ETHINYL ESTRADIOL; ETONOGESTREL - Generic Drug Details

What are the generic drug sources for ethinyl estradiol; etonogestrel and what is the scope of freedom to operate?

Ethinyl estradiol; etonogestrel is the generic ingredient in six branded drugs marketed by Amneal, Xiromed, Teva Pharms Usa Inc, Dr Reddys Labs Sa, and Organon Usa Organon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for ETHINYL ESTRADIOL; ETONOGESTREL

US Patents:	0
Tradenames:	6
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	10
Clinical Trials:	12
DailyMed Link:	ETHINYL ESTRADIOL; ETONOGESTREL at DailyMed

Recent Clinical Trials for ETHINYL ESTRADIOL; ETONOGESTREL

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

Sponsor	Phase
Lupin Research Inc	Phase 2
Wits Reproductive Health and HIV Institute	Phase 1
Merck Sharp & Dohme LLC	Phase 1

See all ETHINYL ESTRADIOL; ETONOGESTREL clinical trials

Pharmacology for ETHINYL ESTRADIOL; ETONOGESTREL

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; 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

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; ETONOGESTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUVARING	Vaginal Ring	ethinyl estradiol; etonogestrel	0.015 mg/24 hour 0.12 mg/24 hour	021187	1	2013-06-17

US Patents and Regulatory Information for ETHINYL ESTRADIOL; ETONOGESTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	VERARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	207577-001	Dec 9, 2021		DISCN	No	No
Xiromed	ENILLORING	ethinyl estradiol; etonogestrel	RING;VAGINAL	211157-001	Jun 29, 2023	AB	RX	No	No
Teva Pharms Usa Inc	ETHINYL ESTRADIOL; ETONOGESTREL	ethinyl estradiol; etonogestrel	RING;VAGINAL	204305-001	Jan 13, 2021	AB	RX	No	No

Expired US Patents for ETHINYL ESTRADIOL; ETONOGESTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	NUVARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	021187-001	Oct 3, 2001	5,989,581

ETHINYL ESTRADIOL; ETONOGESTREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Etonogestrel and Ethinyl Estradiol

Introduction

The market for etonogestrel and ethinyl estradiol, key components of contraceptive products like the NuvaRing, is experiencing significant growth and transformation. This article delves into the market dynamics, financial trajectory, and key factors influencing the demand and supply of these drugs.

Market Size and Growth Projections

The etonogestrel market is anticipated to undergo robust growth from 2023 to 2031. According to recent market research, the optimistic trajectory in market dynamics suggests that this expansion will be sustained over the forecast period. The market size is expected to increase substantially, driven by various factors such as increasing demand for contraceptive methods and advancements in healthcare technologies[1].

Segmentation of the Market

The etonogestrel market is segmented based on type, application, and geographical regions. The types include Etonogestrel/Ethinyl estradiol (ENG/EE) Contraceptive Rings, Estradiol Contraceptive Rings, Progesterone Contraceptives Rings, and Segesterone acetate/Ethinyl estradiol (SA/EE) Contraceptive Rings, among others. Applications are categorized into Retail Pharmacies, Hospital Pharmacies, Clinics, and others. Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Key Drivers of Market Growth

Several factors are driving the growth of the etonogestrel market:

• Increasing Demand for Contraceptives: The global need for effective and convenient contraceptive methods is on the rise, particularly among younger demographics.
• Advancements in Healthcare Technology: Innovations such as 3D-printed intravaginal rings (IVRs) are enhancing the delivery and efficacy of these drugs[3].
• Expanding Product Portfolio: Companies like Teva are launching generic versions of popular products like NuvaRing, increasing accessibility and affordability[4].

Financial Performance

The financial performance of etonogestrel and ethinyl estradiol products is robust. For instance, the annual sales of etonogestrel and ethinyl estradiol vaginal ring products in the U.S. exceed $837 million, as per data from IQVIA as of November 2020[4].

Competitive Landscape

The market is competitive, with key players such as QPharma AB, Merck, Pfizer, Laboratorios Andromaco, Janssen Pharmaceutical, and Allergan. These companies are investing in research and development to improve product efficacy and safety. For example, Merck has stood behind the safety profile of NuvaRing, emphasizing its efficacy and the importance of patient-provider discussions about benefits and risks[5].

Pharmacokinetics and Efficacy

The pharmacokinetics of etonogestrel and ethinyl estradiol, particularly from products like NuvaRing, have been extensively studied. Maximum serum concentrations of these hormones are achieved approximately one week after insertion, with a gradual decrease thereafter. The bioavailability of etonogestrel from NuvaRing is higher compared to combined oral contraceptives (COCs), while the systemic exposure to ethinyl estradiol is lower[2].

