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:	75
Patent Applications:	3,462
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
Bill and Melinda Gates Foundation	Phase 4
Lori Gawron	Phase 4
Planned Parenthood Association of Utah	Phase 4

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

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	8,888,745		Y
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	8,722,037		Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	10,821,277		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
Russian Federation	2361627	АППЛИКАТОР ДЛЯ ВВЕДЕНИЯ ИМПЛАНТАТА (APPLICATOR FOR IMPLANT INTRODUCTION)
Norway	20073748
Norway	338191
Mexico	2007008881	APLICADOR PARA INSERTAR UN IMPLANTE. (APPLICATOR FOR INSERTING AN IMPLANT.)

Supplementary Protection Certificates for etonogestrel

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

Etonogestrel Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Etonogestrel

Introduction to Etonogestrel

Etonogestrel, a synthetic progestin, is a key component in several contraceptive methods, most notably the subdermal contraceptive implant. This implant, known by the brand name Nexplanon, has been gaining significant traction in the global market due to its efficacy, convenience, and additional health benefits.

Market Segmentation and Dominance

The global subdermal contraceptive implants market is segmented into etonogestrel implants, levonorgestrel implants, and others. The etonogestrel implant segment has consistently held the largest share of this market. In 2018, it dominated the global subdermal contraceptive implants market, and this trend is expected to continue during the forecast period[1][4].

Reasons for Dominance

Several factors contribute to the dominance of etonogestrel implants:

• Safety During Breastfeeding: Etonogestrel implants are safe for use during breastfeeding, making them a preferred choice for new mothers.
• Symptom Relief: These implants improve symptoms of dysmenorrhea and endometriosis, adding to their appeal.
• Convenience: The long-acting reversible nature of these implants makes them a convenient option for women seeking effective contraception without the daily or weekly maintenance required by other methods[1].

Financial Performance and Revenue Growth

Organon's Role

Organon, a company spun off from Merck & Co., Inc. in June 2021, has been a significant player in the women's health sector, particularly with its Nexplanon brand. In the second quarter of 2023, Organon reported an 8% increase in women's health revenue on an as-reported basis and a 10% increase excluding the impact of foreign currency, driven primarily by a 12% increase in Nexplanon sales[2].

Revenue Figures

• Total Revenue: Organon's total revenue for the second quarter of 2023 was $1,608 million, a 1% increase from the same period in 2022.
• Women's Health Segment: The women's health segment, which includes Nexplanon, saw significant growth, contributing to the overall revenue increase[2].

Market Growth Projections

Global Market Size

The global subdermal contraceptive implants market is expected to reach USD 0.92 billion in 2024 and grow at a compound annual growth rate (CAGR) of 3.97% to reach USD 1.12 billion by 2029[4].

Regional Growth

• North America: This region is anticipated to witness considerable growth due to rising cases of unwanted pregnancies, high abortion rates, technological advancements, and supportive government schemes. For instance, between 2020 and 2022, there were over 5.6 million pregnancies in North America, with 2.59 million being unwanted and 886,000 resulting in abortion[4].

Business Strategies and Market Expansion

Product Listings and Approvals

Organon has been actively expanding the availability of Nexplanon through public listings in various regions. For example, in November 2021, Nexplanon was listed under the Régie de l'assurance Maladie du Québec (RAMQ) in Quebec, and in January 2022, it was listed in Ontario, British Columbia, and Nova Scotia. These approvals and listings are expected to boost market growth[4].

Mergers and Spin-Offs

The spin-off of Organon from Merck & Co., Inc. in June 2021 has allowed the company to focus more intensely on women's health products, including contraceptive and fertility brands. This strategic move is likely to enhance the market presence and growth of etonogestrel implants[4].

Cost-Effectiveness and Pharmacoeconomic Analysis

Cost Savings

Studies have shown that etonogestrel-releasing subdermal contraceptive implants can be highly cost-effective. For instance, a pharmacoeconomic analysis in Brazil indicated that adopting these implants could result in significant cost avoidance compared to levonorgestrel-releasing intrauterine systems (LNG-IUSs). The estimated cost avoidance was $7.64 million in the first year and $82.45 million over five years[5].

User Satisfaction and Tolerability

The etonogestrel implant has been well-received by users due to its high efficiency, tolerability, and satisfaction rates. Nearly 40% of participants in one study preferred to continue using only the implant and stop combined hormonal contraceptives (CHCs)[5].

Key Challenges and Opportunities

Generic Competition

Despite the growth, the market faces challenges such as generic competition. For example, NuvaRing, another product from Organon, has seen a 3% decline due to generic competition[2].

Technological Advancements

Technological advancements and supportive government schemes are expected to drive the market forward. The increasing focus on women's health and reproductive rights is likely to expand the market for etonogestrel implants.

Conclusion

The etonogestrel implant market is poised for significant growth driven by its safety, convenience, and cost-effectiveness. With ongoing product listings, approvals, and strategic business moves, the market is expected to expand, particularly in regions like North America.

Key Takeaways

• Market Dominance: Etonogestrel implants dominate the subdermal contraceptive implants market.
• Financial Growth: Organon's revenue has seen significant increases due to the success of Nexplanon.
• Cost-Effectiveness: Etonogestrel implants offer substantial cost savings compared to other contraceptive methods.
• Regional Growth: North America is expected to see considerable growth due to rising cases of unwanted pregnancies and supportive government schemes.
• User Satisfaction: High user satisfaction rates contribute to the market's growth.

FAQs

1. What is the primary segment dominating the subdermal contraceptive implants market?

   • The etonogestrel implant segment dominates the global subdermal contraceptive implants market.

2. Which company is a major player in the etonogestrel implant market?

   • Organon, spun off from Merck & Co., Inc., is a significant player in the market with its Nexplanon brand.

3. What are the key factors driving the growth of the etonogestrel implant market?

   • Factors include safety during breastfeeding, symptom relief for dysmenorrhea and endometriosis, convenience, and cost-effectiveness.

4. How does the etonogestrel implant compare to other contraceptive methods in terms of cost?

   • The etonogestrel implant is highly cost-effective, offering significant cost savings compared to levonorgestrel-releasing intrauterine systems (LNG-IUSs).

5. What are the regional growth prospects for the etonogestrel implant market?

   • North America is expected to witness considerable growth due to rising cases of unwanted pregnancies and supportive government schemes.

Sources

1. BioSpace - Subdermal Contraceptive Implants Market: Etonogestrel Implant to Witness Significant Demand
2. Organon - Reports Results for the Second Quarter Ended June 30, 2023
3. Cognitivemarketresearch.com - Etonogestrel Market Report 2024 (Global Edition)
4. Mordor Intelligence - Subdermal Contraceptive Implants Market Size
5. PLOS ONE - Etonogestrel-releasing subdermal contraceptive implant