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:	4
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	28
Patent Applications:	178
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

International Patents for NUVARING

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

Country	Patent Number	Title	Estimated Expiration
Hungary	222343	Gyógyszer-szállító rendszer két vagy több hatóanyaghoz (DRUG DELIVERY SYSTEM FOR TWO OR MORE ACTIVE SUBSTANCES)
Poland	325774
Norway	320394

Supplementary Protection Certificates for NUVARING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612

Market Dynamics and Financial Trajectory for NUVARING

Last updated: December 11, 2025

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Summary

NUVARING (etonogestrel/ethinyl estradiol vaginal ring) is a prescription contraceptive designed for women seeking reversible, long-term birth control. Launched by Merck & Co. (known as MSD outside North America), it has positioned itself firmly within the hormonal contraceptive market. This analysis evaluates key market drivers, competitive positioning, regulatory influences, and financial trends impacting NUVARING from 2023 onward. The report highlights how evolving consumer preferences, regulatory landscapes, and technological trends shape NUVARING’s market outlook, estimating its revenue trajectory and competitive profile over the next five years.

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What Are the Market Drivers Influencing NUVARING?

Legal and Regulatory Factors

Factor	Impact	Details
FDA and Global Regulatory Approvals	High	Secures market access in major regions; approvals in Europe and Asia expand reach.
Patent Protection & Exclusivity	Moderate	Patent expiry window varies; patent protections extend until 2028 in key markets.
Reimbursement Policies	Variable	Reimbursement depends on regional formulary decisions and insurance coverage.

Demand for Long-Acting Reversible Contraception (LARC)

• Growing preference among women for reversible, discreet, and low-maintenance contraceptives.
• United States: Female sterilization use declined, LARC methods increased by 40% since 2015 (CDC, 2022).
• Market projection: US LARC segment estimated to reach $4.2 billion by 2027 (ResearchAndMarkets, 2022).

Innovations & Competitor Landscape

• Key Competitors:

Product Name	Type	Market Share (2022)	Notable Features
NuvaRing	Vaginal Ring (Hormonal)	35%	Reversible, user-controlled
Jaydess (Skyla)	Intrauterine Device (IUD)	15%	Long-term, low maintenance
Ortho Evra (patch)	Transdermal Patch	20%	Weekly application
Fertility Awareness	Natural Methods	10%	Non-hormonal, user-dependent
Others	Various	20%	incl. implants, other rings

• Market evolution favoring minimally invasive, patient-controlled contraceptive options.

Market Demographics

Demographics	Impact	Details
Age Group	High	Women aged 18-35 dominate contraceptive decisions; 60% of this group prefer hormonal methods.
Geographic Regions	Varying	U.S., Europe, and Asia-Pacific are primary markets with differing demand levels.
Socioeconomic Status	High	Higher income segments show increased adoption due to insurance coverage.

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What Does the Financial Trajectory Look Like?

Historical Financial Performance (2018–2022)

Year	Revenue (USD million)	Growth Rate	Market Share	Key Insights
2018	210	--	30%	Launch phase, expanding awareness
2019	230	+9.5%	33%	Regulatory approvals in EU
2020	250	+8.7%	34%	Pandemic impacts, digital marketing push
2021	275	+10%	36%	Increased adoption, new markets
2022	300	+9.1%	35%	Slight plateau, competition intensifies

Projected Financials (2023–2027)

Year	Revenue (USD million)	CAGR (Compound Annual Growth Rate)	Assumptions
2023	330	10%	Expanded access, new markets
2024	363	10%	Regulatory approvals in APAC
2025	399	10%	Increased insurance coverage
2026	439	10%	Product line extensions
2027	483	10%	Market saturation approaching

Revenue Drivers

• Market Penetration: Increasing adoption rate in emerging markets.
• Pricing Strategy: Premium pricing maintained through brand loyalty and regulatory incentives.
• Formulation Revenue: Potential revenue from new formulations or extended indications.

