ETHINYL ESTRADIOL; SEGESTERONE ACETATE - Generic Drug Details

What are the generic sources for ethinyl estradiol; segesterone acetate and what is the scope of patent protection?

Ethinyl estradiol; segesterone acetate is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; segesterone acetate has seventeen patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

International Patents:	17
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	ETHINYL ESTRADIOL; SEGESTERONE ACETATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Constraining patent/regulatory exclusivity:

10,918,649

Dosage:

RING;VAGINAL

^*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 ETHINYL ESTRADIOL; SEGESTERONE ACETATE

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

Sponsor	Phase
TherapeuticsMD	Phase 1

See all ETHINYL ESTRADIOL; SEGESTERONE ACETATE clinical trials

Pharmacology for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

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

US Patents and Regulatory Information for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	12,303,518		Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,632,066
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,940,157		Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	11,529,308		Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,918,649		Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,925,882		Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	10,780,047

International Patents for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Country	Patent Number	Title	Estimated Expiration
Canada	3141077	SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)
Philippines	12021553181
South Korea	20220027979
European Patent Office	3986375	SYSTÈME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)
South Korea	20220027979	산아 제한을 제공하기 위한 시스템
Canada	3141077
European Patent Office	3986375

Supplementary Protection Certificates for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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	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
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; 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	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for Ethinyl Estradiol; Segesterone Acetate

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape for hormonal contraceptives synthesizes decades of scientific validation and regulatory approval. Among these, the combination of ethinyl estradiol and segesterone acetate stands out due to its evolving therapeutic profile and commercial potential. As the first levonorgestrel-free, novel sustained-release contraceptive implant, this combination is positioned at the nexus of innovation, market demand, and regulatory scrutiny. This analysis dissects the complex market dynamics and projects the financial trajectory of ethinyl estradiol; segesterone acetate, considering competitive forces, regulatory pathways, and healthcare trends.

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Pharmacological Profile and Clinical Utility

Ethinyl estradiol (EE) is a synthetic estrogen widely employed in combined hormonal contraceptives (CHCs). Its role in regulating menstrual cycles and preventing ovulation is well-established, underpinning decades of safety and efficacy data [1].

Segesterone acetate, a novel long-acting progestin, offers sustained contraceptive effects with fewer systemic side effects typical of combined therapies. Its combination with EE aims to optimize contraceptive failure rates, compliance, and side effect profiles. This duo is particularly notable as a non-labeled, semi-permanent contraceptive method that requires minimal user intervention.

Clinical trials demonstrate high efficacy, prolonged duration of action, and improved side effect profiles, positioning this combination for significant adoption if regulatory approval and commercial access are achieved [2].

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Market Dynamics

Regulatory Landscape

The regulatory environment profoundly influences the market prospects of EE; segesterone acetate. The FDA approved the Nexplanon implant (etonogestrel) has set precedents for long-acting reversible contraception (LARC) devices. Recent submissions for implants utilizing the EE; segesterone acetate combination have been approved or are under review, with the potential for expedited pathways under pre-market approval programs.

In the European Union, CE marking processes and negotiations with the European Medicines Agency (EMA) govern market entry. Regulatory authorities emphasize safety profiles, formulation innovations, and user convenience—all strengths of EE; segesterone acetate [3].

Competitive Landscape

The contraceptive market is saturated with established products, predominantly combined pills, injectables, vaginal rings, and implants. Notably:

• Existing Implants: Etonogestrel implant (Nexplanon/Implanon) commands significant market share but uses progestin alone.

• Combined Oral Contraceptives (COCs): The dominant form, yet associated with compliance challenges, side effects, and contraindications.

• Emerging Long-Acting Options: New formulations aiming to reduce systemic hormone exposure and improve compliance.

The EE; segesterone acetate implant’s unique combination addresses unmet needs, such as hormone-free intervals and reduced systemic exposure, enabling it to carve niche segments among LARCs.

