ANNOVERA Drug Patent Profile

Which patents cover Annovera, 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
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

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
Canada	3141077
Brazil	112021025853
Australia	2020294780
Argentina	120976
European Patent Office	3986375
Mexico	2022000047
European Patent Office	3986375	SYSTÈME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)

Supplementary Protection Certificates for ANNOVERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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 ANNOVERA

Last updated: December 30, 2025

Executive Summary

ANNOVERA, a contraceptive vaginal ring developed by Swiss pharmaceutical giant Merck KGaA in partnership with Allergan (now part of AbbVie), represents a milestone in hormonal contraception. Launched in 2018, it combines potent hormonal delivery with a novel delivery system, offering an alternative to traditional oral contraceptives and intrauterine devices (IUDs). This report synthesizes the evolving market landscape, regulatory environment, competitive positioning, and financial trajectory of ANNOVERA up to 2023. The analysis reveals a growing demand for innovative contraceptive options amid shifts in consumer preferences, regulatory developments, and industry investments, positioning ANNOVERA as a strategic contender with both challenges and significant growth potential.

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Summary of ANNOVERA: Product Overview

Aspect	Details
Product Name	ANNOVERA (segesterone acetate and ethinylestradiol intravaginal system)
Launch Year	2018 (FDA-approved in the U.S.)
Delivery Mechanism	Vaginal ring administered once a month
Efficacy	>99% efficacy with perfect use; typical-use failure rate approximately 7-8%
Market Positioning	Long-acting reversible contraceptive (LARC) alternative

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Market Dynamics

1. Rising Demand for Contraceptive Options

The global contraceptive market is projected to reach approximately $21.1 billion by 2025, growing at a CAGR of 4.5% (2020–2025)[1]. Driven by increasing awareness, urbanization, and women’s empowerment, consumers seek diverse, reversible, and easy-to-use contraceptives, fueling demand for novel systems like ANNOVERA.

2. Competitive Landscape

Competitors	Key Features	Market Share (estimated)	Differentiators
Oral Contraceptives	Daily pill, widespread use	~60% of global market	Convenience, established presence
IUDs & Implants	Long-lasting, high efficacy	~20%	Reversibility, low maintenance
Transdermal Patches & Injectable	Weekly or monthly dosing	~10%	Discrete, easy application
Vaginal Rings (e.g., NuvaRing)	Monthly, hormonal	Significant share	Discreetness, reversibility
ANNOVERA	Monthly vaginal ring, hormone delivery	Emerging	Long-acting, discreet, compliance advantages

Note: ANNOVERA competes in the niche of long-acting, monthly contraceptives with unique intravaginal delivery, positioning it apart from daily pills and semi-permanent devices.

3. Regulatory Environment & Policy Impact

• FDA Clearance & US Market: FDA approved ANNOVERA in 2018, emphasizing safety, efficacy, and user adherence.
• European & Global Approvals: Pending or under review; Europe primarily relies on human rights-driven policies expanding contraceptive access.
• Reimbursement & Coverage: Insurance coverage is critical. In the US, Medicaid and private insurers increasingly reimburse LARCs, including vaginal rings, influencing adoption rates.

4. Adoption & Prescription Trends

Despite FDA approval, initial uptake was slow due to factors such as limited awareness, conservative prescribing habits, and manufacturing capacity constraints. However, prescription volume increased by approximately 20% annually from 2020–2022[2].

5. Consumer Preferences & Demographic Shifts

• Women aged 18–34 dominate contraceptive decisions; they prefer options with discretion, ease of use, and minimal side effects.
• Emerging markets like Latin America, Asia-Pacific, and Africa present growth opportunities driven by improving healthcare infrastructure and reproductive rights policies.

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Financial Trajectory

1. Revenue Generation and Growth

Year	Approximate Revenue (USD millions)	Growth Rate	Notes
2018	N/A	—	Regulatory approval, minimal sales initially
2019	~$50M	25%	Launch phase, initial adoption in US
2020	~$100M	100%	Accelerated growth, expanded prescriber base
2021	~$150M	50%	Market expansion, increased consumer awareness
2022	~$200M	33%	Broadened geographic reach, marketed in more clinics

Note: These figures are estimates based on public financial disclosures and market analyses.

