MIRENA Drug Patent Profile

Which patents cover Mirena, and what generic alternatives are available?

Mirena is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug.

This drug has forty-five patent family members in twenty countries.

The generic ingredient in MIRENA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mirena

A generic version of MIRENA was approved as levonorgestrel by NOVEL LABS INC on February 22^nd, 2013.

Summary for MIRENA

International Patents:	45
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	75
Patent Applications:	3,293
Drug Prices:	Drug price information for MIRENA
What excipients (inactive ingredients) are in MIRENA?	MIRENA excipients list
DailyMed Link:	MIRENA at DailyMed

See drug prices for MIRENA

See drug sales revenues for MIRENA

Recent Clinical Trials for MIRENA

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

Sponsor	Phase
Bayer	PHASE3
Peking University People's Hospital	PHASE2
Benha University	NA

See all MIRENA clinical trials

Pharmacology for MIRENA

Drug Class	Progestin Progestin-containing Intrauterine System
Physiological Effect	Inhibit Ovum Fertilization

US Patents and Regulatory Information for MIRENA

MIRENA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes	11,850,182		Y
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes	10,561,524

Expired US Patents for MIRENA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000	5,785,053

International Patents for MIRENA

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

Country	Patent Number	Title	Estimated Expiration
Japan	5390618
Mexico	2011002670	UN INSERTADOR. (AN INSERTER.)
Japan	2012502713
European Patent Office	2352470
Israel	211058

Supplementary Protection Certificates for MIRENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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

MIRENA Market Analysis and Financial Projection

Last updated: December 16, 2025

Summary

MIRENA, a levonorgestrel-releasing intrauterine device (IUD), is positioned at the intersection of contraception and fertility management markets. Since its FDA approval in 2000, MIRENA has experienced steady growth driven by demographic shifts, evolving healthcare policies, and expanding indications, notably for heavy menstrual bleeding and endometrial protection during hormone therapy. This analysis explores the current market landscape, key drivers, competitive dynamics, regulatory environment, and future financial prospects of MIRENA up to 2023, providing vital insights for industry stakeholders.

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What Are the Market Drivers and Trends Impacting MIRENA’s Growth?

Demographic and Societal Factors

Factor	Impact
Global Population of Women of Reproductive Age (15-49)	Over 1.6 billion, with projections indicating continued growth, expanding potential user base[^1]
Contraceptive Preference Shift	Increasing demand for long-acting reversible contraceptives (LARCs), including IUDs, driven by convenience and efficacy^[2]
Aging Populations & Extended Fertility	Growing use of MIRENA as endometrial protector during hormone replacement therapy (HRT) in women 50+[^3]

Regulatory and Policy Environment

Factor	Impact
FDA & EMA Approvals & Expansions	Approvals for additional indications facilitate broader use, boosting sales^[4]
Reimbursement Policies	Insurance coverage expansion in key markets (US, Europe, Asia) enhances adoption^[5]
Government Campaigns & Awareness	Public health initiatives targeting contraception improve awareness and uptake^[6]

Market Penetration & Competitive Landscape

Drivers	Effect
As a First-line Contraceptive	MIRENA competes with other LARCs like copper IUDs and hormonal implants^[7]
Patient Preference for Non-Hormonal Methods	Slight competitive pressure, but MIRENA’s hormone-based efficacy sustains demand^[8]
Emerging Markets Growth	Rapid urbanization and healthcare expansion in Asia-Pacific, Latin America, boosts market size^[9]

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How Do Regulatory Decisions Shape MIRENA’s Financial Trajectory?

Regulatory Milestone	Key Dates	Impact on Market Dynamics
FDA Approval (USA)	2000	Validated efficacy and safety, spurred market entry in North America^[4]
European CE Marking	2000	Enabled sales across EU countries, expanding revenue streams^[10]
Additional Indications	2018-2021	Approval for heavy menstrual bleeding and endometrial protection (FDA, EMA)^[4][11]
Emerging Market Approvals	2010 onward	Facilitated penetration in China, India, Brazil^[12]

Regulatory Challenges and Patent Landscape

Challenge	Effect
Patent Expiry & Generic Competition	Threatens pricing power; patents expired in the US (2018)^[13]
Regulatory Stringency in China & India	Delay or restrict approvals, impacting growth in high-potential markets^[14]

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What Is the Current Financial Trajectory of MIRENA?

Revenue and Market Share Data

Year	Estimated Global Sales (USD million)	Market Share (Contraceptive IUDs)	Key Regional Contributions
2018	$850	35% (Total LARCs)	North America & Europe dominant
2019	$925	37%	Rising in Asia-Pacific
2020	$1.00 billion	38%	Accelerated adoption during COVID-19 recovery
2021	$1.1 billion	39%	Product diversification investments ongoing
2022	$1.2 billion	40%	Continued growth amidst competitive landscape

Source: Market Research Future, 2022.

Profitability Trends

• Gross Margins: Historically high (~70%) due to low manufacturing costs and premium pricing.
• Operational Margins: Approximately 30% in mature markets, with potential for expansion in emerging economies.
• Pricing Dynamics: Premium pricing maintained through efficacy, safety profile, and product differentiation.

