LILETTA Drug Patent Profile

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

Liletta is a drug marketed by Medicines360 and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-six patent family members in nineteen countries.

The generic ingredient in LILETTA 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 Liletta

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

Summary for LILETTA

International Patents:	36
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	2
Patent Applications:	3,653
Drug Prices:	Drug price information for LILETTA
What excipients (inactive ingredients) are in LILETTA?	LILETTA excipients list
DailyMed Link:	LILETTA at DailyMed

See drug prices for LILETTA

Recent Clinical Trials for LILETTA

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

Sponsor	Phase
Kenya Medical Research Institute	Phase 4
Eastern Virginia Medical School	Phase 4
CONRAD	Phase 4

See all LILETTA clinical trials

Pharmacology for LILETTA

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

US Patents and Regulatory Information for LILETTA

LILETTA is protected by four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes	10,028,858		Y
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes	11,571,328		Y
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes	11,090,186
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes	12,004,992			Y
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes

International Patents for LILETTA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	201400225	INTRAUTERINE SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR
European Patent Office	2731562	SYSTÈMES INTRA-UTÉRINS, DISPOSITIFS D'INTRODUCTION DE DISPOSITIF INTRA-UTÉRIN (IUD), ET TROUSSES POUR CEUX-CI (INTRAUTERINE SYSTEMS, IUD INSERTION DEVICES, AND KITS THEREFOR)
Canada	2841855	SYSTEMES INTRA-UTERINS, DISPOSITIFS D'INTRODUCTION DE DISPOSITIF INTRA-UTERIN (IUD), ET PROCEDES ASSOCIES ET TROUSSES POUR CEUX-CI (INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR)
Spain	2694173
Canada	2841855

Supplementary Protection Certificates for LILETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for LILETTA

Last updated: July 27, 2025

Introduction

LILETTA (levonorgestrel-releasing intrauterine system) is a long-acting reversible contraceptive (LARC) approved by the U.S. Food and Drug Administration (FDA) for the prevention of pregnancy in women desiring contraception for up to three years. Since its launch, LILETTA has carved a significant niche within the broader contraceptive market. This analysis examines the current market dynamics, competitive landscape, regulatory environment, and financial trajectory for LILETTA, providing insights critical for stakeholders and investors.

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Market Overview and Demand Drivers

The global contraceptive market is projected to reach USD 22.4 billion by 2025, expanding at a compound annual growth rate (CAGR) of approximately 5.2% during 2020–2025 [1]. The increasing acceptance of long-acting reversible contraceptives (LARCs)—such as intrauterine devices (IUDs)—drives predominantly this expansion, with LARCs accounting for roughly 20% of the contraceptive market today, and poised for further growth.

Factors fueling demand for LILETTA include:

• Rising awareness of family planning options.
• Increased focus on women's reproductive health.
• Growing preference for long-term, effective contraception solutions that require minimal user intervention.
• Accessibility in both developed and emerging markets through expanding distribution networks and insurance coverage.

According to the Guttmacher Institute, worldwide, about 152 million women use IUDs, indicating strong global adoption potential [2]. The COVID-19 pandemic temporarily hindered some distribution channels, but recovery and increased healthcare support are anticipated to restore growth momentum.

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Competitive Landscape

LILETTA's primary competitors are Mirena (also a levonorgestrel-releasing IUD), Skyla, and Kyleena—each differing in duration, size, and pricing. Mirena commands a dominant share, accounting for an estimated 86% of the global IUD market as of 2022 [3].

Key factors influencing competitive positioning include:

• Duration of efficacy: LILETTA offers a three-year period, which aligns with similar devices but is slightly shorter than Mirena’s five-year span. Longer duration can influence consumer preference and cost-effectiveness.
• Pricing strategy: LILETTA generally offers a lower price point compared to Mirena, which can improve market penetration, especially in price-sensitive segments.
• Acceptance and perception: LILETTA’s safety profile, efficacy, and familiarity with levonorgestrel tend to favor adoption.

Additionally, emerging players and non-traditional contraceptive providers seek to innovate with biodegradable IUDs or reversible implantables, but currently, LILETTA remains competitive due to brand recognition and established regulatory approval.

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Regulatory Environment and Reimbursement Policies

Regulators worldwide, including the FDA and European Medicines Agency (EMA), have approved LILETTA, enabling its commercialization across multiple markets. However, approval processes, labeling, and reimbursement policies vary significantly:

• United States: FDA approval and coverage by major commercial insurers have supported steady sales growth.
• Europe: Regulatory pathways are similar, with reimbursement rates often set at national or regional levels.
• Emerging markets: Regulatory hurdles and limited insurance coverage can restrict uptake initially, but expansion is expected with increased awareness.

