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	2012502713
Croatia	P20130510
Poland	178474
Spain	2424984

Supplementary Protection Certificates for MIRENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Market Dynamics and Financial Trajectory for MIRENA

Last updated: November 20, 2025

Introduction

MIRENA (levonorgestrel-releasing intrauterine system, or LNG IUS) stands out as a leading contraceptive device with a growing footprint across global markets. Launched by Bayer, MIRENA's unique combination of efficacy, safety, and long-term protection has positioned it as a preferred choice in reproductive health. This analysis explores the market dynamics influencing MIRENA’s revenue streams, regulatory landscape, competitive positioning, and future financial prospects.

Market Overview and Adoption Trends

The global contraceptive market, valued at approximately USD 21 billion in 2022, is characterized by shifting consumer preferences, technological innovation, and expanding access in emerging economies. MIRENA, with its hormonal intrauterine device (IUD) technology, has experienced rising adoption, especially among women seeking highly effective, reversible contraception.

Key drivers include increasing awareness of long-acting reversible contraceptives (LARCs), governmental initiatives promoting family planning, and technological advancements reducing insertion discomforts. Notably, the U.S. Food and Drug Administration (FDA) approved MIRENA in 2000—making it one of the earliest LNG IUS options—and its subsequent approvals in numerous countries have broadened its market access.

Emerging markets, including Asia-Pacific and Latin America, contribute significantly to growth, fueled by population expansion and improving healthcare infrastructure. According to recent market research, the LNG IUS segment is projected to grow at a compound annual growth rate (CAGR) of approximately 7% through 2027[1].

Regulatory Environment and Market Expansion

Enhanced regulatory pathways and multi-year device approvals have supported MIRENA's market expansion. The European Medicines Agency (EMA) granted approval in Europe, and subsequent approvals in countries like India and Brazil have bolstered global reach.

Regulatory challenges, however, persist. Variations in approval processes and reimbursement policies influence sales velocity. For instance, in the U.S., reimbursement justifications through insurer coverage play a critical role—favorable policies have notably driven prescriptions.

Strategic efforts by Bayer in conducting post-market surveillance, clinical studies, and educational campaigns further cement MIRENA's market position. The device also benefits from reimbursement schemes under national healthcare plans, which influence consumer uptake.

Competitive Landscape

MIRENA faces competition primarily from other intrauterine devices and hormonal contraceptives. Major competitors include:

• Skyla (bacterial bioresorbable IUDs)
• Kyleena (levonorgestrel-releasing IUD, lower dose)
• Liletta (similar to MIRENA, mainly in the U.S.)
• Copper IUDs (non-hormonal alternatives)

While Liletta and Kyleena offer lower-cost options, MIRENA maintains command due to its longer duration (up to 5 years) and proven efficacy. Non-hormonal IUDs pose an alternative but struggle with hormonal-related side effects, giving MIRENA an advantage among specific patient segments.

Bayer’s focus on innovation—such as reducing the size of devices, enhancing insertion procedures, and extending duration to 7 years—could bolster its competitive advantage.

Financial Trajectory and Revenue Drivers

MIRENA’s revenue trajectory hinges on several factors:

1. Market Penetration and Volume Growth

The global increase in women opting for LARCs offers fertile ground for MIRENA’s growth. Bayer continues to expand its distribution channels via partnerships with healthcare providers, clinics, and government health programs. Strategies targeting adolescent, postpartum, and underserved populations aim to boost adoption rates.

2. Pricing and Reimbursement Policies

Pricing strategies are calibrated to maximize profitability while maintaining affordability. In high-income markets like the U.S. and Europe, premium pricing persists for innovative features. Reimbursement coverage significantly affects sales volume, especially in publicly funded healthcare systems.

3. Product Lifecycle and Innovation

Product innovation, including extended durations and improved comfort, prolongs market relevance and supports premium pricing. The planned release of next-generation devices, coupled with educational and marketing initiatives, is expected to sustain revenue streams.

4. Competitive Pressure and Patent Dynamics

Patent protection around MIRENA’s formulation and delivery system provides temporary exclusivity. The retrieval of patent protections or introduction of biosimilars could erode market share, necessitating innovation and brand differentiation.

5. Regulatory Approvals and Off-Label Uses

Enhanced regulatory approvals in new markets expand MIRENA’s reach. Off-label uses, such as management of heavy menstrual bleeding, diversify revenue streams further—although they could be subject to regulatory scrutiny.

Based on market growth rates and historical sales data, MIRENA’s revenue in key markets has shown steady growth, with global sales surpassing USD 600 million in 2022, representing multiple years of CAGR above 7%[2].

Future Outlook and Financial Predictions

Several factors underpin the optimistic forecast:

• Anticipated approval in new jurisdictions—particularly in Africa and Southeast Asia—will unlock additional revenue.
• Increasing acceptance of hormonal LARCs will sustain growth in mature markets.
• Bayer's pipeline investments in device improvements and potential combination therapies could extend product lifecycle and diversify income sources.

Analysts project MIRENA’s revenues to reach approximately USD 0.8–1 billion globally by 2025, driven by sustained market penetration and the expansion into new demographic segments. Profit margins are expected to remain stable or improve due to scale efficiencies and device innovation.

However, risks include generic competition post-patent expiry, regulatory delays, and reimbursement constraints, which could temper growth.

Conclusion

MIRENA’s market dynamics are shaped by demographic shifts, technological advancements, and evolving healthcare policies. Its financial trajectory appears robust, supported by expanding demand for effective contraceptive solutions and strategic innovation. Bayer’s focus on penetration in emerging markets and product differentiation positions MIRENA favorably to sustain growth in a competitive landscape.

---

Key Takeaways

• The global contraceptive market’s growth, particularly in LARCs, underpins MIRENA’s demand trajectory.
• Regulatory approvals and reimbursement policies are critical to expanding market access and sales volume.
• Competitive positioning relies on device longevity, innovation, and strategic marketing; patent protections are vital but temporary.
• Revenue projections anticipate a CAGR of 7–10% through 2025, potentially reaching USD 1 billion globally.
• Risks include patent cliffs, biosimilar entry, and regulatory or reimbursement hurdles.

---

FAQs

1. What differentiates MIRENA from other intrauterine devices?

MIRENA offers a hormone-releasing system with up to 5 years of effective contraception, combined with a proven safety profile, long-term efficacy, and adaptability for postpartum and adolescents segments, distinguishing it from copper IUDs and other hormonal devices.

2. What are the main challenges facing MIRENA’s market growth?

Challenges include patent expiration leading to biosimilar competition, pricing pressures, regulatory delays in emerging markets, and reimbursement restrictions that limit patient access.

3. How has Bayer supported MIRENA’s market expansion?

Through strategic marketing, clinical evidence generation, regulatory approvals, educational campaigns for providers, and collaborations with health systems, Bayer has enhanced MIRENA’s visibility and adoption.

4. In which markets does MIRENA have the highest growth potential?

Emerging markets in Asia-Pacific, Latin America, and Africa show significant growth potential due to expanding healthcare infrastructure, rising awareness, and government family planning initiatives.

5. What future developments could impact MIRENA’s financial performance?

Innovations extending durability, new formulations, expanded indications, and regulatory approvals in untapped markets could positively influence revenues. Conversely, patent expiration and biosimilar entry could pose risks.

---

Sources

1. MarketResearch.com, "Global Contraceptive Market Forecast," 2022.
2. Bayer financial reports, 2022.