Etonogestrel - Generic Drug Details

What are the generic drug sources for etonogestrel and what is the scope of freedom to operate?

Etonogestrel is the generic ingredient in two branded drugs marketed by Organon and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etonogestrel has one hundred and five patent family members in thirty-five countries.

There are five drug master file entries for etonogestrel. One supplier is listed for this compound.

Summary for etonogestrel

International Patents:	105
US Patents:	4
Tradenames:	2
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	78
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for etonogestrel
What excipients (inactive ingredients) are in etonogestrel?	etonogestrel excipients list
DailyMed Link:	etonogestrel at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for etonogestrel

Constraining patent/regulatory exclusivity:

8,722,037

Dosage:

IMPLANT;IMPLANTATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for etonogestrel

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE2
Yale University	PHASE2
Mata Poli de Arajo	EARLY_PHASE1

See all etonogestrel clinical trials

Pharmacology for etonogestrel

Drug Class

Progestin

Anatomical Therapeutic Chemical (ATC) Classes for etonogestrel

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

Paragraph IV (Patent) Challenges for ETONOGESTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXPLANON	Implant	etonogestrel	68 mg	021529	1	2024-12-31

US Patents and Regulatory Information for etonogestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	8,722,037		Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	9,757,552		Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	10,821,277		Y
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006		DISCN	No	No	9,757,552		Y

Expired US Patents for etonogestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006	4,957,119
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006	5,150,718

International Patents for etonogestrel

Country	Patent Number	Title	Estimated Expiration
Ukraine	89518	АППЛИКАТОР ДЛЯ ВВЕДЕНИЯ ИМПЛАНТАТА;АПЛІКАТОР ДЛЯ ВВЕДЕННЯ ІМПЛАНТАТА (APPLICATOR FOR INSERTING AN IMPLANT)
European Patent Office	3417905	DISPOSITIF POUR INSÉRER UN IMPLANT (APPLICATOR FOR INSERTING AN IMPLANT)
European Patent Office	1984063
China	101370550

Supplementary Protection Certificates for etonogestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0303306	C980027	Netherlands		PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825
0303306	099C0041	Belgium		PRODUCT NAME: ETONOGESTREL; NATL. REGISTRATION NO/DATE: 52 IS 296 F 14 19990531; FIRST REGISTRATION: NL RVG 21168 19980825
0303306	SPC/GB99/044	United Kingdom		PRODUCT NAME: ETONOGESTREL; REGISTERED: NL RGV21168 19980825; UK 00065/0161 19990609
0303306	29/1999	Austria		PRODUCT NAME: ETONOGESTREL; NAT. REGISTRATION NO/DATE: 1-22964 19990330; FIRST REGISTRATION: NL 21168 19980825

Market Dynamics and Financial Trajectory for Etonogestrel

Last updated: July 31, 2025

Introduction

Etonogestrel, a synthetic progestin primarily used as a hormonal contraceptive, has carved a significant niche within the reproductive health market. Its distinctive pharmacological profile as a long-acting reversible contraceptive (LARC) agent has driven sustained demand, coupled with evolving market dynamics influenced by regulatory, technological, and societal shifts. This article delineates the current state, underlying drivers, and future financial trajectory of etonogestrel, providing stakeholders with comprehensive insights to inform strategic decision-making.

Pharmacological Profile and Market Applications

Etonogestrel is marketed predominantly as its contraceptive implant, Nexplanon/Implanon, and as an vaginal ring, NuvaRing. The implant, consisting of a small rod inserted subdermally, releases a steady dose of etonogestrel, providing contraception for up to three years. The vaginal ring offers monthly contraception, emphasizing convenience and adherence.

The rising preference for LARCs over traditional hormonal methods stems from their high efficacy, low maintenance, and reversibility. Reports from the World Health Organization (WHO) highlight LARCs’ superior efficacy rates (>99%) and low discontinuation rates, propelling market growth ([1]).

