ANNOVERA Drug Patent Profile

When do Annovera patents expire, and when can generic versions of Annovera launch?

Annovera is a drug marketed by Mayne Pharma and is included in one NDA. There are nine patents protecting this drug.

This drug has eighteen patent family members in seventeen countries.

The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Annovera

Annovera was eligible for patent challenges on August 10, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 21, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ANNOVERA

International Patents:	18
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for ANNOVERA
What excipients (inactive ingredients) are in ANNOVERA?	ANNOVERA excipients list
DailyMed Link:	ANNOVERA at DailyMed

See drug prices for ANNOVERA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANNOVERA

NDA:

209627

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 ANNOVERA

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

Sponsor	Phase
TherapeuticsMD	Phase 1

See all ANNOVERA clinical trials

Pharmacology for ANNOVERA

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ANNOVERA

ANNOVERA is protected by twelve US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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

International Patents for ANNOVERA

When does loss-of-exclusivity occur for ANNOVERA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Dominican Republic

European Patent Office

Israel

Japan

Mexico

Philippines

South Africa

South Korea

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ANNOVERA around the world.

Country	Patent Number	Title	Estimated Expiration
China	114364369	用于提供节育的系统 (System for providing birth control)
South Africa	202110288
World Intellectual Property Organization (WIPO)	2020257544
Ukraine	129131	СИСТЕМА ДЛЯ ЗАПОБІГАННЯ ВАГІТНОСТІ (SYSTEM FOR PROVIDING BIRTH CONTROL)

Supplementary Protection Certificates for ANNOVERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU 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
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ANNOVERA

Last updated: July 27, 2025

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Introduction

ANNOVERA (segesterone acetate and ethinylestradiol vaginal system) has emerged as a significant entrant in the contraceptive market, specifically targeting women seeking non-invasive, reversible birth control solutions. Approved by the U.S. Food and Drug Administration (FDA) in 2018, ANNOVERA stands out due to its unique delivery mechanism—an intravaginal ring administered quarterly. Its market evolution reflects broader shifts in women’s reproductive health, regulatory landscapes, and healthcare provider preferences. Analyzing the market dynamics and financial trajectory of ANNOVERA offers critical insights into its current positioning and future potential within the women's health pharmaceutical sector.

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Market Overview

Global and Regional Market Context

The global contraceptive market, valued at approximately $20 billion in 2022, is propelled by rising awareness, technological innovations, and increasing access to reproductive healthcare services [1]. North America remains the largest segment, driven by high contraceptive adoption rates and advanced healthcare infrastructure. The U.S. alone accounts for over 50% of the global market, emphasizing regional dominance.

Within this space, hormonal contraceptives—comprising pills, patches, rings, and implants—dominate market share. ANNOVERA, positioning itself as a vaginal ring, aligns with the rising preference for user-controlled, discreet, and long-acting contraceptive options. The concurrent increase in women’s reproductive autonomy and preferences for flexible healthcare solutions fuels the product's growth prospects.

Market Drivers

• Product Differentiation: ANNOVERA offers a quarterly, discreet alternative to daily pills or invasive implants, aligning with consumer demand for convenience.
• Regulatory Approval: FDA approval in 2018 established a significant market entry point, enabling commercialization and clinician adoption.
• Increasing Female Workforce Participation: More women seek long-term, reversible contraception that accommodates busy lifestyles.
• Advances in Formulation and Delivery: Innovations that improve safety, efficacy, and user comfort bolster market acceptance.

Market Challenges

• Competition from Established Brands: Oral contraceptives like Ortho Tri-Cyclen, NuvaRing, and IUDs maintain dominant market shares.
• Limited Awareness and Physician Adoption: As a relatively new product, clinician familiarity and prescribing patterns evolve more slowly.
• Pricing and Reimbursement: Cost barriers and insurance coverage variability impact patient uptake.
• Adverse Effects and Contraindications: Potential side effects, including hormonal-related risks, can inhibit adoption amongst some patient segments.

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Financial Trajectory

Revenue Generation and Market Penetration

Since its launch, ANNOVERA has experienced moderate but steady revenue growth within a competitive landscape. As a prescription product, its sales are directly correlated with physician prescribing behaviors and patient acceptance.

• Sales Metrics: Initial sales in 2019 estimated at approximately $15-20 million. These figures reflect early-stage penetration, primarily within the U.S.
• Growth Trajectory: Industry estimates project a compound annual growth rate (CAGR) of approximately 10-15% over the next five years, contingent on expanding awareness, clinician endorsements, and reimbursement strategies [2].
• Market Penetration Strategies: The manufacturer invests in education campaigns targeting healthcare providers and patients, along with partnerships with OB-GYN clinics to foster adoption.

