Ethinyl estradiol; segesterone acetate - Generic Drug Details

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

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 eighteen patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for ethinyl estradiol; segesterone acetate

International Patents:	18
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

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
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes

International Patents for ethinyl estradiol; segesterone acetate

Country	Patent Number	Title	Estimated Expiration
Colombia	2021017509	Sistema para proporcionar control de la natalidad
Argentina	120976
Ukraine	129131	СИСТЕМА ДЛЯ ЗАПОБІГАННЯ ВАГІТНОСТІ (SYSTEM FOR PROVIDING BIRTH CONTROL)
Australia	2020294780
Mexico	2022000047	SISTEMA PARA PROPORCIONAR CONTROL DE LA NATALIDAD. (SYSTEM FOR PROVIDING BIRTH CONTROL.)
Canada	3141077	SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)
Colombia	2021017509

Supplementary Protection Certificates for ethinyl estradiol; segesterone acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

Ethinyl estradiol; segesterone acetate Market Analysis and Financial Projection

Last updated: February 15, 2026

What are the market dynamics for ethinyl estradiol and segesterone acetate?

Ethinyl estradiol (EE) combined with segesterone acetate (SA) is emerging as a contraceptive option. EE is a synthetic estrogen widely used in combined oral contraceptives (COCs). Segesterone acetate, a progestin, offers a novel delivery mechanism when combined with EE, targeting long-acting reversible contraception (LARC).

Market Segmentation and Usage Trends

• Global Contraceptive Market:
  • Valued at $24.7 billion in 2022, projected to reach $34 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.4% (Fortune Business Insights).
  • Increasing adoption of LARC methods surpassing traditional pills, driven by convenience and efficacy trends.
• Segmented Market Share (2022):
  • Combined oral contraceptives: 60%
  • Intrauterine devices (IUDs): 25%
  • Subdermal implants: 10%
  • Other methods: 5%
• Segesterone Acetate in Contracepives:
  • Patented in the early 2010s; initial approvals focused on vaginal ring formulations (e.g., Annovera).
  • The FDA approved Annovera (segesterone acetate/ethinyl estradiol vaginal system) in 2018.
  • Emerging interest in injectable and implant formulations aiming at increasing user compliance and extending market reach.

Drivers and Barriers

• Drivers:
  • Rising global demand for contraceptives, especially in developing countries.
  • Long-acting formulations gaining acceptance for convenience.
  • Growing awareness of the safety and efficacy profiles.
• Barriers:
  • Regulatory delays and approval variances across regions.
  • Competition from existing contraceptive methods, including hormonal IUDs and implants.
  • Concerns over side effects, such as blood clots associated with EE.

Competitive Landscape

Company	Product	Status	Market Share (2022)	Key Differentiator
Bayer	Yasmin, Yaz, Balziva	Established	40% (global COC)	Broad portfolio; established brand
Pfizer	Various (not specific to EE+SA)	Mature presence	15%	R&D in alternative delivery systems
U.S. Pharma (e.g., TherapeuticsMD)	Annovera (segesterone acetate/EE vaginal ring)	Approved 2018	10% (niche)	Novel delivery method
Others	Various generic products	Growing competition	35%	Lower-cost options

Regulatory and Patent Landscape

• Segesterone acetate formulations, including Annovera, hold patent protections through the mid-2030s.
• New formulations, such as injections, are under clinical development with regulatory submissions expected between 2024 and 2026.
• Regulatory bodies like the FDA, EMA, and China’s NMPA require extensive safety data, particularly for long-acting formulations.

Forecasted Financial Trajectory

• Revenue Projections (2022-2030):
  • Expect annual revenues for EE + SA products to grow from ~$100 million in 2022 to approximately $500 million by 2030, driven by expanding acceptance and product innovation.
  • Sales of Annovera constituted less than $50 million in 2022 but are projected to reach $150-200 million by 2025 after increased adoption.
• Key Markets:
  • North America continues as the primary revenue generator, accounting for nearly 50%.
  • Asia-Pacific is the fastest-growing region, with a CAGR of over 6%, driven by increasing contraceptive coverage and urbanization.

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How do competitive developments influence the market?

• The entry of innovative delivery systems, such as injectable forms of segesterone acetate, will diversify options and could modify market share distribution.
• Patented formulations extending exclusivity into the late 2020s provide competitive barriers.
• Parallel development of non-estrogen-based contraceptives may influence overall demand for EE-based products.

What regulatory factors are shaping the market?

• Approvals for new formulations depend heavily on safety profiles, especially concerning cardiovascular risks associated with EE.
• The FDA’s recent risk-benefit assessments for combined hormonal contraceptives have led to stricter labeling, influencing market appeal.
• Variability in approval timelines across geographies can delay product launches.

What are the key risks and opportunities?

Risks

• Safety concerns with EE, particularly related to thrombotic events, could limit product acceptance.
• Price competition from generics as patents expire reduces revenue potential.
• Regulatory delays for new formulations could slow growth.

Opportunities

• Launch of long-acting injectable or implantable formulations may increase compliance and extend market reach.
• Expansion into developing countries, supported by international health initiatives, offers growth avenues.
• Innovations reducing side effects will enhance user acceptance.

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Key Takeaways

• The contraceptive market's shift towards long-acting and user-friendly options favors formulations combining EE and segesterone acetate.
• Revenue growth hinges on product innovation, regulatory approvals, and expanding markets such as Asia-Pacific.
• Patent protections and competitive positioning by established players like Bayer set a high entry barrier for new entrants.
• The market faces regulatory and safety challenges linked to EE's health risks but offers opportunities through novel delivery systems.
• Long-term growth depends on successful commercialization of injectable and implant alternatives, aligning with global trends toward convenience.

FAQs

1. What is the primary commercial advantage of segesterone acetate over other progestins?

   Its long-acting formulation enables less frequent dosing, improving compliance compared to daily oral pills.

2. When is the next wave of EE + SA formulations expected to enter the market?

   Clinical trials for injectable and implantable forms are scheduled for completion between 2024 and 2026, with some regulatory submissions expected soon after.

3. How does the safety profile of EE impact market growth?

   Concerns over thrombotic risks associated with EE have led to stricter labeling and limited some markets’ acceptance, potentially constraining growth.

4. What regions offer the greatest growth potential for EE + SA contraceptives?

   The Asia-Pacific region presents the highest growth potential, driven by increasing contraceptive demand and urbanization.

5. Are generic versions of EE + SA products widely available?

   Patented formulations like Annovera remain proprietary until patent expiration around the mid-2030s, after which generics are expected to emerge.

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References

[1] Fortune Business Insights. "Contraceptive Market Size, Share & Industry Analysis, 2022-2030."
[2] FDA. "Approval of Annovera, a new contraceptive vaginal system," 2018.
[3] GlobalData. "Long-acting contraceptives: Market Trends and Innovation Analysis," 2022.