NEXPLANON Drug Patent Profile

Which patents cover Nexplanon, and what generic alternatives are available?

Nexplanon is a drug marketed by Organon and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NEXPLANON is etonogestrel. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the etonogestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Nexplanon

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NEXPLANON

International Patents:	105
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	29
Patent Applications:	2,304
Drug Prices:	Drug price information for NEXPLANON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXPLANON
What excipients (inactive ingredients) are in NEXPLANON?	NEXPLANON excipients list
DailyMed Link:	NEXPLANON at DailyMed

See drug prices for NEXPLANON

Recent Clinical Trials for NEXPLANON

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

Sponsor	Phase
Oregon Health and Science University	Early Phase 1
University of Saskatchewan	Phase 2
Saskatchewan Health Authority - Regina Area	Phase 2

See all NEXPLANON clinical trials

Pharmacology for NEXPLANON

Drug Class

Progestin

Paragraph IV (Patent) Challenges for NEXPLANON

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

US Patents and Regulatory Information for NEXPLANON

NEXPLANON is protected by four US patents.

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			Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes			Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes			Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes			Y

International Patents for NEXPLANON

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1729819
Ireland	882118
Brazil	PI0606826	aplicador para inserir um implante
Ireland	61730	Contraceptive implant
South Korea	20070112144	APPLICATOR FOR INSERTING AN IMPLANT
Hong Kong	1002020
Russian Federation	2384347	УСТРОЙСТВО ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ, ВИДИМОЕ В РЕНТГЕНОВСКИХ ЛУЧАХ (X-RAY VISIBLE DRUG DELIVERY DEVICE)

Supplementary Protection Certificates for NEXPLANON

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

Market Dynamics and Financial Trajectory for NEXPLANON

Last updated: August 25, 2025

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Introduction

NEXPLANON, a long-acting reversible contraceptive implant manufactured by Merck & Co., Inc., has established itself as a principal product within the contraceptive market. Its combination of efficacy, convenience, and minimally invasive administration has driven its adoption globally. Comprehending its market dynamics and financial outlook is essential for stakeholders, investors, and healthcare providers navigating the evolving reproductive health sector.

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Product Overview and Market Position

NEXPLANON, a subdermal implant releasing etonogestrel over three years, was first approved by the U.S. Food and Drug Administration (FDA) in 2012. Its mechanism involves continuous hormone delivery, suppressing ovulation and thickening cervical mucus, resulting in highly effective contraception.

Key benefits underpinning NEXPLANON's market positioning include:

• Efficacy: >99% effectiveness comparable to permanent sterilization.
• Duration: Provides protection for up to three years.
• User Convenience: Eliminates daily compliance, a significant advantage over oral contraceptives.
• Reversibility: Rapid fertility return upon removal.

The implant targets a broad demographic, spanning adolescents to adults seeking reliable, low-maintenance contraception.

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Market Dynamics Influencing NEXPLANON

Growing Global Demand for Long-Acting Reversible Contraceptives (LARCs)

The expanding preference for LARCs is a critical driver. WHO reports illustrate that LARCs' global usage has increased over the past decade, especially in developing nations due to urbanization, improved healthcare access, and heightened awareness of family planning options.

According to the Guttmacher Institute, approximately 24% of contraceptive users worldwide rely on LARCs, a figure projected to rise owing to concerted governmental and NGO initiatives. This trend benefits NEXPLANON's market growth, especially in emerging markets where surgical sterilization remains less accessible.

Regulatory Landscape and Market Expansion

The approval of NEXPLANON across various jurisdictions enhances its market potential. Notably:

• United States: FDA approval in 2012 catalyzed widespread adoption.
• Europe: CE marking facilitated access within the EU.
• Asia-Pacific & Africa: Emerging approvals are expanding reach, supported by partnerships with governments and non-profit agencies aimed at reducing unintended pregnancy rates.

Regulatory developments often align with increased insurance coverage and inclusion in national family planning programs, further boosting adoption rates.

Competitive Landscape

NEXPLANON faces competition from other LARCs, such as:

• hormonal intrauterine devices (IUDs): Mirena, Kyleena
• other implants: Norplant, Jadelle

Despite competitors, NEXPLANON's unique profile—such as ease of insertion/removal and robust efficacy—maintains its market share. The advent of newer delivery systems and formulations poses potential challenges however.

Market Penetration and Adoption Barriers

Barriers include:

• Cost considerations: High upfront costs, often borne by healthcare systems or patients.
• Cultural and provider biases: Preference for short-term methods in some regions.
• Limited awareness: Educational gaps may hinder adoption, especially in low-resource settings.