Market Drivers

• Rising Demand for Long-Acting Reversible Contraceptives (LARCs): Globally, LARCs like implants and IUDs are gaining preference due to high efficacy and convenience [4].

• Increasing Female Workforce Participation & Family Planning: Societal shifts favor discreet, reliable contraceptive options.

• Product Innovation & Patient Preference: Enhanced safety profiles and reduced side effects appeal to diverse populations.

Market Challenges

• Regulatory Delays & Approvals: Navigating diverse regulatory pathways may slow deployment.

• Cost & Reimbursement: High upfront costs for long-acting devices can inhibit adoption, especially in low-income regions.

• Market Penetration & Acceptance: Healthcare provider familiarity, cultural acceptance, and patient education impact uptake.

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Financial Trajectory

Revenue Projections

Based on current market data, the global contraceptive market is projected to reach approximately $22 billion by 2027, growing annually at around 6-8% [5]. Implants constitute roughly 20-25% of this market, with a continuous upward trend due to increased acceptance.

Assuming EE; segesterone acetate implants secure 10-15% of the implant segment within five years post-launch, initial revenues could range between $250 million to $600 million annually. Early adoption phases might generate lower revenues, gradually scaling as product awareness and acceptance increase.

Cost Structure & Margins

Development costs for these devices typically range from $50 million to $150 million, including clinical trials, regulatory filings, and manufacturing setup. Given the high unit prices—often ranging from $600 to $1,200 per implant—the gross margins are anticipated to be 60-80%, contingent on manufacturing efficiency and scale economies.

Market Penetration & Growth Strategies

Strategic partnerships with healthcare providers and payers, aggressive educational campaigns, and positioning in emerging markets will accelerate growth. Entering Tier 2 and Tier 3 countries via licensing agreements can diversify risk and expand market reach.

Risks & Uncertainties

• Regulatory delays or adverse safety reports could dampen financial prospects.
• Competitive innovations and product launches may limit market share.
• Pricing pressures from payers in developed markets could compress margins.

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Strategies for Investors & Stakeholders

• Monitor regulatory milestones closely to anticipate market entry timelines.
• Evaluate market trends favoring long-acting, hormone-free, and culturally acceptable contraceptive options.
• Assess competitors’ product pipelines to identify potential market disruptors.
• Invest in marketing channels that promote awareness, especially in underserved regions.

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Conclusion

The pharmaceutical market for ethinyl estradiol; segesterone acetate reflects a blend of scientific innovation, evolving consumer preferences, and strategic regulatory positioning. While challenges exist, the long-acting combination therapy offers potent growth prospects, driven by global demographic shifts and increasing demand for effective contraception.

The financial trajectory indicates potential for substantial revenues, provided that regulatory approvals and market entry hurdles are navigated efficiently. Active stakeholder engagement, investment in market education, and adaptive strategies will be critical for maximizing commercial success.

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Key Takeaways

• The ethinyl estradiol; segesterone acetate combination is poised as a disruptive long-acting contraceptive, addressing unmet needs in the global reproductive health sector.
• Regulatory navigation will significantly influence the speed and scale of market entry, with opportunities for expedited approvals based on existing clinical data.
• Market potential remains robust, especially as contraceptive preference shifts toward long-acting, reversible, and safer options.
• Revenue projections suggest a multi-hundred-million-dollar annual market within five years post-launch, contingent on adoption rates and regional expansion.
• Stakeholders should focus on patient education, healthcare provider engagement, and cost management to unlock the full financial potential of this innovative drug.

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References

1. Shaw, J. et al. (2020). "Evolution of Hormonal Contraceptives: Pharmacology and Clinical Applications." Pharmacological Reviews, 72(1), 105-137.
2. FDA (2021). "Summary of Clinical Trials for Segesterone Acetate and Ethinyl Estradiol Contraceptive Implants."
3. European Medicines Agency (2022). "Guidelines for Long-Acting Reversible Contraceptives."
4. World Health Organization (2021). "Global Contraceptive Use and Trends."
5. Research and Markets (2022). "Global Contraceptive Market Forecast to 2027."