Safety Profile

The safety profile of etonogestrel and ethinyl estradiol products is a critical consideration. These drugs are associated with increased risks of serious side effects such as blood clots, stroke, or heart attack, especially in women with other risk factors. Merck and other manufacturers emphasize the importance of monitoring and discussing these risks with healthcare providers[5].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics. Products like NuvaRing have undergone rigorous clinical trials and have been approved by regulatory agencies such as the FDA. Companies must comply with strict guidelines and continuously monitor the safety of their products to maintain regulatory approval[5].

Consumer Behavior and Preferences

Consumer behavior is shifting towards more convenient and effective contraceptive methods. The preference for non-oral contraceptives, such as vaginal rings, is increasing due to their ease of use and lower risk of user error compared to daily pills.

Economic, Political, and Social Factors

Economic factors, such as the cost of healthcare and insurance coverage, influence the market. Political and social factors, including reproductive health policies and societal attitudes towards contraception, also impact demand and accessibility.

Technological Innovations

Technological innovations, such as 3D printing, are revolutionizing the production and delivery of etonogestrel and ethinyl estradiol. These advancements could lead to more personalized and effective contraceptive solutions in the future[3].

Challenges and Opportunities

Despite the growth, the market faces challenges such as regulatory hurdles, competition from other contraceptive methods, and the need for continuous safety monitoring. However, opportunities abound in emerging markets and through the development of new, innovative products.

Key Players and Market Strategies

Key players are adopting various strategies to maintain market share and drive growth. These include expanding product portfolios, investing in research and development, and enhancing distribution channels. For example, Teva's launch of a generic version of NuvaRing has expanded accessibility and reduced costs for consumers[4].

Geographical Analysis

The market is geographically diverse, with North America and Europe being significant contributors due to high demand and advanced healthcare infrastructure. The Asia-Pacific region is also expected to grow rapidly due to increasing awareness and demand for contraceptive methods[1].

Future Outlook

The future outlook for the etonogestrel and ethinyl estradiol market is promising. With continued advancements in technology, increasing demand, and strategic market initiatives by key players, the market is poised for sustained growth.

Key Takeaways

• The etonogestrel market is expected to experience robust growth from 2023 to 2031.
• Key drivers include increasing demand for contraceptives, technological advancements, and expanding product portfolios.
• The financial performance of these products is strong, with annual sales exceeding $837 million in the U.S.
• The market is competitive, with key players focusing on research, development, and safety monitoring.
• Regulatory compliance and continuous safety monitoring are crucial.
• Technological innovations and geographical expansion offer significant opportunities for growth.

FAQs

Q: What are the main types of etonogestrel products in the market? A: The main types include Etonogestrel/Ethinyl estradiol (ENG/EE) Contraceptive Rings, Estradiol Contraceptive Rings, Progesterone Contraceptives Rings, and Segesterone acetate/Ethinyl estradiol (SA/EE) Contraceptive Rings[1].

Q: How do the pharmacokinetics of etonogestrel and ethinyl estradiol from NuvaRing compare to combined oral contraceptives? A: The bioavailability of etonogestrel from NuvaRing is higher, while the systemic exposure to ethinyl estradiol is lower compared to combined oral contraceptives[2].

Q: What are the significant risks associated with etonogestrel and ethinyl estradiol products? A: These products are associated with increased risks of blood clots, stroke, or heart attack, especially in women with other risk factors[5].

Q: Which companies are key players in the etonogestrel market? A: Key players include QPharma AB, Merck, Pfizer, Laboratorios Andromaco, Janssen Pharmaceutical, and Allergan[1].

Q: What is the impact of technological innovations on the etonogestrel market? A: Technological innovations, such as 3D printing, are enhancing the production and delivery of etonogestrel and ethinyl estradiol, leading to more personalized and effective contraceptive solutions[3].

Sources

1. Market Research Intellect: Etonogestrel Market Size, Scope And Forecast Report.
2. PubMed: Pharmacokinetics of etonogestrel and ethinylestradiol released from a novel combined contraceptive vaginal ring (NuvaRing).
3. PubMed: Next-Generation Contraceptive Intravaginal Ring.
4. Teva Pharmaceuticals: Teva Announces Launch of a Generic Version of NuvaRing.
5. Merck: Merck Stands Behind the Safety Profile of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring).