ETHINYL ESTRADIOL; NORELGESTROMIN - Generic Drug Details

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

Ethinyl estradiol; norelgestromin is the generic ingredient in four branded drugs marketed by Amneal, Zydus Pharms, Teva Pharms Usa, Janssen Pharms, and Mylan Technologies, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for ETHINYL ESTRADIOL; NORELGESTROMIN

US Patents:	0
Tradenames:	4
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	8
Clinical Trials:	21
DailyMed Link:	ETHINYL ESTRADIOL; NORELGESTROMIN at DailyMed

Recent Clinical Trials for ETHINYL ESTRADIOL; NORELGESTROMIN

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

Sponsor	Phase
Chulalongkorn University	PHASE2
Mylan Technologies Inc.	Phase 3
Mylan Inc.	Phase 3

See all ETHINYL ESTRADIOL; NORELGESTROMIN clinical trials

Pharmacology for ETHINYL ESTRADIOL; NORELGESTROMIN

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; NORELGESTROMIN

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; NORELGESTROMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORTHO EVRA	Transdermal System	ethinyl estradiol; norelgestromin	0.15 mg/0.02 mg per 24 hours	021180	1	2007-03-22

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORELGESTROMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ETHINYL ESTRADIOL AND NORELGESTROMIN	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	213950-001	Feb 25, 2021	AB	RX	No	No
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001		DISCN	Yes	No
Teva Pharms Usa	ONSURA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	213977-001	Aug 25, 2021	AB	RX	No	No
Mylan Technologies	XULANE	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	200910-001	Apr 16, 2014	AB	RX	No	Yes
Zydus Pharms	ETHINYL ESTRADIOL AND NORELGESTROMIN	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	214594-001	Sep 14, 2023	AB	RX	No	No

Expired US Patents for ETHINYL ESTRADIOL; NORELGESTROMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001

EU/EMA Drug Approvals for ETHINYL ESTRADIOL; NORELGESTROMIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gedeon Richter Plc.	Evra	norelgestromin, ethinyl estradiol	EMEA/H/C/000410Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.	Authorised	no	no	no	2002-08-22

Market Dynamics and Financial Trajectory for Ethinyl Estradiol and Norelgestromin

Last updated: July 29, 2025

Introduction

Ethinyl Estradiol (EE) combined with Norelgestromin represents a well-established formulation within the oral contraceptive landscape. This hormonal combination has been a mainstay in reproductive health for decades, owing to its proven efficacy, safety profile, and widespread acceptance. However, recent shifts in market dynamics, regulatory frameworks, technological innovations, and consumer preferences are shaping its current and future financial trajectory. This analysis evaluates the key market forces influencing this pharmaceutical segment and projects future growth patterns.

Market Overview

Ethinyl Estradiol (EE) is a synthetic estrogen frequently paired with a synthetic progestin, Norelgestromin, to prevent pregnancy. The combination has dominated the global oral contraceptive market, accounting for a significant share due to its high efficacy, ease of use, and favorable side-effect profile relative to older preparations. According to Transparency Market Research, the global contraceptive market expanded at a compound annual growth rate (CAGR) of approximately 4.8% between 2015 and 2020, with oral contraceptives comprising over 60% of the segment's sales [1].

Despite being a mature product, the combined EE-Norelgestromin formulations continue to generate robust revenues, especially in regions with high contraceptive acceptance rates, including North America, Europe, and parts of Asia-Pacific. Emerging markets present substantial untapped potential, driven by rising awareness, expanding healthcare infrastructure, and increasing female workforce participation.

Market Drivers and Influencers

1. Efficacy and Safety Perception
   The prolonged use of EE/Norelgestromin formulations has solidified their reputation for reliability and ease of use. Continued clinical validation and favorable risk-benefit profiles maintain consumer trust. Regulatory approvals concerning safety profiles further reinforce market stability.

2. Regulatory Environment
   Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), maintain stringent standards for hormonal contraceptives. While these regulations provide safety assurance, they also impose barriers for new entrants. Existing formulations benefit from patent expirations and streamlined approval pathways, enabling generic proliferation and price competition.

3. Generic Competition
   The expiration of key patents has catalyzed a surge in generic versions, leading to significant price erosion. Cost competitiveness enhances access, especially in price-sensitive markets, but also compresses profit margins for originators.

4. Advances in Formulation Technology
   Innovations in delivery mechanisms—such as transdermal patches, vaginal rings, and subdermal implants—are gradually diversifying contraceptive options. While oral EE/Norelgestromin remains dominant, these alternatives influence market share dynamics.

5. Socioeconomic and Cultural Factors
   Changing societal attitudes towards contraception, increased awareness, and supportive policies bolster demand. Conversely, cultural and religious barriers in certain regions may impede market growth.

6. Emerging Markets
   Rapidly expanding healthcare infrastructure, government initiatives promoting family planning, and rising female literacy accelerate market penetration in Asia-Pacific, Latin America, and Africa.