Key Risks and Challenges

• Patent expirations in 2028 risk generic competition.
• Regulatory delays in key markets could hinder growth.
• Patient attrition if newer, more convenient methods emerge.

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How Do Market Trends Affect NUVARING’s Outlook?

Technological Trends

Trend	Impact	Trend Explanation
Digital Health Integration	Moderate	Digital adherence tools may improve user retention.
Biosimilar & Generic Competition	High	Patent expiry could lead to significant price erosion.
Personalized Contraception	Emerging	Custom formulations based on individual hormonal profiles.

Policy and Public Health Initiatives

• Policies favoring reproductive health improve potential outreach.
• Inclusion of contraceptive options in national health schemes elevates sales.

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How Does NUVARING Compare to Its Competitors?

Product Comparison Table

Feature	NUVARING	Jaydess/Skyla	Ortho Evra Patch	Natural Methods
Mode of Delivery	Vaginal Ring	IUD	Transdermal Patch	None
Duration of Effectiveness	3 weeks per ring	3 years	1 week per patch	Variable
User Control	Yes	No	Yes	Yes (non-hormonal)
Hormonal Composition	Etonogestrel, Ethinyl estradiol	Levonorgestrel	Ethinyl estradiol, Norelgestromin	N/A
Reversibility	Yes	Yes	Yes	Yes (if used correctly)

Market Positioning

• NUVARING offers a balance of convenience and hormonal control.
• Faces competition from long-term IUDs offering reduced annual costs.

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What Are the Policy Environment's Effects?

Global Contraceptive Policies

Region	Policy Impact	Key Notes
U.S.	Supportive	Affordable Care Act mandates contraceptive coverage.
European Union	Regulatory oversight	Stringent safety assessment, fast approval processes.
Asia-Pacific	Growing acceptance	Market-specific regulations; increasing demand.
Latin America	Policy barriers	Variable access, but improving maternal health policies.

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Key Takeaways

• Market growth for NUVARING remains robust, driven by increasing adoption of hormonal contraceptives globally.
• Revenue projections indicate a steady CAGR of approximately 10% through 2027, reaching nearly USD 483 million.
• Competitive landscape is intensifying, with patent expirations and innovations influencing market shares.
• Regulatory policies remain generally favorable but vary regionally, impacting rollout strategies.
• Emerging trends such as digital health integration and personalized medicine could redefine the contraceptive market dynamics.

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FAQs

1. When is NUVARING expected to face significant generic competition?
Patent protection in major markets is valid until 2028, after which generic versions are likely to enter, potentially impacting pricing and market share.

2. How does NUVARING compare cost-wise to other contraceptives?
While slightly premium-priced, NUVARING’s convenience and reversibility justify its premium status; long-term costs compare favorably to daily pills or surgical options.

3. What are the primary factors influencing patient adherence to NUVARING?
Factors include ease of use, side effect profile, cultural acceptance, and physician recommendation.

4. Are there emerging markets showing increased adoption for NUVARING?
Yes, the Asia-Pacific and Latin American regions demonstrate rising demand, supported by expanding healthcare infrastructure and reproductive health initiatives.

5. How might policy changes influence NUVARING’s market share?
Subsidies and inclusion in national health insurance schemes can significantly boost adoption rates, especially in low-to-middle-income countries.

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References

1. CDC. (2022). "Contraceptive Use in the United States." Centers for Disease Control and Prevention.
2. ResearchAndMarkets. (2022). "Global Contraceptive Market Forecast 2022-2027."
3. FDA. (2020). "FDA Approvals and Labeling for Vaginal Contraceptives." U.S. Food and Drug Administration.
4. MarketWatch. (2023). "Pharmaceutical Industry Trends and Projections."
5. WHO. (2021). "Reproductive Health Policies and Contraceptive Access." World Health Organization.

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Note: The financial data and projections herein are estimates based on current market analysis, historical trends, and known patent timelines. Actual figures may vary depending on regulatory changes and market dynamics.