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
Yale University	PHASE2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	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	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006		DISCN	No	No	9,757,552		Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	8,888,745		Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	8,722,037		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
Latvia	13521	X-RAY VISIBLE DRUG DELIVERY DEVICE
Australia	2005224054	X-ray visible drug delivery device
Taiwan	I434676

Supplementary Protection Certificates for etonogestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0303306	C980027	Netherlands		PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825

Market Dynamics and Financial Trajectory for Etonogestrel

Last updated: February 20, 2026

Etonogestrel is a synthetic progestin used primarily in contraceptive products. It is marketed in different formulations, including subdermal implants and vaginal rings. The global market for etonogestrel is influenced by regulatory approval, patent protections, competition, and healthcare policies.

Market Overview

Etonogestrel's primary application is in contraception, with products such as Norplant (discontinued) and Nexplanon/Implanon. The implant delivery system has a significant market share among contraceptive options, especially in regions with increasing demand for long-acting reversible contraceptives (LARCs).

Market Size and Growth

• Global contraceptive market value (2022): Approximately USD 22 billion.
• Etonogestrel's share: Estimated around 15-20% of LARC segments.
• Projected CAGR (2023–2028): Approx. 6-8%, driven by expanding healthcare access, policy shifts favoring contraception, and rising awareness [1].

Regional Market Distribution

Region	Market Share	Growth Drivers
North America	40%	Strong healthcare infrastructure, high LARC adoption
Europe	25%	Policy incentives, increasing contraceptive awareness
Asia-Pacific	20%	Rising population, healthcare expansion
Rest of World	15%	Emerging markets, expanding reproductive health services

Competitive Environment

Major players manufacturing etonogestrel-based products include:

• Merck & Co. (Nexplanon)
• Bayer AG (Implanon)
• Small pharmaceutical companies with generic offerings

Patent protections for Nexplanon expire around 2030, opening opportunities for generics.

Regulatory and Patent Landscape

• FDA approvals: The etonogestrel implant (Nexplanon) received approval in 2012.
• Patent expiry: Expected in 2030, creating potential for generic competition.
• Regulatory trends: Increasing approvals in emerging markets, though some regions face delays due to regulatory hurdles.

Financial Trajectory

Year	Revenue (USD Billion)	Market Share	Notable Factors
2022	Approx. 1.5	10-15%	Uptake in North America, limited competition
2023	Estimated 1.7-2.0	12-18%	Launch of generic alternatives in 2030
2025+	Growth depends on patent cliffs, new formulations, and regional approvals

Revenue Drivers

• Increased adoption of LARCs in sensitive markets (e.g., youth, postpartum)
• Expansion into developing regions
• Potential generic entrants after patent expiry

Revenue Risks

• Regulatory delays
• Competitive pricing pressures
• Market saturation in mature regions

Future Outlook

• Product innovation: New formulations or delivery mechanisms could extend market lifespan.
• Market expansion: Growing acceptance of contraceptives in Asia and Africa.
• Pricing trends: Generic entry will lower prices, limiting revenue growth but increasing volume.

Key Takeaways

• Etonogestrel's market is primarily driven by contraceptive demand, particularly in LARC segments.
• The global market is projected to grow at 6-8% annually through 2028, with regional variation.
• Patent expiration in 2030 will likely catalyze generic competition, impacting pricing and revenue.
• Market growth relies on expanding access, regulatory approvals, and product innovation.

FAQs

1. How does patent expiry affect etonogestrel's market?
Patent expiry in 2030 is expected to open the market to generic manufacturers, leading to price reductions and increased volume sales.

2. What factors could accelerate the adoption of etonogestrel-based products?
Increased awareness of long-term contraceptive options and supportive healthcare policies in emerging markets.

3. Which regions are the primary markets for etonogestrel products?
North America, Europe, and Asia-Pacific are leading regions with significant market shares.

4. Are there alternative contraceptive options competing with etonogestrel-based products?
Yes, including intrauterine devices (IUDs), oral contraceptives, and barrier methods, but LARCs like etonogestrel implants are preferred for their efficacy.

5. How might product innovation impact etonogestrel's market trajectory?
New formulations or delivery systems could prolong market relevance and create additional revenue streams.

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References

[1] Grand View Research. (2023). Contraceptive Market Size, Share & Trends Analysis Report.