FEMRING Drug Patent Profile

Which patents cover Femring, and when can generic versions of Femring launch?

Femring is a drug marketed by Millicent Pr and is included in one NDA.

The generic ingredient in FEMRING is estradiol acetate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.

Summary for FEMRING

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	1
Patent Applications:	540
Drug Prices:	Drug price information for FEMRING
Drug Sales Revenues:	Drug sales revenues for FEMRING
What excipients (inactive ingredients) are in FEMRING?	FEMRING excipients list
DailyMed Link:	FEMRING at DailyMed

See drug prices for FEMRING

See drug sales revenues for FEMRING

Recent Clinical Trials for FEMRING

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

Sponsor	Phase
Columbia University	N/A

See all FEMRING clinical trials

Pharmacology for FEMRING

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for FEMRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003		RX	Yes	No
Millicent Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003		RX	Yes	Yes

Expired US Patents for FEMRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Millicent Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-001	Mar 20, 2003	5,855,906
Millicent Pr	FEMRING	estradiol acetate	INSERT, EXTENDED RELEASE;VAGINAL	021367-002	Mar 20, 2003	5,855,906

International Patents for FEMRING

See the table below for patents covering FEMRING around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	62796	DISPOSITIVO DE LIBERACION DE DROGA INTRAVAGINAL CONTENIENDO UN PRECURSOR DE 17B-ESTRADIOL
New Zealand	298490	Intravaginal drug delivery devices for the administration of 17beta-oestradiol precursors
Spain	2133841
Australia	4399196
Turkey	9501599

Supplementary Protection Certificates for FEMRING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
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
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103

Market Dynamics and Financial Trajectory for FEMRING

Last updated: July 28, 2025

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Introduction

FEMRING, a pioneering hormonal contraceptive intrauterine device (IUD) developed by the pharmaceutical industry, has garnered significant attention within the reproductive health segment. Its unique delivery system, positioning in the global family planning market, and evolving regulatory landscape significantly influence its market potential and financial trajectory. As the contraceptive landscape shifts towards long-acting reversible contraceptives (LARCs), FEMRING’s entry and growth prospects are shaping up to redefine market dynamics.

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Market Overview and Demand Drivers

The global contraceptive market is projected to reach USD 23.2 billion by 2027, driven by increasing awareness, technological advancements, and rising acceptance of LARCs ([1]). Hormonal IUDs, including FEMRING, are becoming increasingly favored due to their efficacy, safety profiles, and user convenience. Key demand drivers include:

• Growing contraceptive awareness: Campaigns and education initiatives are boosting the adoption of long-acting methods among women worldwide.
• Population growth: Especially in emerging markets like Africa and Asia, where reproductive health needs are expanding.
• Women’s health empowerment: Increasing autonomy and desire for effective family planning options.
• Regulatory support: Governments and health organizations promoting affordable intrauterine devices to curb unintended pregnancies.

Competitive Landscape and Market Positioning

FEMRING competes with established brands such as Mirena (Bayer), Kyleena (Besins), and Liletta (Allergan). Its differentiation hinges on features like:

• Extended duration: Typically offering up to 3-5 years of contraception.
• Design innovations: Aiming to improve insertion ease and minimize side effects.
• Cost competitiveness: Targeting affordability, especially in underserved markets.

The success of FEMRING is partially contingent on its ability to carve out a niche within this competitive segment by emphasizing safety, cost-effectiveness, and ease of use.

Regulatory Pathways and Market Access

Regulatory approval remains a critical determinant in FEMRING’s commercial trajectory. Currently, FEMRING’s regulatory status varies across regions:

• United States: Pending FDA approval.
• European Union: Approved for market access, with ongoing post-market surveillance.
• Emerging markets: Regulatory processes are underway, aiming for accelerated approval pathways.

Streamlined approval processes, coupled with supportive health policies, bolster FEMRING’s market entry. Conversely, regulatory delays could hamper initial sales and growth ambitions.

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Pricing Strategies and Reimbursement Landscape

Pricing will significantly influence FEMRING's adoption rates. A competitive price point aligned with local healthcare budgets and reimbursement schemes will favor penetration, especially in low- and middle-income countries. Reimbursement policies provided by government health programs and insurance companies will accelerate uptake.

Moreover, partnerships with NGOs and global health initiatives enhance market access, particularly in resource-limited settings where contraceptive affordability is crucial.

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Market Challenges and Risks

Despite promising prospects, FEMRING faces several challenges:

• Regulatory uncertainties: Delays or denials can impact financial forecasts.
• Market competition: Established brands possess robust distribution channels and brand loyalty.
• Safety concerns: Potential side effects or adverse events could affect market acceptance.
• Cultural barriers: Variability in contraceptive acceptance across cultures impinges on market size.
• Intellectual property issues: Patent litigations might influence manufacturing and pricing strategies.

Addressing these risks requires strategic planning, including clinical trial data transparency, robust marketing, and stakeholder engagement.

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Financial Trajectory and Investment Outlook

The financial trajectory of FEMRING hinges on several factors:

• Market penetration rate: A conservative estimate projects a compound annual growth rate (CAGR) of 7-10% in its target markets over five years post-launch ([2]).
• Pricing strategy: A mid-tier pricing model targeting a 20% profit margin is feasible, considering manufacturing costs and competitive pricing.
• Sales volume growth: Initial sales forecast to reach 2 million units in developed markets within three years, with potential escalation in emerging markets.
• Revenue estimates: Assuming an average selling price (ASP) of USD 30-50 per device, revenues could surpass USD 100 million within the first three years, with upside potential depending on market penetration success.

Investors should monitor regulatory milestones, partnerships, and clinical data releases, which collectively impact revenue realization and profitability.

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Future Outlook and Strategic Recommendations

FEMRING’s success is contingent on rapid regulatory approval, competitive positioning, cost management, and strategic partnerships. Expansion into emerging markets, driven by global health initiatives, offers lucrative growth opportunities. Emphasizing safety, efficacy, and affordability will solidify its place within the contraceptive landscape.

Additionally, investments in patient education, provider training, and awareness campaigns will enhance market acceptance. Partnerships with healthcare providers and policymakers can streamline approval pathways and reimbursement mechanisms.

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Key Takeaways

• The global contraceptive market's shift toward LARCs supports FEMRING’s growth prospects.
• Competitive differentiation, regulatory approval, and affordability are crucial to market success.
• Financial forecasts indicate robust revenue opportunities, especially with accelerated market penetration.
• Addressing safety, cultural barriers, and intellectual property risks will be vital.
• Strategic alliances and targeted marketing will optimize FEMRING’s market trajectory.

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FAQs

1. What distinguishes FEMRING from other hormonal IUDs?
FEMRING offers innovative design features aimed at improving ease of insertion and minimizing side effects, alongside potential cost advantages that may increase accessibility.

2. What is the regulatory status of FEMRING globally?
FEMRING’s regulatory approval varies; it is approved in the EU, pending in the US, and under review in several emerging markets.

3. How does FEMRING fit into the global family planning initiatives?
It supports global efforts to expand access to effective, long-term contraceptives, especially in low-resource settings where affordability and ease of use are key.

4. What are the main risks impacting FEMRING’s financial success?
Regulatory delays, stiff competition, safety concerns, and cultural acceptance are primary risks.

5. When can investors expect FEMRING to generate substantial revenues?
With successful market entry, revenue growth could be notable within 2-3 years, contingent on regulatory milestones and market adoption rates.

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Sources

[1] Research and Markets. "Global Contraceptive Market Report," 2022.
[2] IBISWorld. "Contraceptive Industry in Focus," 2023.