that of combined oral contraceptives (COCs)[1].

Regulatory Updates and Labeling

The FDA-approved patient information and physician package labeling for NuvaRing include warnings about the increased risk of serious cardiovascular events, particularly in women who smoke. These labels were updated in 2013 to reflect the findings from recent studies[1].

Market Trends

The market for vaginal rings, including NuvaRing, is poised for significant growth. Projections indicate a strong expansion from 2023 to 2031, driven by increasing demand for convenient and effective contraceptive options[3].

Competitive Landscape

The introduction of generic versions of NuvaRing has altered the competitive landscape. Teva Pharmaceuticals launched a generic version of NuvaRing in the U.S. in 2021, providing an alternative to the branded product. This move has increased accessibility and competition in the market[4].

Financial Performance

NuvaRing generates substantial revenue. As of 2020, etonogestrel and ethinyl estradiol vaginal ring products, including NuvaRing, had annual sales of over $837 million in the U.S.[4].

Organon's Financials

Organon, the company behind NuvaRing, has reported steady financial performance. In the fourth quarter of 2023, Organon's total revenue was $1.598 billion, an increase of 8% compared to the same period in 2022. The company's net income for 2023 was $1.0 billion, or $3.99 per diluted share[2].

Quarterly Performance

In the first quarter of 2024, Organon's net income was $201 million, or $0.78 per diluted share, with a non-GAAP Adjusted net income of $315 million, or $1.22 per diluted share. The company's gross margin was 59.0% on an as-reported basis and 62.1% on a non-GAAP adjusted basis[5].

Revenue and Market Share

The Established Brands segment of Organon, which includes NuvaRing, saw a 3% increase in revenue in the fourth quarter of 2023. This growth is indicative of the product's continued market presence and demand[2].

Litigation and Settlements

Merck, the original developer of NuvaRing, resolved product liability claims related to the product in 2014. The company agreed to pay $100 million to settle the claims, with insurance coverage funding the settlement. This resolution did not admit wrongdoing but helped to mitigate legal risks associated with the product[1].

Market Outlook

The vaginal ring market, driven by products like NuvaRing, is expected to see significant growth due to its convenience, efficacy, and increasing acceptance. Market dynamics, including drivers such as growing demand for hormonal contraceptives and restraints like regulatory scrutiny, will shape the future of this market[3].

Key Takeaways

• Safety and Efficacy: NuvaRing has a well-documented safety profile with risks similar to COCs.
• Market Growth: The market for vaginal rings is projected to expand significantly from 2023 to 2031.
• Competitive Landscape: The introduction of generic versions has increased competition.
• Financial Performance: NuvaRing generates substantial revenue, contributing to Organon's financial stability.
• Regulatory Compliance: Labels have been updated to reflect recent study findings.

FAQs

Q: What is the primary active ingredient in NuvaRing? A: NuvaRing contains etonogestrel and ethinyl estradiol.

Q: What are the main risks associated with using NuvaRing? A: The main risks include an increased risk of venous thromboembolic events (VTEs) and serious cardiovascular events, especially in women who smoke.

Q: Has a generic version of NuvaRing been launched? A: Yes, Teva Pharmaceuticals launched a generic version of NuvaRing in the U.S. in 2021.

Q: How has the market for vaginal rings been performing? A: The market is expected to see significant growth from 2023 to 2031 due to increasing demand for convenient and effective contraceptive options.

Q: What was the annual sales figure for NuvaRing and similar products in the U.S. as of 2020? A: The annual sales figure was over $837 million.

Sources

1. Merck Stands Behind the Safety Profile of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring)
2. Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2023
3. Market Research Intellect - Global Vaginal Rings Market
4. Teva Announces Launch of a Generic Version of NuvaRing® (etonogestrel and ethinyl estradiol) Vaginal Ring in the United States
5. Organon Reports Results for the First Quarter Ended March 31, 2024