KYLEENA Drug Patent Profile

When do Kyleena patents expire, and when can generic versions of Kyleena launch?

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

This drug has seventy-seven patent family members in thirty countries.

The generic ingredient in KYLEENA 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 Kyleena

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

Summary for KYLEENA

International Patents:	77
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	3
Patent Applications:	3,818
Drug Prices:	Drug price information for KYLEENA
What excipients (inactive ingredients) are in KYLEENA?	KYLEENA excipients list
DailyMed Link:	KYLEENA at DailyMed

See drug prices for KYLEENA

Recent Clinical Trials for KYLEENA

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

Sponsor	Phase
Arkansas Children's Hospital Research Institute	Phase 4
Science Valley Research Institute	Phase 2
Biós Farmacêutica	Phase 2

See all KYLEENA clinical trials

Pharmacology for KYLEENA

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

US Patents and Regulatory Information for KYLEENA

KYLEENA is protected by three 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	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes	11,850,182		Y
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes	10,561,524
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes	11,628,088		Y

Expired US Patents for KYLEENA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016	7,252,839

International Patents for KYLEENA

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20050340	A DELIVERY SYSTEM AND A MANUFACTURING PROCESS OF A DELIVERY SYSTEM
Japan	5390618
Norway	20051858

Supplementary Protection Certificates for KYLEENA

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: KYLEENA

Last updated: July 27, 2025

Introduction

KYLEENA, a progestin-releasing intrauterine device (IUD), has established itself as a significant player in the contraceptive market since its approval. As a long-acting reversible contraceptive (LARC), KYLEENA offers a contraceptive option for women seeking highly effective, maintenance-free birth control. The following analysis examines the current market landscape, key drivers shaping its financial trajectory, regulatory landscape, competitive environment, and future growth opportunities.

Market Overview

The global contraceptive market, valued at approximately USD 20 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2030 ([1]). Within this broad landscape, LARCs—including intrauterine devices (IUDs) like KYLEENA—are gaining favor due to high efficacy, minimal user intervention, and favorable safety profiles. KYLEENA, specifically, has carved out a niche among hormonal IUDs for women seeking a five-year, hormone-releasing contraceptive option.

Market Dynamics

Increasing Adoption of LARCs

The rising awareness of reversible long-term contraception has driven the demand for IUDs. According to the Centers for Disease Control and Prevention (CDC), the use of IUDs increased nearly fivefold from 2002 to 2017 among women aged 15-44 ([2]). This trend is fueled by evidence of safety, cost-effectiveness over time, and minimal maintenance requirements. KYLEENA’s five-year lifespan aligns with these preferences, providing a reliable option that obviates the need for daily compliance.

Evolving Consumer Preferences

The modern consumer favors contraceptive methods that are discreet, effective, and require minimal intervention. KYLEENA addresses these preferences by offering a hormone-releasing device that reduces menstrual bleeding in many users, improving user satisfaction. Additionally, growing autonomy and informed choices among women contribute to increasing uptake, especially in developed markets.

Regulatory and Reimbursement Landscape

Regulatory approvals across various regions have bolstered KYLEENA’s market penetration. Approved by the U.S. Food and Drug Administration (FDA) in 2009 and by the European Medicines Agency (EMA) shortly thereafter, KYLEENA’s registration status facilitates access. Reimbursement policies, especially in North America and Europe, support affordability, further incentivizing usage. However, reimbursement disparities in emerging markets pose a challenge to maximizing sales potential ([3]).

Competitive Landscape

The contraceptive IUD market is dominated by a few key players: Bayer (Mirena), Pfizer (Liletta), Teva (Skyla), and local manufacturers. KYLEENA's differentiation includes its five-year duration and specific hormone release profile. However, competitors often engage in aggressive pricing, marketing, and product innovations—factors influencing KYLEENA’s market share. Moreover, non-hormonal copper IUDs like Paragard provide alternative options, shifting consumer choices within the LARC sphere.

Price Sensitivity and Market Penetration

The pricing of KYLEENA, influenced by manufacturing costs, reimbursement policies, and competitive pressure, directly impacts adoption rates. In regions with health insurance coverage, high costs are less prohibitive, but in markets where out-of-pocket payments are significant, price sensitivity hampers growth. Strategic pricing and patient assistance programs are critical to expanding penetration.

Financial Trajectory

Revenue Generation and Growth Drivers

KYLEENA's revenue trajectory hinges on several factors:

• Market Penetration: Expansion into urban and peri-urban markets, alongside increased physician awareness, drives sales volume.