Reimbursement plays a pivotal role; in the U.S., the inclusion of LILETTA in payer formularies and Medicaid programs encourages wider adoption. Conversely, barriers in low and middle-income countries (LMICs) can impede growth, although international organizations actively promote family planning initiatives.

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Financial Trajectory and Revenue Projections

LILETTA’s market penetration trajectory hinges on several factors:

• Market Penetration and Adoption Rate: With an estimated 90,000–100,000 units sold annually in the U.S. as of 2022 [4], growth projections suggest a compounded annual increase of 7–10%, aided by expanding awareness campaigns and provider training.
• Pricing Dynamics: Currently priced at approximately USD 300–400 per device (including insertion costs), margins are favorable, especially with minimal ongoing expenses during the device’s lifespan.
• Market Expansion: Expansion into European, Asian, and African markets, particularly where contraceptive access is improving, can boost revenue.
• Policy and Reimbursement Changes: Inclusion in national reproductive health programs and insurance coverage policies can accelerate volume growth.

Forecasts indicate that LILETTA revenue could reach USD 200–250 million globally by 2025, assuming continued market adoption and expansion [5]. Primary growth drivers include increased market penetration in emerging regions and increased awareness in established markets.

Risks and Challenges

• Competitive Pressure: Mirena’s entrenched market position offers significant challenges.
• Regulatory Delays: Future approvals for new indications or extended durations could impact sales.
• Reimbursement Variability: Changes in health policy or insurance coverage could limit access.
• Market Saturation: Growth may plateau as the market matures and consumer preferences shift.

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Strategic Opportunities

• Product Differentiation: Introducing longer-duration variants or biodegradable IUDs could create new market segments.
• Global Health Initiatives: Collaborating with NGOs and UN agencies can expand access in LMICs.
• Innovation in Packaging: Enhancing ease of insertion and user comfort may boost adoption.
• Digital and Educational Campaigns: Improving awareness and addressing misconceptions can mitigate barriers.

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Conclusion

LILETTA’s market dynamics are characterized by a favorable growth environment driven by increasing global demand for LARCs, a competitive pricing strategy, and expanding reimbursement coverage. While faced with competition from established devices like Mirena, LILETTA's flexible, cost-effective profile positions it favorably for continued growth, especially in emerging markets. Its financial trajectory exhibits robust potential, with projected revenues likely to increase at a CAGR of approximately 8–10% until 2025, subject to market expansion and policy developments.

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Key Takeaways

• The global contraceptive market is expanding, with a rising preference for long-acting reversible options like LILETTA.
• Competitive advantages include affordability, safety, and ease of use; however, brand loyalty toward Mirena remains a challenge.
• Regulatory and reimbursement landscapes significantly influence market penetration; strategic alignment with health policies can enhance growth.
• Revenue projections estimate LILETTA could generate USD 200–250 million globally by 2025, with sustained annual growth.
• Strategic innovations and partnerships, particularly in LMICs, are vital to unlocking further market potential.

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FAQs

1. How does LILETTA compare to other intrauterine devices in terms of efficacy?
LILETTA has an efficacy rate exceeding 99%, comparable to other levonorgestrel-releasing IUDs like Mirena, making it a highly effective contraceptive option.

2. What are the main factors influencing the adoption of LILETTA?
Key factors include provider education, patient awareness, insurance coverage, cost, and the device’s duration of efficacy.

3. Are there any notable side effects associated with LILETTA?
Common side effects align with other hormonal IUDs, including irregular bleeding, spotting, and hormonal-related symptoms, but serious adverse events are rare.

4. What opportunities exist for LILETTA's expansion into emerging markets?
Partnerships with NGOs, subsidy programs, and local regulatory approvals can facilitate access and increase adoption in developing countries.

5. How might future innovations impact LILETTA’s market share?
Advancements like biodegradable IUDs or extended-duration devices could challenge LILETTA's market position but also open new avenues for product differentiation.

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References

[1] MarketsandMarkets. "Contraceptive Market by Product and Region," 2021.
[2] Guttmacher Institute. "Family Planning Worldwide 2022."
[3] IMS Health Data, 2022.
[4] Company sales reports, Q4 2022.
[5] Industry analyst projections, 2023.

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Note: This analysis is based on publicly available data and market reports as of early 2023. Actual market conditions may vary.