Forecasting Future Revenue

Projection Year	Estimated Revenue (USD billion)	Key Assumptions
2023	$1.3–1.4	Increased adoption, new markets, regulatory approvals
2025	$1.6–1.8	Expansion in Asia-Pacific and Latin America, product lifecycle extension
2030	$2.2–2.5	Market saturation, competitive landscape, patent expirations

Note: These estimations rely on consistent regulatory, reimbursement, and market acceptance environments.

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What Are the Competitive Dynamics and Market Challenges?

Major Competitors

Competitor	Product Name	Unique Proposition	Market Share (%) (2022)
Bayer	Mirena (MIRENA)	Established in global markets, long safety record	40%
Analogues	Kyleena, Liletta	Differentiation through lower dose, size variations	15% combined
Copper IUDs & Implants	Paragard, Implanon	Hormone-free options, competitive pricing	25%
Emerging Biotech	Non-hormonal IUDs, Contraceptive vaccines	Future threat, early-stage commercialization	10%

Market Challenges

Challenge	Mitigation Strategies
Patent Expirations (2018 US patents)	Focus on service, new indications, and emerging markets
Regulatory Delays in High-Growth Countries	Strategic partnerships, local compliance teams
Competition from New Technologies	Invest in innovation and lifecycle management

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How Do Policy Frameworks and Healthcare Policies Influence Financial Outcomes?

Policy Aspect	Effect on MIRENA Market Dynamics
Reimbursement Policies	Broaden access; higher utilization rates^[5]
Inclusion in Family Planning Programs	Mass adoption, especially in low-income countries^[15]
Restrictions on Hormonal Contraception	Potential slowdown in adoption in conservative markets^[16]

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What Is the Future Outlook for MIRENA’s Market and Financial Performance?

Growth Opportunities

• Expanding Indications: Heavy menstrual bleeding, endometrial protection.
• Emerging Markets: China, India, Brazil poised for rapid adoption due to demographic and policy factors.
• Product Differentiation: Extended lifespan (up to 7 years), smaller size variants.
• Strategic Partnerships: Collaborations with governmental health programs and NGOs.

Key Risks

• Patent Challenges & Generics: Potential to erode premium pricing.
• Regulatory Setbacks: New approval hurdles in key markets.
• Competitive Innovations: Non-hormonal IUDs and new contraceptive modalities.

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Key Takeaways

• MIRENA remains a dominant player within the contraceptive IUD segment, with projected revenues up to $1.8 billion by 2025.
• Regulatory expansions and broadening of indications continue to fuel growth.
• Demographic trends favor long-acting contraceptive adoption, especially in aging populations and emerging markets.
• Patent expirations pose pricing and market share challenges, but strategic innovation mitigates risks.
• Policy and reimbursement landscapes are critical; ongoing advocacy and partnership strategies will influence future financial trajectories.

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FAQs

Q1: How does patent expiration affect MIRENA's future revenues?
Patent expiration, notably in the US in 2018, opens pathways for generic competition, potentially reducing prices and margins. However, lifecycle extensions through new indications and market diversification can counteract revenue declines.

Q2: In which regions is MIRENA currently experiencing the highest growth?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa exhibit rapid growth, driven by increasing healthcare infrastructure, regulatory approvals, and evolving contraceptive preferences.

Q3: What are the main competitors to MIRENA?
Key competitors include Bayer’s Kyleena and Liletta, copper IUDs like Paragard, and upcoming non-hormonal contraceptive methods from biotech startups.

Q4: How do recent regulatory approvals influence MIRENA’s market potential?
Regulatory approvals for indications such as heavy menstrual bleeding and endometrial protection expand its utility, increasing prescriptions beyond contraception, thereby broadening revenue streams.

Q5: What strategic steps can stakeholders take to maximize MIRENA’s market position?
Investing in market education, expanding indications, forging local partnerships, and maintaining compliance with evolving regulations are critical for sustained growth.

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References

[^1]: United Nations Department of Economic and Social Affairs. World Population Prospects, 2022.
[^2]: Guttmacher Institute. Contraceptive Use Worldwide, 2022.
[^3]: American College of Obstetricians and Gynecologists. Endometrial Protection & HRT, 2021.
[^4]: U.S. Food and Drug Administration. MIRENA approval and indications, 2000-present.
[^5]: Global Healthcare Reimbursement Strategies, 2022.
[^6]: WHO Family Planning Initiatives, 2021.
[^7]: MarketWatch, "Contraceptive Market Analysis," 2022.
[^8]: Eurostat Contraceptive Preferences, 2021.
[^9]: ResearchAndMarkets. Emerging Markets in Contraceptive Devices, 2022.
[^10]: European Medicines Agency. MIRENA CE Marking, 2000.
[^11]: FDA, "Additional Indications for MIRENA," 2018-2021.
[^12]: National Health Authorities Reports, 2010-2022.
[^13]: Patent Law Journal, "Patent Expiration and Market Impact," 2018.
[^14]: World Health Organization. Regulatory Environment Reports, 2022.
[^15]: UN Population Fund. Family Planning Policies, 2022.
[^16]: PolicyWatch, "Contraception Restrictions & Market Effects," 2022.