Pricing Dynamics

ANNOVERA's pricing varies regionally, but in the U.S., the average retail price ranges between $150 to $250 per cycle. Insurance coverage significantly influences out-of-pocket costs, with commercial plans increasingly incorporating the product for reproductive health coverage.

Cost Structures

Manufacturing costs for ANNOVERA, including the innovative delivery system, are higher than traditional oral pills. However, economies of scale and production efficiencies are expected to improve profitability as market penetration increases.

Profitability Outlook

Given the current competitive landscape, immediate profitability remains vulnerable until the product achieves broader market share. However, as prescription pipelines expand and awareness improves, revenue streams are expected to strengthen, improving margins and enabling reinvestment into marketing and R&D.

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Market Dynamics Influencing Financial Trajectory

Regulatory Environment

The FDA’s fast-tracking mechanisms and approval pathways for hormonal contraceptives support timely market entry and relatively favorable regulatory conditions for ANNOVERA. Future approvals or label expansions could further influence sales potential.

Competitive Landscape

ANNOVERA contends with established contraceptives like Mirena (levonorgestrel IUD), NuvaRing, and hormonal pills. Market share distribution shifts in favor of ANNOVERA hinge on physician acceptance and patient preferences for less invasive, reversible options.

Social and Cultural Trends

Growing societal emphasis on women’s reproductive rights and autonomy are drivers of demand growth. Increasing acceptance of long-acting reversible contraceptives (LARCs) aligns with ANNOVERA’s product profile, positively influencing long-term financial outlook.

Insurance and Reimbursement Policies

Reimbursement frameworks heavily influence consumer access. Recent trends indicate expanding coverage for contraceptive options, including newer methods like ANNOVERA, which positively impacts revenue trajectories.

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Future Outlook

Growth Opportunities

• Global Expansion: While predominantly marketed in North America, regions with evolving contraceptive needs like Europe, Asia-Pacific, and Latin America present significant growth opportunities.
• Pipeline Development: Potential for label extensions to include additional indications or expanded age groups could dramatically boost revenue.
• Educational Campaigns: Increasingly targeted marketing and provider education can improve prescription rates.

Risks and Uncertainties

• Competitive Innovations: The emergence of new contraceptive technologies could curtail market share.
• Regulatory Changes: Potential shifts in healthcare policies or contraceptive mandates could impact sales.
• Patient Acceptance: Variability in user preferences regarding intravaginal delivery systems may influence market penetration.

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Key Takeaways

• Market Positioning: ANNOVERA occupies a unique niche with its quarterly, non-invasive contraceptive delivery, offering a competitive advantage in the women's health space.
• Growth Potential: Industry forecasts hinge upon increased provider adoption, patient awareness, and expansion into international markets.
• Financial Trajectory: Early revenues are modest, with significant upside potential driven by increased prescription volume, improved reimbursement, and broader market acceptance.
• Strategic Focus: Emphasizing education, expanding clinical data, and navigating regulatory landscapes will be critical for long-term financial success.
• Market Risks: Ongoing competition, regulatory hurdles, and patient preferences remain key uncertainties impacting revenue growth.

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FAQs

Q1: What factors differentiate ANNOVERA from other contraceptive methods?
ANNOVERA offers a quarterly, discreet intravaginal ring that provides hormonal contraception without daily pills or invasive implants, appealing to women prioritizing convenience and autonomy.

Q2: How has regulatory approval influenced ANNOVERA’s market potential?
FDA approval in 2018 facilitated market entry, built credibility, and enabled reimbursement negotiations, serving as a pivotal catalyst for initial sales and broader adoption.

Q3: What are the main challenges facing ANNOVERA’s financial growth?
Challenges include competition from established contraceptives, limited clinician familiarity initially, insurance coverage disparities, and patient acceptance of intravaginal delivery systems.

Q4: Can international markets significantly contribute to ANNOVERA’s revenue?
Yes, emerging markets with rising reproductive health awareness and improving healthcare infrastructure present substantial growth potential, contingent on regulatory approval and distribution partnerships.

Q5: What strategies are recommended to enhance ANNOVERA’s market share?
Increasing clinician and patient education, expanding clinical research, optimizing reimbursement coverage, and developing targeted marketing campaigns are essential for accelerating adoption.

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References

[1] MarketWatch, “Contraceptive Market Size & Trends,” 2022.
[2] Grand View Research, “Women’s Contraceptive Market Forecast,” 2023.