Efforts to address these barriers include subsidization programs, provider training, and patient education.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since its launch, NEXPLANON's sales have steadily increased, driven by expanding indications and global market penetration. Merck's fiscal reports estimate that NEXPLANON contributed significantly to the contraceptive revenue segment.

For example, in 2021, global sales from NEXPLANON and similar devices surpassed $1.2 billion, representing a compounded annual growth rate (CAGR) of approximately 5-7% over the previous five years, when accounting for market expansion and innovation.

Forecasted Growth and Contributing Factors

Analysts project sustained growth in the coming years, leveraging:

• Expanding markets: Adoption in Asia-Pacific, Latin America, and Africa.
• Product enhancements: Variants with adjusted hormone doses and improved insertion tools.
• Healthcare policies: Increasing emphasis on family planning initiatives.

According to industry reports, the contraceptive implant market is expected to grow at a CAGR of around 6% until 2030, with NEXPLANON poised to capture a substantial share due to its established position and ongoing product pipeline.

Impact of Patent Expiry and Generics

While Merck retains exclusivity in key markets, patent expirations and biosimilar entries could influence pricing and revenues, necessitating strategies like product line extensions and market diversification.

Pricing and Reimbursement Trends

Pricing strategies vary globally, influenced by regulatory policies and insurance reimbursements. Regions with universal healthcare tend to offer favorable reimbursement, bolstering sales. Conversely, high out-of-pocket costs in some markets may limit access, affecting revenue growth.

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Future Market Drivers and Challenges

Innovation and Pipeline Development

Merck and competitors continue developing next-generation implants, aiming to:

• Enhance duration (e.g., 5-year implants).
• Reduce insertion/removal discomfort.
• Incorporate alternative hormone formulations.

Such innovations are anticipated to revitalize interest and extend the product lifecycle, positively impacting revenue streams.

Potential Disruptors

Emerging contraceptive methods—such as injectable hormonal agents, non-hormonal options, and digital fertility tracking—may reshape the niche market of LARCs, posing future challenges.

Market Risks

Key risks include:

• Regulatory hurdles in developing markets.
• Political or cultural opposition.
• Supply chain disruptions.
• Healthcare provider biases.

Mitigating these risks involves strategic partnerships, targeted educational campaigns, and adaptive pricing models.

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Conclusion and Outlook

NEXPLANON’s market dynamics are characterized by favorable demographic trends, expanding global access to LARCs, and ongoing innovation within contraceptive technology. Financially, it remains a lucrative segment for Merck, with forecasts indicating steady growth driven by emerging markets and product enhancements.

However, competitive pressures, patent considerations, and evolving consumer preferences necessitate continual innovation and market adaptation. Stakeholders that prioritize educational initiatives, market diversification, and product pipeline investments are best positioned to capitalize on the forecasted trajectory.

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Key Takeaways

• Growth Catalysts: Rising demand for long-term, reversible contraception globally ensures strong demand for NEXPLANON.
• Market Expansion: Increasing approvals and healthcare initiatives in emerging markets will boost sales.
• Revenue Stability: NEXPLANON’s established efficacy and convenience secure its role as a high-margin product for Merck.
• Innovation Drive: Next-gen implants and formulation improvements will sustain competitive advantage.
• Strategic Risks: Patent expirations, regulatory challenges, and cultural barriers must be proactively managed.

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FAQs

1. How does NEXPLANON compare to other contraceptive methods in terms of efficacy?
NEXPLANON boasts over 99% effectiveness, matching the efficacy of sterilization but offering reversibility and long-term use, making it highly competitive among contraceptive options.

2. What are the primary barriers to NEXPLANON's widespread adoption?
Cost, lack of awareness, provider training constraints, and cultural factors influence adoption, particularly in resource-limited regions.

3. How might patent expirations affect NEXPLANON's financial outlook?
Patent expirations could introduce biosimilars, potentially reducing prices and margins. Merck’s response involves product innovation and diversification.

4. What markets hold the most promise for NEXPLANON’s growth over the next decade?
Asia-Pacific, Africa, and Latin America are pivotal due to demographic trends, increasing healthcare access, and rising contraceptive demand.

5. Are there any upcoming innovations that could influence NEXPLANON’s competitive landscape?
Yes, upcoming longer-duration implants, hormone-free options, and user-friendly insertion technologies are in development, likely shaping future market dynamics.

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Sources

1. Guttmacher Institute. (2021). Global Trends in Contraceptive Use.
2. FDA. (2012). FDA Approval Letter for NEXPLANON.
3. Merck & Co., Inc.. (2022). Annual Reports and Market Data.
4. World Health Organization. (2020). Family Planning/Contraceptive Use Reports.
5. Industry Reports. (2022). Contraceptive Devices Market Forecast.