Market Drivers

1. Increasing Demand for Long-Acting Reversible Contraceptives

The global move towards long-term, user-independent contraceptive solutions has bolstered etonogestrel-based products’ adoption. According to the Guttmacher Institute, LARCs are increasingly favored in both developed and emerging markets, especially among women seeking highly effective, discreet contraceptive options ([2]).

2. Rising Female Population and Awareness

Population growth, coupled with targeted awareness campaigns about reproductive health, elevates demand. The United Nations reports an expanding reproductive-age female demographic, fueling sales of contraceptive products, including etonogestrel implants and rings.

3. Regulatory Approvals and Expanding Indications

Major regulatory approvals, particularly by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have facilitated market penetration. The approval of new formulations with improved safety profiles continues to bolster uptake.

4. Strategic Collaborations and Product Innovations

Pharmaceutical companies are engaging in partnerships, expanding distribution networks, and investing in product innovations such as biodegradable implants. This sustains competitive advantage and access to emerging markets.

5. Favorable Reimbursement Policies

Insurance coverage and reimbursement schemes in countries like the U.S. and members of the European Union incentivize providers and consumers to opt for etonogestrel-based contraceptives, reducing out-of-pocket expenses.

Market Challenges

1. Competition from Other Contraceptive Modalities

Oral contraceptives, intrauterine devices (IUDs), and other non-hormonal methods pose competition, especially as some patients prefer non-implant options due to personal or cultural reasons.

2. Side Effect Profile and Contraindications

Adverse effects, such as irregular bleeding, weight gain, and hormonal side effects, can deter usage. Stringent contraindications limit applicability in certain populations.

3. Patent Expirations and Generic Entry

Expiring patents threaten profit margins, prompting patent cliffs and exposing markets to generic alternatives, which usually exert price pressure ([3]).

4. Regulatory and Reimbursement Barriers in Emerging Markets

Regulatory delays, lack of reimbursement, and cultural barriers hinder market penetration in regions like Africa, Southeast Asia, and Latin America.

Financial Trajectory and Market Outlook

Market Size and Growth Forecasts

The global contraceptive market was valued at approximately USD 21 billion in 2022, with the segment of hormonal contraceptives including etonogestrel projected to grow at a CAGR of around 6% through 2028 ([4]).

Etonogestrel implant sales alone are expected to reach USD 1.2 billion by 2025, driven by rising adoption rates in North America and Europe, and expanding access initiatives in emerging markets ([5]).

Similarly, the vaginal ring segment, adjunct to implant sales, is anticipated to generate USD 300 million globally by 2025, with compound growth driven by product innovation and patient preference for monthly dosing.

Revenue Streams and Profitability

Major pharmaceutical players, such as Merck (with Nexplanon), generate substantial revenue from sales of etonogestrel products. The high-margin nature of LARCs accentuates profitability, particularly with patent protections maintaining market dominance.

Post-patent expiry, revenue contraction is expected, unless manufacturers can pivot to biosimilars or new delivery platforms. Additionally, subscription-based reproductive health services and direct-to-consumer sales are emerging revenue channels.

Impact of Patent Expiry and Biosimilar Competition

Patent expirations for key etonogestrel products are anticipated around 2024–2026. Entry of biosimilars and generics could reduce prices by 20–30%, significantly impacting profit margins ([6]).

Companies investing in next-generation delivery systems—such as biodegradable implants and technology-driven adherence solutions—aim to sustain revenue streams amid generic competition.

Market Expansion Potential

Emerging markets, such as India, Nigeria, and Brazil, present accelerated growth opportunities—supported by increasing healthcare infrastructure, rising awareness, and governmental initiatives promoting family planning.

The WHO’s inclusion of contraceptives in essential medicines lists further encourages procurement and distribution in low-income countries.

Future Investment and Innovation Trends

Innovation investments focus on enhancing user experience, reducing side effects, and expanding indications to conditions like menorrhagia and endometrial hyperplasia. Developing combination products, integrating hormonal contraceptives with other therapeutics, offers additional revenue streams.