Challenges and Market Risks

• Side Effects and Safety Concerns
  Potential risks such as thromboembolic events associated with high-dose EE formulations lead to regulatory restrictions and consumer hesitance. These concerns drive innovation for lower-dose combinations or alternative hormonal regimens.

• Availability of Alternative Contraception
  The growing acceptance of long-acting reversible contraceptives (LARCs) like intrauterine devices (IUDs) and implants offers substitutes to oral pills, potentially dampening demand.

• Regulatory and Legal Risks
  Revisions in prescribing guidelines and increased litigation risks, particularly related to adverse events, can impact sales trajectories and cost structures.

Financial Trajectory Analysis

Historical Performance and Current Trends

Historically, the EE/Norelgestromin market has demonstrated steady growth aligned with global population expansion and contraceptive acceptance. Market size was valued at approximately USD 5.5 billion in 2022 and is projected to reach USD 7.2 billion by 2027, expanding at a CAGR of around 5%, driven predominantly by generic drug sales and increasing access in emerging markets [2].

Impact of Patent Expirations

Patent expirations for major formulations, such as Loestrin and Ortho Tri-Cyclen, have driven generic entry, decreasing prices by up to 50% in some markets. While this amplifies volume sales, gross margins for originator companies have contracted. Innovative formulations and combination pills with alternative hormonal ratios attempt to offset revenue declines.

Emerging Opportunities

• Low-Dose and Extended-Cycle Formulations: Demand for reduced estrogen exposure and extended cycle pills is growing, driven by consumer preference for convenience and safety. Companies investing in these formulations are poised for moderate growth.

• Non-Oral Delivery Systems: Patches and vaginal rings incorporating EE and synthetic progestins are gaining regulatory approval, signaling a shift towards diversified delivery methods. These alternatives are projected to capture up to 10% of the contraception market by 2030.

• Biosimilars and Generic Platforms: Streamlined manufacturing and regulatory pathways for biosimilars and generics could further intensify market competition, driving down prices but expanding access.

Forecast and Future Outlook

Given current trajectories, the EE/Norelgestromin contraceptive segment is expected to maintain moderate growth but with evolving competition landscapes. The CAGR is projected at around 4-6% over the next five years, with significant contributions from emerging markets and technological innovations. Key influencing factors include:

• Pricing and reimbursement policies in developed markets will influence volume and profit margins.
• Regulatory shifts toward safety profiles favoring lower-dose formulations will shape R&D priorities.
• Consumer shifting preferences towards non-invasive and long-acting options may limit future growth potential for traditional oral formulations unless companies adapt.

Regulatory and Market Access Considerations

Regulatory agencies' increased focus on cardiovascular risks has prompted dosage adjustments, labeling updates, and post-market surveillance intensification. Furthermore, global health initiatives, such as the World Health Organization’s Family Planning program, continue to facilitate market access and funding, benefiting product sales in developing countries.

Conclusion

The financial trajectory of Ethinyl Estradiol combined with Norelgestromin is characterized by market maturation, intensified generic competition, and advancing alternative delivery systems. While growth may moderate compared to past decades, strategic innovation, expansion into underserved markets, and formulation diversification can sustain revenue streams. Stakeholders must navigate regulatory complexities and evolving consumer preferences to optimize profitability.

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Key Takeaways

• The EE/Norelgestromin contraceptive market remains substantial, with projections indicating steady growth in key regions despite challenges.
• Patent expirations have driven a surge in generics, compressing profit margins but increasing market penetration.
• Innovations in delivery systems and dosage forms are strategic opportunities for differentiation and growth.
• Regulatory concerns about safety drive industry shifts toward lower-dose and alternative hormonal combinations.
• Expanding access in emerging markets provides significant revenue potential for pharmaceutical companies.

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FAQs

1. How will patent expirations affect the profitability of EE/Norelgestromin contraceptives?
Patent expirations lead to increased generic competition, which reduces drug prices and profit margins for brand-name products. However, they also expand market volume, especially in price-sensitive regions, potentially offsetting margin declines through higher sales volumes.

2. What emerging formulations threaten the dominance of traditional oral EE/Norelgestromin pills?
Non-oral delivery systems like transdermal patches, vaginal rings, and subdermal implants incorporating EE or alternative hormones are gaining prominence. Extended-cycle and lower-dose pills also offer consumer-preferred options.

3. How do safety concerns influence the future development of EE-based contraceptives?
Regulatory focus on thromboembolism risks prompts development of lower-dose formulations and alternative hormonal combinations, which may result in a shift away from high-dose EE formulations.

4. Which markets are expected to drive the most growth in the EE/Norelgestromin segment?
Emerging economies in Asia-Pacific, Latin America, and Africa present the most significant growth opportunities due to increasing awareness, improving healthcare infrastructure, and supportive policies.

5. What strategic steps should companies consider to maintain competitiveness in this market?
Invest in formulation innovation, diversify delivery methods, explore lower-dose options, expand into underserved geographies, and ensure compliance with evolving safety standards to sustain growth and market share.

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References

[1] Transparency Market Research, “Contraceptive Market Outlook,” 2021.
[2] MarketWatch, “Global Contraceptive Market Size & Share,” 2022.