Ethinyl estradiol; levonorgestrel - Generic Drug Details

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

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-five branded drugs marketed by Agile, Glenmark Pharms Ltd, Avion Pharms, Lupin Ltd, Novast Labs, Aurobindo Pharma Ltd, Xiromed, Naari Pte, Watson Labs, Dr Reddys Labs Sa, Aurobindo Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Sun Pharm, Exeltis Usa Inc, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, Amneal Pharms, Hetero Labs, and Ph Health, and is included in seventy-six NDAs. There are seven patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; levonorgestrel has sixty-seven patent family members in twenty countries.

Twenty-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ethinyl estradiol; levonorgestrel

International Patents:	67
US Patents:	7
Tradenames:	55
Applicants:	24
NDAs:	76
Finished Product Suppliers / Packagers:	23
Clinical Trials:	71
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; levonorgestrel
DailyMed Link:	ethinyl estradiol; levonorgestrel at DailyMed

Recent Clinical Trials for ethinyl estradiol; levonorgestrel

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

Sponsor	Phase
Pfizer	PHASE1
Vertex Pharmaceuticals Incorporated	PHASE1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE2

See all ethinyl estradiol; levonorgestrel clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant	Application No.	Strength	Dosage Form
		0.03MG,0.01MG; 0.15MG,N/A	TABLET;ORAL
		0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ethinyl estradiol; levonorgestrel

Drug Class	Estrogen Progestin Progestin-containing Intrauterine System
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; levonorgestrel

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03AD	Emergency contraceptives
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; LEVONORGESTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14
QUARTETTE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg	204061	1	2013-07-10
LOSEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg and 0.01 mg	022262	1	2009-11-16
SEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg/0.01 mg	021840	1	2008-01-22
LYBREL	Tablets	ethinyl estradiol; levonorgestrel	0.09 mg/0.02 mg	021864	1	2007-10-05
SEASONALE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg	021544	1	2004-03-29

US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel

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	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	078834-001	May 31, 2011	AB	RX	No	No
Dr Reddys Labs Sa	TRIVORA-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	074538-002	Dec 18, 1997	AB	RX	No	Yes
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003	AB	RX	Yes	Yes
Dr Reddys Labs Sa	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	077681-001	May 31, 2006	AB2	RX	No	Yes

Expired US Patents for ethinyl estradiol; levonorgestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LYBREL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021864-001	May 22, 2007
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008
Teva Branded Pharm	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061-001	Mar 28, 2013
Teva Branded Pharm	NORDETTE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982

International Patents for ethinyl estradiol; levonorgestrel

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1648382	PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES POSOLOGIES CONTRACEPTIVES AVEC ADMINISTRATION CONTINUE D'OESTROGENES (METHODS OF HORMONAL TREATMENT UTILIZING CONTRACEPTIVE REGIMENS WITH CONTINUOUS ESTROGEN ADMINISTRATION)
Russian Federation	2009120528
Hong Kong	1142798	具有原位密封的皮膚遞送裝置 (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)
World Intellectual Property Organization (WIPO)	2009009651

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129

Market Dynamics and Financial Trajectory for Ethinyl Estradiol; Levonorgestrel

Last updated: July 27, 2025

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Introduction

Ethinyl estradiol combined with levonorgestrel remains a cornerstone in contraceptive therapy. As a widely prescribed hormonal combination, its market dynamics are influenced by evolving regulatory landscapes, technological advancements, consumer preferences, and competitive forces. This report explores the current market environment, key drivers, challenges, and future financial trajectories of this pharmaceutical combination.

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Market Overview

The global market for combined oral contraceptives (COCs), predominantly comprising ethinyl estradiol and levonorgestrel, was valued at approximately USD 3.7 billion in 2022, with projections estimating a compound annual growth rate (CAGR) of 4% over the next five years [1]. This growth underscores an enduring demand driven by demographic trends, increasing awareness, and expanding access to family planning.

Regionally, North America dominates the market, benefitting from high contraceptive usage, robust healthcare infrastructure, and active marketing campaigns. Europe follows, with significant market share attributed to progressive reproductive health policies. Asia-Pacific exhibits the fastest growth, primarily due to population expansion, improving healthcare access, and rising acceptance of hormonal contraceptives.

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Key Market Drivers

1. Demographic and Societal Trends
The global increase in women of reproductive age sustains demand. Urbanization and changing social attitudes toward family planning bolster acceptance and utilization rates of hormonal contraceptives like ethinyl estradiol; levonorgestrel [2].

2. Advancements in Formulation and Delivery
Innovations have extended beyond oral pills to include extended-cycle, low-dose, and user-friendly delivery forms, enhancing patient compliance and expanding market scope [3].

3. Regulatory Approvals and Patent Expirations
Patents protect major formulations; however, upcoming patent expirations are facilitating entry by generic manufacturers, intensifying market competition and driving down prices [4].

4. Expansion of Over-the-Counter (OTC) Availability
Transitioning certain formulations to OTC status in jurisdictions like the United States is poised to augment sales volume, although regulatory hurdles persist [5].

5. Increasing Awareness and Education
Public health campaigns and education initiatives elevate awareness of contraception options, further stimulating demand.

