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-three 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:	104
Clinical Trials:	71
Patent Applications:	3,711
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
University Health Network, Toronto	Phase 2
Arkansas Children's Hospital Research Institute	Phase 4
Peking University People's Hospital	Phase 2

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
Japan	2012502713
European Patent Office	2352470	DISPOSITIF D'INTRODUCTION (AN INSERTER)
Israel	211058	מחדיר (Inserter for ius)

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

MIRENA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mirena

Overview of Mirena

Mirena, a levonorgestrel-releasing intrauterine system (IUS), is a widely used contraceptive and therapeutic device indicated for the prevention of pregnancy for up to 5 years and the treatment of heavy menstrual bleeding. It is part of the Mirena product family, which also includes Kyleena and Jaydess, all manufactured by Bayer AG.

Market Position and Demand

Women's Healthcare Market Segment

Mirena is a significant player in the women's healthcare market, particularly in the contraceptives segment. The global women's healthcare market is projected to grow from USD 9.6 billion in 2019 to USD 17.8 billion by 2024, with a Compound Annual Growth Rate (CAGR) of 13.2% during the forecast period. Contraceptives, including Mirena, drive this growth due to their benefits and increasing demand among end users[4].

Competitive Landscape

In the contraceptives market, Mirena competes with other products such as NuvaRing, Ortho Tri-Cy Lo (28), and others. However, Mirena is widely accepted due to its minimal side effects and effectiveness, making it a preferred choice among users[4].

Financial Performance

Sales Growth

Mirena has shown significant sales growth in recent years. In the second quarter of 2024, sales of the Mirena product family advanced by 11.1% on a currency- and portfolio-adjusted basis, driven by higher volumes and prices, particularly in the United States and Brazil[2].

Revenue Contribution

The Pharmaceuticals Division of Bayer, which includes Mirena, reported higher sales in 2024. The division's sales rose by 4.5% to 4.605 billion euros, with Mirena contributing to this growth alongside other new products like Nubeqa™ and Kerendia™[2].

Financial Modeling and Valuation

Net Present Value (NPV) Model

GlobalData's NPV model provides a comprehensive valuation tool for pharmaceutical assets like Mirena. This model includes a forecasted Revenue Model, Patent Expiry Model, Operating Profit Model, Net Profit calculation, and Discounted Cash Flow analysis to derive the Net Present Value (NPV) of the drug. This tool is crucial for strategic decision-making around pharmaceutical assets[1].

Market Challenges and Opportunities

Market Challenges

Despite its success, Mirena faces several challenges, including:

• Reluctance to Use Contraceptives: In some regions, there is a reluctance to use contraceptives, which can impact sales[4].
• Legal and Regulatory Issues: Mirena has been involved in several lawsuits, including those related to organ perforation and pseudotumor cerebri. These legal issues can affect public perception and sales[5].

Market Opportunities

• Emerging Markets: Growing populations and increasing urbanization in regions like China and India present significant opportunities for Mirena. Government initiatives to curb population growth also drive demand for contraceptives[4].
• Increased Healthcare Expenditure: Improved healthcare expenditure in various countries supports the growth of the women's healthcare market, including the demand for Mirena[4].

Competitive Leadership and Market Share

Competitive Leadership

Bayer AG, the manufacturer of Mirena, is a visionary leader in the women's healthcare market. The company's strong portfolio and continuous innovation, such as advances in cell and gene therapy and chemoproteomics, position it for long-term success[4].

Market Share Analysis

Mirena holds a significant market share in the contraceptives segment. While Prolia is the largest and fastest-growing segment in the women's healthcare market, Mirena's acceptance and minimal side effects ensure its strong market presence[4].

Future Outlook

Group Outlook

Bayer has confirmed its 2024 outlook, with the Pharmaceuticals Division expected to continue its growth trajectory. The success of new products and the ongoing performance of established products like Mirena are key factors in this outlook[2].

Strategic Priorities

Bayer's focus on innovation, particularly in the Pharmaceuticals Division, is expected to drive future growth. Investments in early-stage research and advanced technologies will likely enhance the financial trajectory of Mirena and other pharmaceutical assets[2].

Key Takeaways

• Strong Sales Growth: Mirena has shown significant sales growth, driven by higher volumes and prices in key markets.
• Competitive Market Position: Mirena is widely accepted due to its minimal side effects and effectiveness, making it a preferred choice in the contraceptives market.
• Financial Modeling: GlobalData's NPV model provides a comprehensive tool for valuing Mirena and other pharmaceutical assets.
• Market Opportunities: Emerging markets and increased healthcare expenditure present significant opportunities for Mirena.
• Challenges: Mirena faces challenges such as reluctance to use contraceptives and legal issues, which need to be addressed.

FAQs

What is Mirena used for?

Mirena is used for the prevention of pregnancy for up to 5 years and the treatment of heavy menstrual bleeding[1].

How has Mirena performed in terms of sales?

Mirena has shown significant sales growth, with an 11.1% increase in the second quarter of 2024 on a currency- and portfolio-adjusted basis[2].

What are the key challenges facing Mirena?

Mirena faces challenges such as reluctance to use contraceptives, legal and regulatory issues, and market competition[4][5].

How does GlobalData's NPV model help in valuing Mirena?

GlobalData's NPV model provides a comprehensive valuation tool that includes revenue forecasts, patent expiry models, operating profit models, and discounted cash flow analysis to derive the Net Present Value of Mirena[1].

What are the future outlook and strategic priorities for Mirena?

Bayer has confirmed its 2024 outlook, with a focus on innovation and strategic priorities that are expected to drive future growth for Mirena and other pharmaceutical assets[2].

Sources

1. GlobalData: Net Present Value Model: Mirena/Kyleena/Jaydess - GlobalData
2. Bayer: Modest performance in challenging agricultural market environment – Group outlook confirmed
3. MedicalNewsToday: Mirena cost 2024: Coupons and more
4. GlobeNewswire: Women's Health Care Market by Drugs (Prolia, Xgeva, Evista, Mirena, Zometa, Reclast, Nuvaring, Primarin, Actonel), Application (Female Infertility, Postmenopausal Osteoporosis, Endometriosis, Contraception, PCOS, Menopause) - Global Forecast to 2024
5. DrugWatch: Mirena Lawsuit | Settlement Information & IUD Claims