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.

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:	60
Clinical Trials:	29
Patent Applications:	2,087
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

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	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
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	8,888,745		Y

International Patents for NEXPLANON

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

Country	Patent Number	Title	Estimated Expiration
Australia	2007206957
China	1953770	X-ray visible drug delivery device
Denmark	173166
Egypt	24359	x-ray visible drug delivery device
Japan	2009523515
South Korea	950008763
Ukraine	88674	АППЛИКАТОР ДЛЯ ВВЕДЕНИЯ ИМПЛАНТАТА;АПЛІКАТОР ДЛЯ ВВЕДЕННЯ ІМПЛАНТАТА (APPLICATOR FOR INSERTING AN IMPLANT)

Supplementary Protection Certificates for NEXPLANON

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

Market Dynamics and Financial Trajectory for NEXPLANON

Introduction

NEXPLANON, a long-acting, progestin-only single-rod hormonal contraceptive, has been a significant player in the women's health market since its launch in the United States in 2011. Here, we delve into the market dynamics and financial trajectory of NEXPLANON, highlighting key factors influencing its growth and performance.

Market Overview

The subdermal contraceptive implants market, where NEXPLANON is a leading product, is expected to grow substantially. By 2029, this market is projected to reach USD 1.12 billion, growing at a CAGR of 3.97% from 2024[1].

Product Approval and Listings

NEXPLANON has seen significant regulatory approvals and listings, which have bolstered its market presence. For instance, in 2021 and 2022, Organon announced public listings for NEXPLANON in several Canadian provinces, including Ontario, British Columbia, Nova Scotia, and Quebec. These approvals have increased the product's accessibility and demand[1].

Market Drivers

Several factors are driving the growth of NEXPLANON in the market:

Unwanted Pregnancies and Abortion Rates

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 scenario increases the demand for effective contraceptive methods like NEXPLANON[1].

Technological Advancements and Government Support

Technological advancements and supportive government schemes also contribute to the market growth. Governments and health organizations are increasingly promoting long-acting reversible contraceptives (LARCs) like NEXPLANON due to their high efficacy and convenience[1].

Company Strategies

Organon, the company behind NEXPLANON, has implemented various business strategies to enhance market presence. These include product launches, mergers, and strategic pricing adjustments. For example, Organon's decision to reset the timing of list price increases for NEXPLANON has better aligned the company commercially with its customers and healthcare peers[3].

Financial Performance

Revenue Growth

NEXPLANON has been a strong contributor to Organon's revenue. In the fourth quarter of 2023, the Women's Health franchise, which includes NEXPLANON, grew by 8%, and for the full year, it grew by 3%. Organon expects NEXPLANON to deliver $1 billion in revenue in the coming year, driven by strong demand and expanded production capacity[3][5].

Adjusted EBITDA and Net Income

Organon's financial performance has been robust, with an adjusted EBITDA margin of 31% in 2023. The company reported a net income of $1.0 billion for 2023, with adjusted diluted EPS of $4.14. Despite some challenges like higher interest expenses and accelerated amortization of financing costs, the company remains optimistic about its financial outlook[2][3].

Free Cash Flow

Organon generated $940 million in free cash flow before one-time spin-related items in 2023, exceeding previous guidance. The company aims to achieve $1 billion in free cash flow before one-time costs for the full year 2024, indicating strong financial health and potential for future investments[3].

Regional Performance

North America

North America is a key market for NEXPLANON, driven by high demand for effective contraceptives. The region's growth is supported by rising cases of unwanted pregnancies and abortions, as well as technological advancements and government support[1].

International Markets

Outside the U.S., NEXPLANON has seen growth impacted by factors such as public tenders in Mexico and supply constraints in fast-growing markets like Asia and Africa. However, these issues have been largely resolved, and the company expects strong growth in these regions in 2024[3].

Future Prospects

Phase III Study and Exclusivity

Organon anticipates Phase III data from a 5-year study on NEXPLANON by the end of 2024. If approved, this will grant NEXPLANON 3 years of exclusivity on the 5-year efficacy claim in the U.S. market, which is expected to significantly boost its market position due to patient preference for longer-duration contraceptives[3].

Commercial Execution

The company's commercial execution has been strong, with disciplined management of operating costs and proactive pricing strategies. This has helped in maintaining a stable revenue growth trajectory and is expected to continue driving NEXPLANON's success in the future[5].

Challenges and Headwinds

Pricing Pressure and Supply Constraints

NEXPLANON has faced pricing pressure, particularly in the 340B channel, and supply constraints in some international markets. However, Organon has taken steps to manage these challenges, such as adjusting pricing strategies and expanding production capacity[3].

Competitive Landscape

The market for subdermal contraceptive implants is competitive, with other products vying for market share. Organon's strategic focus on NEXPLANON, along with other growth drivers like Emgality and VTAMA, helps in maintaining a competitive edge[5].

Key Takeaways

• Market Growth: The subdermal contraceptive implants market is expected to grow at a CAGR of 3.97% to reach USD 1.12 billion by 2029.
• Regulatory Approvals: NEXPLANON has received significant regulatory approvals and listings, enhancing its market presence.
• Revenue Performance: NEXPLANON is expected to deliver $1 billion in revenue in the coming year, driven by strong demand and expanded production capacity.
• Financial Health: Organon has reported robust financial performance with a strong adjusted EBITDA margin and free cash flow.
• Future Prospects: The anticipated Phase III study data and potential exclusivity on the 5-year efficacy claim are expected to boost NEXPLANON's market position.

FAQs

What is NEXPLANON and how does it work?

NEXPLANON is a long-acting, progestin-only single-rod hormonal contraceptive that prevents pregnancy for up to three years by releasing etonogestrel, a synthetic form of the hormone progestin[4].

How has NEXPLANON performed financially in recent years?

NEXPLANON has been a strong contributor to Organon's revenue, with the Women's Health franchise growing by 8% in the fourth quarter of 2023 and 3% for the full year. The company expects NEXPLANON to deliver $1 billion in revenue in the coming year[3][5].

What are the key drivers of NEXPLANON's market growth?

Key drivers include high rates of unwanted pregnancies and abortions, technological advancements, and supportive government schemes. Additionally, Organon's strategic business strategies and regulatory approvals have played a crucial role[1][3].

What challenges has NEXPLANON faced in the market?

NEXPLANON has faced pricing pressure, particularly in the 340B channel, and supply constraints in some international markets. However, the company has taken steps to manage these challenges[3].

What are the future prospects for NEXPLANON?

Organon anticipates Phase III data from a 5-year study on NEXPLANON by the end of 2024, which could grant it 3 years of exclusivity on the 5-year efficacy claim in the U.S. market. This, along with strong commercial execution and expanded production capacity, positions NEXPLANON for continued growth[3].

Sources

1. Mordor Intelligence: Subdermal Contraceptive Implants Market Size.
2. Organon: Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2023.
3. Organon & Co.: Transcript-Organon Co-Q4 2023 Earnings Call-Feb 15, 2024.
4. Merck: Merck Launches NEXPLANON® (etonogestrel implant) 68 mg in the United States.
5. Organon: Organon Reports Results for the Third Quarter Ended September 30, 2024.