Furthermore, digital health integration—such as adherence tracking apps—may improve product efficacy and customer retention, fostering long-term revenue growth.

Regulatory and Market Dynamics Impact

Regulatory approvals will continue influencing growth trajectories. Countries adopting policies favoring LARCs and reimbursing contraceptive services will experience accelerated adoption rates. Conversely, restrictive policies or shifts in funding for reproductive health could dampen expansion opportunities.

Monitoring patent landscapes and biosimilar developments will be crucial for revenue forecasting. Patent cliffs, scheduled around 2024–2026, are likely to reshape competitive dynamics, potentially reducing prices but also compelling innovation-driven differentiation.

Key Market Players

• Merck & Co., Inc.: Dominates with Nexplanon; strong manufacturing and distribution network.

• CooperSurgical, Inc.: Offers alternative implant devices competing in emerging markets.

• Organon & Co.: Producer of hormonal contraceptives, including etonogestrel-based products.

Their strategies involve patent protection, product innovation, and geographic expansion to secure market share.

Conclusion

Etonogestrel’s market landscape is poised for continued growth, driven by demographic trends, evolving contraceptive preferences, and expanding markets in developing regions. While patent expirations present challenges, innovation and strategic alliances are critical for sustaining profitability.

Investment in R&D, personalized medicine approaches, and digital integration will define the financial trajectory. Stakeholders should monitor regulatory shifts and competitor developments to optimize market positioning and revenue streams.

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Key Takeaways

• Etonogestrel remains a cornerstone in LARC contraceptive options, with strong global demand especially among women seeking long-term, effective, reversible contraception.

• Growth is primarily driven by demographic expansion, increasing awareness, regulatory approvals, and reimbursement support in mature markets.

• Patent expirations around 2024–2026 could pressure pricing and margins, emphasizing the importance of product innovation and pipeline development.

• Emerging markets present significant revenue opportunities; however, regulatory and infrastructural barriers require strategic engagement.

• Continuous innovation—biodegradable implants, digital health tools, and expanded indications—will be critical to maintaining a competitive advantage and ensuring sustained revenues.

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FAQs

Q1: What are the primary commercial segments for etonogestrel products?
Etonogestrel's main commercial segments include contraceptive implants (e.g., Nexplanon/Implanon) and vaginal rings (e.g., NuvaRing). These segments benefit from high efficacy and user preference for long-acting, reversible contraception.

Q2: How do patent expirations affect the financial prospects of etonogestrel products?
Patent expirations around 2024–2026 risk opening markets to generic and biosimilar entrants, which typically lead to significant price reductions and profit margin compression. This necessitates innovation and diversification strategies to maintain revenue.

Q3: Which markets offer the highest growth potential for etonogestrel?
Emerging markets such as India, Nigeria, and Brazil hold substantial growth potential due to rising contraceptive demand, increasing healthcare infrastructure, and supportive government initiatives.

Q4: What technological advancements are shaping the future of etonogestrel delivery?
Innovation trends include biodegradable implants reducing environmental impact, digital adherence monitoring, and combination delivery systems expanding indications and enhancing patient engagement.

Q5: What are the main challenges facing etonogestrel market expansion?
Key challenges encompass competition from other contraceptive methods, side-effect concerns, regulatory and reimbursement hurdles in certain regions, and patent-related price competition.

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References

[1] WHO. Family Planning/Contraception: Long-acting Reversible Contraceptives (LARCs). 2020.
[2] Guttmacher Institute. Facts on Family Planning. 2018.
[3] IQVIA. The Global Use of Medicines in 2022.
[4] MarketWatch. Contraceptive Market Size & Growth Forecast. 2022.
[5] EvaluatePharma. Top-selling contraceptive products forecast. 2023.
[6] Statista. Patent expiration impacts on pharmaceuticals. 2022.