IMPLANON Drug Patent Profile

When do Implanon patents expire, and what generic alternatives are available?

Implanon is a drug marketed by Organon and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-three patent family members in twenty-seven countries.

The generic ingredient in IMPLANON 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 Implanon

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 28, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IMPLANON

International Patents:	33
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	25
Patent Applications:	2,087
DailyMed Link:	IMPLANON at DailyMed

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

Constraining patent/regulatory exclusivity:

8,722,037

NDA:

021529

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 IMPLANON

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

Sponsor	Phase
United States Agency for International Development (USAID)	Phase 4
Kenya Medical Research Institute	Phase 4
Eastern Virginia Medical School	Phase 4

See all IMPLANON clinical trials

Pharmacology for IMPLANON

Drug Class

Progestin

US Patents and Regulatory Information for IMPLANON

IMPLANON is protected by one US patents.

This potential generic entry date is based on patent 8,722,037.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for IMPLANON

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 IMPLANON

When does loss-of-exclusivity occur for IMPLANON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Egypt

Latvia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering IMPLANON around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20061225	APLICADOR PARA INSERTAR UN IMPLANTE
Spain	2308460
Mexico	PA06010714	DISPOSITIVO DE SUMINISTRO DE FARMACOS VISIBLE A TRAVES DE RAYOS-X. (X-RAY VISIBLE DRUG DELIVERY DEVICE.)
South Africa	8805034
European Patent Office	1841492	APPAREIL DE POSE D'IMPLANT (APPLICATOR FOR INSERTING AN IMPLANT)
Portugal	88220	PROCESSO DE PREPARACAO DE UM IMPLANTE COM ACCAO CONTRACEPTIVA

Supplementary Protection Certificates for IMPLANON

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

IMPLANON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IMPLANON

Introduction to IMPLANON

IMPLANON, also known as NEXPLANON in some regions, is a subdermal contraceptive implant that has been a cornerstone in family planning for nearly three decades. This implant, which releases etonogestrel, is one of the most effective forms of contraception available, with a failure rate of less than 1% when used correctly.

Market Size and Growth

The subdermal contraceptive implants market, which includes IMPLANON, is projected to experience significant growth over the coming years. By 2029, the market is expected to reach USD 1.12 billion, growing at a Compound Annual Growth Rate (CAGR) of 3.97% from its 2024 value of USD 0.92 billion[1][4].

Key Drivers of Market Growth

Increasing Approvals and Product Listings

The market growth for IMPLANON is driven by increasing approvals and public listings in various regions. For instance, Organon announced public listings for NEXPLANON in Ontario, British Columbia, Nova Scotia, and Quebec, which has expanded its accessibility and contributed to market growth[1][4].

Rising Cases of Unwanted Pregnancies

High rates of unwanted pregnancies and abortions, particularly in North America, are significant drivers. According to the Guttmacher Institute, between 2020 and 2022, there were over 5.6 million pregnancies annually in North America, with 2.59 million being unwanted and 886,000 resulting in abortion. This trend is expected to increase demand for effective contraceptive methods like IMPLANON[1][4].

Technological Advancements and Government Support

Technological advancements and supportive government schemes also play a crucial role. The North American region, with its strong healthcare infrastructure and government support, is expected to witness considerable growth in the adoption of subdermal contraceptive implants[1][4].

Financial Performance of Key Players

Organon's Financial Trajectory

Organon, the company behind NEXPLANON, has shown robust financial performance. In 2023, Organon reported a total revenue of $6.3 billion, an increase of 1% on an as-reported basis and 3% at constant currency compared to 2022. The company's Adjusted EBITDA margin was 31.0% for the full year 2023, although it saw a year-over-year decrease due to higher cost of sales and other factors[2].

For the fourth quarter of 2023, Organon's total revenue was $1.598 billion, an 8% increase from the same period in 2022. The company's net income for 2023 was $1.0 billion, or $3.99 per diluted share, reflecting a mix of positive and negative factors such as higher interest expenses and favorable tax benefits[2].

Revenue Projections

Given the increasing demand and expanding market, Organon's revenue from NEXPLANON is expected to contribute significantly to the company's overall financial performance. The company has provided a full-year 2024 revenue guidance range of $6.2 billion to $6.5 billion, with an Adjusted EBITDA margin expected to be between 31.0% and 33.0%[2].

Regional Market Dynamics

North America

North America is a key region for the growth of the subdermal contraceptive implants market. The region's strong healthcare infrastructure, high awareness of reproductive health, and large consumer base make it an ideal market for products like IMPLANON. The U.S. and Canada are expected to drive significant demand due to their well-established regulatory frameworks and supportive government policies[1][3][4].

Global Expansion

While North America dominates the market, other regions are also seeing increased adoption of subdermal contraceptive implants. Efforts to enhance access and affordability, such as the Implanon Access Initiative, have improved the availability of these implants in developing countries, further contributing to global market growth[5].

Challenges and Opportunities

Side Effects and Access Disparities

Despite the growth, the market faces challenges such as concerns over side effects and access disparities. Hormonal contraceptives, including IMPLANON, can have side effects like weight changes, mood swings, and rare cases of blood clots. Addressing these concerns through improved product formulations and enhanced patient education will be crucial[3].

Regulatory Scrutiny

Regulatory bodies are increasingly scrutinizing the safety and efficacy of hormonal contraceptives, which may impact market dynamics. Ensuring compliance with regulatory standards and maintaining consumer trust will be essential for continued market growth[3].

Innovation in Delivery Methods

The future of the market is likely to see innovation in delivery methods, reduced side effects, and a focus on personalized medicine. Companies are expected to invest in research and development to cater to diverse patient needs, which could further boost the adoption of subdermal contraceptive implants[3].

Key Takeaways

• The subdermal contraceptive implants market, including IMPLANON, is projected to grow significantly, reaching USD 1.12 billion by 2029.
• Increasing approvals, public listings, and rising cases of unwanted pregnancies are key drivers of market growth.
• Organon's financial performance indicates strong revenue and profitability, with NEXPLANON contributing significantly to these figures.
• North America is expected to dominate the market due to its strong healthcare infrastructure and supportive government policies.
• Addressing side effects, access disparities, and regulatory scrutiny will be crucial for sustained market growth.

FAQs

What is IMPLANON?

IMPLANON, also known as NEXPLANON in some regions, is a subdermal contraceptive implant that releases etonogestrel to prevent pregnancy.

How effective is IMPLANON?

IMPLANON is one of the most effective forms of contraception, with a failure rate of less than 1% when used correctly.

What are the key drivers of the IMPLANON market?

Key drivers include increasing approvals and public listings, rising cases of unwanted pregnancies, technological advancements, and supportive government schemes.

Which region is expected to dominate the IMPLANON market?

North America is expected to dominate the market due to its strong healthcare infrastructure, high awareness of reproductive health, and large consumer base.

What challenges does the IMPLANON market face?

The market faces challenges such as concerns over side effects, access disparities, and regulatory scrutiny.

How is Organon's financial performance related to IMPLANON?

Organon's revenue and profitability are significantly influenced by the sales of NEXPLANON, with the company reporting robust financial performance in recent years.

Sources

1. Mordor Intelligence: Subdermal Contraceptive Implants Market Size | Mordor Intelligence
2. Organon: Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2023
3. GlobeNewswire: Hormonal Contraceptive Market Projected to Reach 26.7 Billion by 2032
4. Mordor Intelligence: Subdermal Contraceptive Implants Market Trends
5. PATH: Contraceptive Implants - PATH