• Geographic Expansion: Entry into emerging markets like Latin America, Southeast Asia, and Africa, where contraceptive needs are expanding, offers significant upside. Localization efforts and partnerships with governments and NGOs facilitate such entry.

• Regulatory Approvals: Securing approvals for broader indications and in additional countries accelerates revenue streams.

• Innovative Features: Emphasizing unique aspects—such as reduced menstrual bleeding—enhances consumer appeal, fostering brand loyalty and repeat prescriptions.

Impact of Competitive Dynamics on Financials

Market share erosion due to aggressive competition impacts revenue forecasts, necessitating continuous marketing investments and product differentiation. Patent expirations or challenges could influence pricing power, while potential new formulations might threaten existing revenue streams.

Cost Structure and Profitability

Manufacturing economies of scale and streamlined supply chains are vital for maintaining profitability. Regulatory compliance costs, clinical trial expenses for expanding indications, and marketing expenditures form significant components of the overall cost structure.

Future Growth Projections

Analysts project KYLEENA’s global revenues to grow at a CAGR of 4-6% over the next five years, driven by increased adoption, expanded indications, and geographic diversification ([4]). Its market share is expected to rise modestly, contingent upon competitors’ strategies, pricing policies, and regulatory landscape.

Regulatory and Market Risks

• Regulatory Uncertainty: Regulations governing contraceptive devices can evolve, impacting approval timelines and market access.

• Reimbursement Policies: Funding cuts or policy shifts impacting insurance coverage can reduce user affordability.

• Safety and Litigation Risks: Adverse event reports or legal challenges can tarnish brand reputation and affect sales.

• Market Saturation: In mature markets, growth may plateau unless new features or device enhancements are introduced.

Future Opportunities

• Product Line Extensions: Development of next-generation IUDs with longer durations or reduced side effects.

• Digital Health Integration: Incorporating app-based reminders or tracking to enhance user engagement.

• Strategic Partnerships: Collaborations with healthcare providers and governments to promote distribution.

• Targeted Marketing: Focused campaigns in emerging markets to expand awareness and acceptance.

Conclusion

KYLEENA's market dynamics epitomize the broader trends in the contraceptive segment: a shift towards long-acting, user-friendly methods driven by increased awareness, technological innovation, and evolving consumer preferences. Its financial trajectory is expected to be positive but remains sensitive to competitive pressures, regulatory changes, and reimbursement policies. Strategic positioning, ongoing innovation, and geographic expansion are essential to capitalize on the growing demand for effective, hormone-releasing IUDs.

Key Takeaways

• The global contraceptive market, especially LARCs, is expanding at a CAGR of 6%, with KYLEENA positioned as a premium, long-duration hormonal IUD.

• Increasing adoption, regulatory support, and favorable reimbursement policies underpin sustained revenue growth prospects.

• Competition from other branded IUDs and copper alternatives necessitates clear differentiation and pricing strategies.

• Emerging markets present significant growth opportunities, contingent upon effective market entry and awareness campaigns.

• Continuous innovation, strategic partnerships, and tailored marketing are critical to achieve and maintain market share and financial growth.

FAQs

Q1: What distinguishes KYLEENA from other hormonal IUDs?
A: KYLEENA offers a five-year contraceptive duration, approved for reducing menstrual bleeding in some users, and has a specific progestin release profile. Its safety and efficacy profile make it a preferred choice for women seeking long-term contraception with fewer side effects.

Q2: What are the primary challenges impacting KYLEENA’s market growth?
A: Challenges include competitive pricing pressures, regulatory hurdles in certain regions, reimbursement disparities, and market saturation in developed countries.

Q3: How does regulatory approval influence KYLEENA’s financial performance?
A: Regulatory approvals enable market access, bolstering sales volumes and revenue. Delays or restrictions can hamper growth, while newer approvals facilitate geographic expansion.

Q4: In which regions is KYLEENA experiencing the fastest growth?
A: Currently, North America and Europe exhibit steady growth due to established healthcare infrastructure. Emerging markets in Asia, Latin America, and Africa present high-growth potential, driven by increasing awareness and demand.

Q5: What strategic actions can companies take to enhance KYLEENA’s market share?
A: Companies should focus on targeted marketing, expanding reimbursement frameworks, pursuing innovational device enhancements, building healthcare provider awareness, and entering underserved markets through strategic partnerships.

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References

[1] MarketWatch, "Global Contraceptive Market Size & Trends," 2022.
[2] CDC, "Contraceptive Use in the United States," 2017.
[3] IMS Health, "Reimbursement Policies and Contraceptive Market," 2021.
[4] MarketResearch.com, "Future Outlook for Hormonal IUDs," 2023.