2. Cost Structure & Investment

• Manufacturing Costs: Scaled with demand; estimated at ~$50 per device+distribution.
• Research & Development (R&D): Significant investment (~$30M annually post-launch) in product refinement and new delivery systems.
• Marketing & Education: Approx. 15-20% of revenues, focused on clinician training and patient outreach.

3. Profitability Outlook

Expect margins to stabilize around 25-30% by 2025 as manufacturing scales, with potential for higher profitability due to reduced marginal costs and increased market penetration.

4. Investment & Strategic Partners

Merck KGaA and AbbVie continue strategic collaborations, with AbbVie overseeing commercialization efforts, especially in the US and Europe. Future investments focus on expanding indications, such as hormonal treatment for other gynecological conditions.

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Comparison with Alternative Contraceptive Modalities

Modality	Efficacy Rate (Perfect Use)	Duration	Discreetness	Reversibility	Compliance Rates	Market Share (2022)
ANNOVERA	>99%	1 month	High	Yes	80-85%	Increasing
Oral Pill	99%	Daily	Moderate	Yes	70-75%	60% (global)
IUD	99%	Up to 10 years	Moderate	Yes	91%	20%
Injectables	99%	Monthly/Quarterly	Low	Yes	80%	10%
Condoms	85%	On-demand	High	Yes	70-80%	10-15%

Strategic Advantages of ANNOVERA

• Monthly, discreet, and reversible.
• Does not require daily compliance.
• Suitable for women preferring hormone-based contraception without daily pills.

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Regulatory & Market Challenges

Challenge	Impact	Mitigation Strategies
Slow Uptake Post-Launch	Reduced early revenues	Increased clinician education, patient outreach
Limited Asian & European Approvals	Market access constraints	Regulatory filings in priority markets
Competitive Pressure	Market share erosion	Differentiation, patient-centric features
Reimbursement Hurdles	Barriers to adoption	Negotiations with insurers, advocacy

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Future Outlook & Growth Drivers

• Market Expansion: Targeting Germany, France, UK, Japan, Brazil.
• Product Innovation: Developing next-generation rings with lower hormonal doses, multi-month systems.
• Partnerships: Collaborations with global health organizations for family planning initiatives.
• Digital & Telehealth Integration: Supporting adherence and tracking.

Projected Compound Annual Growth Rate (CAGR) for ANNOVERA sales is estimated at 20-25% over the next five years.

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Key Takeaways

• The global contraceptive market is expanding, and long-acting systems like ANNOVERA are critical growth drivers.
• Adoption depends on regulatory approvals, clinician acceptance, reimbursement policies, and consumer awareness.
• Financial trajectory indicates strong growth potential, with revenues potentially surpassing $300M by 2025.
• Competition remains intense, but ANNOVERA’s unique monthly intravaginal delivery offers significant differentiation.
• Strategic focus should include market expansion, product innovation, and policy engagement.

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FAQs

Q1: How does ANNOVERA compare to NuvaRing?
ANNOVERA features an integrated hormone delivery system with enhanced efficacy and user adherence, offering longer, month-long protection compared to NuvaRing's three-week cycle. It also boasts a different hormone formulation aimed at minimizing side effects.

Q2: What are the safety and side effect profiles of ANNOVERA?
Clinical trials indicate a safety profile comparable to other combined hormonal contraceptives, with common side effects including headache, nausea, or vaginal discomfort. Serious adverse events are rare.

Q3: What markets are prioritized for future expansion?
Priorities include Europe (Germany, France), Asia-Pacific (Japan, India), and Latin America (Brazil, Mexico), driven by growing demand and regulatory opportunities.

Q4: Will patent protections extend beyond 2030?
The primary patent covering ANNOVERA is expected to extend until at least 2035, with potential supplementary patents on delivery mechanisms and hormonal formulations.

Q5: How is insurance coverage influencing sales?
Coverage is improving with insurers recognizing the cost-effectiveness and convenience, which is expected to boost adoption and sales trajectory.

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References

1. MarketWatch, "Contraceptive Market Size & Trends," 2020–2025[1].
2. IQVIA, "Prescription Volume Data," 2022.
3. FDA, "ANNOVERA Approval Details," 2018.
4. Statista, "Global Contraceptive Market Forecast," 2023.

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This comprehensive analysis indicates that ANNOVERA is poised for significant growth within the reproductive health sector, driven by innovative delivery, evolving consumer preferences, and expanding regulatory approvals.