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Challenges and Barriers

1. Regulatory and Legal Hurdles
Stringent approval processes and varying national regulatory requirements impede market entry and limit innovation. Additionally, legal restrictions in certain regions constrain OTC availability [6].

2. Side Effect Profile and Safety Concerns
Risk of adverse effects such as thromboembolism can deter use, influence prescribing patterns, and prompt regulatory scrutiny.

3. Competition from Alternative Contraceptive Methods
Multi-modal contraception—barrier methods, intrauterine devices (IUDs), implants—continues to compete, particularly as technology evolves.

4. Cultural and Religious Opposition
In some regions, social stigmas and religious beliefs influence contraceptive adoption, affecting market expansion.

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Competitive Landscape

The market features both multinational pharmaceutical giants and regional players. Major companies like Bayer, Teva, and Allergan dominate with established brands such as Yasmin, Nordette, and Levlen. Generics account for approximately 60–70% of sales, emphasizing the price-sensitive nature of the market [7].

Emerging players focus on niche formulations—low-dose, extended-cycle, or triphasic pills—to differentiate amidst intense price competition. Strategic collaborations with health agencies and investment in R&D for novel delivery methods are ongoing.

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Financial Trajectory and Forecast

Market Growth Factors:
Growing demand from emerging markets, OTC transition opportunities, and incremental innovation will sustain revenue streams. As patent protection wanes, generics will catalyze volume-based growth.

Revenue Trends:
Between 2022 and 2027, revenues are expected to increase at a CAGR of around 4%, driven by volume expansion rather than price hikes due to intense price competition from generics.

Profitability Outlook:
While brand-name formulations command higher margins, the market shift toward generics compresses profit margins. Companies invested in cost-effective manufacturing and supply chain optimization will better capitalize on the growth trajectory.

Impact of Patent Expirations:
Major patents expiring over the next five years will lead to a proliferation of generic options, possibly reducing prices by up to 30%. This intensifies competition and potentially diminishes overall industry margins but opens opportunities for new entrants and product variants.

Regulatory and Policy Effects:
Policy initiatives favoring OTC contraceptives could catalyze rapid revenue surges, though regulatory reimbursement and approval processes may delay such gains, particularly in highly regulated markets like the U.S. and Europe.

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Future Outlook and Opportunities

The market is poised for steady expansion, with significant opportunities in emerging markets, novel formulation research, and increased OTC availability. Investment in biotechnological innovations—such as slow-release implants, bio-adsorbable patches, or oral contraceptives with minimized side effects—are anticipated to redefine the landscape.

Furthermore, increasing integration of digital health solutions for adherence monitoring and personalized contraception counseling presents an ancillary growth avenue. Strategic partnerships between pharma companies and healthcare providers will be pivotal in expanding access and market penetration.

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Conclusion

The pharmaceutical market for ethinyl estradiol; levonorgestrel is characterized by resilience, driven by demographic shifts, innovation, and expanding access. However, impending patent expirations, fierce generic competition, and regulatory complexities temper growth projections. Stakeholders leveraging innovation, cost-efficiency, and expanded accessibility are better positioned for sustained profitability amid evolving market dynamics.

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Key Takeaways

• The global contraceptive market including ethinyl estradiol; levonorgestrel is expected to grow steadily (~4% CAGR) through 2027, primarily driven by emerging markets and innovation.
• Patent expirations will increase generic competition, reducing prices but expanding market volume.
• Opportunities lie in OTC formulations, novel delivery systems, and digital health integration, with regulatory hurdles being a key consideration.
• Manufacturers must optimize manufacturing costs and diversify formulations to remain competitive.
• Strategic partnerships and geographic expansion are essential for capitalizing on unmet demand in developing economies.

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FAQs

1. How do patent expirations influence the market for ethinyl estradiol; levonorgestrel?
Patent expirations open the market to generic manufacturers, increasing competition and reducing prices. While this can compress margins for brand-name companies, it enhances accessibility and volume sales, fostering overall market growth.

2. What advancements are expected in contraceptive formulations based on ethinyl estradiol and levonorgestrel?
Future formulations may include extended-cycle, low-dose, and non-oral delivery systems such as patches, implants, or vaginal rings that improve compliance and reduce side effects.

3. How is OTC availability impacting market growth?
Transitioning contraceptives to OTC status broadens access, especially among younger and underserved populations, potentially leading to significant volume increases despite regulatory challenges.

4. What regional factors influence the market outlook?
North America and Europe lead due to high acceptance and infrastructure, while Asia-Pacific offers rapid growth potential driven by demographic changes and expanding healthcare services.

5. Are there safety concerns impacting the market?
Yes, the risk of adverse cardiovascular events, especially thromboembolism, remains a concern and influences regulatory decisions, prescribing habits, and consumer acceptance.

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References

[1] MarketWatch, "Combined Oral Contraceptives Market Size & Forecast," 2022.
[2] WHO, "Reproductive Health," 2021.
[3] Expert Review of Pharmacoeconomics & Outcomes Research, "Formulation Innovations in Contraception," 2020.
[4] U.S. Patent and Trademark Office, "Patent Analysis for Contraceptive Medications," 2022.
[5] FDA, "Over-the-Counter Contraceptive Approval Process," 2022.
[6] International Regulatory News, "Barriers to Contraceptive Innovation," 2021.
[7] IMS Health, "Generic Contraceptive Market Share Report," 2022.