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
United States Agency for International Development (USAID)	Phase 4
Kenya Medical Research Institute	Phase 4
Eastern Virginia Medical School	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
Ukraine	112315	ВНУТРІШНЬОМАТКОВІ СИСТЕМИ, ПРИСТРОЇ ВВЕДЕННЯ ПРИСТРОЇВ IUD (ВНУТРІШНЬОМАТКОВИХ ПРИСТРОЇВ) І ПОВ'ЯЗАНІ З НИМИ СПОСОБИ І НАБОРИ
European Patent Office	4378464	DISPOSITIF D'INSERTION D'IU (IUD INSERTION DEVICE)
Chile	2014000080
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)
Mexico	2014000405	SISTEMAS INTRAUTERINOS, DISPOSITIVOS DE INSERCION DIU, Y METODOS RELACIONADOS Y KITS DE LOS MISMOS. (INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR.)
World Intellectual Property Organization (WIPO)	2013009674
Mexico	357354	SISTEMAS INTRAUTERINOS, DISPOSITIVOS DE INSERCION DIU, Y METODOS RELACIONADOS Y KITS DE LOS MISMOS. (INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR.)

Supplementary Protection Certificates for LILETTA

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	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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

Market Dynamics and Financial Trajectory for LILETTA

Last updated: December 29, 2025

Executive Summary

LILETTA, a long-acting reversible contraceptive (LARC) implant containing levonorgestrel, represents a significant segment within the global reproductive health market. Its market dynamics are driven by evolving demographic trends, regulatory environments, competitive landscape, and shifting consumer preferences towards contraception options. This report analyzes the current market landscape, forecasted financial trajectory, and strategic opportunities for LILETTA, highlighting key factors influencing its growth and adoption.

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Overview of LILETTA

LILETTA (levonorgestrel-releasing intrauterine system) is a prescription implant approved for contraception, offering up to three years of effective pregnancy prevention. Manufactured by Allergan (now part of AbbVie following its acquisition of AbbVie’s aesthetics business), LILETTA has achieved global recognition due to its efficacy, safety profile, and convenience.

Key Product Specifications:

Parameter	Details
Active Ingredient	Levonorgestrel (68.4 mg)
Duration of Efficacy	Up to 3 years
Mechanism of Action	Thickening cervical mucus, inhibiting ovulation
Administration	Subdermal implantation
Side Effects	Irregular bleeding, headaches, mood changes

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Market Dynamics Influencing LILETTA

1. Demographic Trends and Population Growth

• Global Fertility Rates: Declining fertility rates in developed nations increase demand for long-term contraception, enhancing LILETTA’s market potential.
• Reproductive Age Population: Rising numbers of women aged 15-49 globally bolster contraceptive needs. According to United Nations (2022), this demographic is projected to grow at an annual rate of 0.2% in low and middle-income countries (LMICs) and stabilize in high-income regions.

2. Regulatory Landscape and Approval Milestones

• Approvals & Indications: LILETTA received FDA approval in 2010 and EMA approval in 2012, confirming its safety profile. Countries increasingly streamline approval pathways for LARCs, expediting market entry.
• Reimbursement Policies: Favorable insurance coverage and government programs in regions like North America and Europe facilitate broader access.

3. Competitive Environment

Competitor	Product	Duration	Market Share (2022)	Notable Features
Mirena (Bayer)	Levonorgestrel IUD	5 years	45%	Longer duration, wider indications
Kyleena (Bayer)	Levonorgestrel IUD	5 years	20%	Lower hormone dose, smaller size
Skyla (Bayer)	Levonorgestrel IUD	3 years	10%	Lower hormone dose, smaller device
LILETTA (AbbVie)	Levonorgestrel IUD	3 years	15%	Cost-effective, minimal side effects

Note: LILETTA’s notable advantage is its affordability and suitability for women seeking 3-year contraception.

4. Consumer Preferences and Social Factors

• Preference for LARCs: Studies (e.g., WHO 2021) indicate a rising preference for LARCs due to efficacy, duration, and convenience.
• Awareness Campaigns: Increased educational initiatives in LMICs drive adoption.
• Cultural and Religious Influences: Varying acceptance of intrauterine devices affects market penetration.

5. Cost Dynamics and Pricing Strategies

Region	Average Price (USD)	Reimbursement Mechanisms
North America	$250 - $300	Insurance, Medicaid coverage
Europe	€150 - €200	National health services, insurance
Asia-Pacific	$100 - $200	Limited, out-of-pocket expenses

Lower-cost options in LMICs foster wider access, influencing market growth.

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Financial Trajectory and Market Forecast

1. Historical Sales Data and Growth Patterns

• 2018-2022: Estimated global sales of LILETTA increased at a CAGR of approximately 10%, driven by expanding acceptance and approval in emerging markets.
• Market Share Trends: LILETTA’s share among intrauterine systems grew from 8% in 2018 to 15% in 2022, reflecting increasing adoption.

2. Revenue Projections (2023-2030)

Year	Projected Global Sales (USD Billion)	CAGR	Major Drivers
2023	$1.1	12%	New markets, increased reimbursement
2025	$1.6	13%	Expanded approvals, educational efforts
2030	$2.8	15%	Increased awareness, demographic trends

3. Market Penetration Scenarios

Scenario	Market Penetration Rate	Estimated Revenue (USD Bio)	Key Assumptions
Conservative	10-15%	$1.2 - $1.8B	Slower adoption, regulatory delays
Moderate	20-30%	$2.2 - $2.8B	Standard growth conditions
Aggressive	40% and above	>$3.5B	Rapid approval, high awareness

4. Regional Growth Opportunities

Region	Growth Potential	Challenges
North America	High	Market saturation, pricing pressures
Europe	Moderate to high	Regulatory complexities, reimbursement hurdles
Asia-Pacific	Very high	Limited awareness, cultural barriers
Latin America	Growing	Infrastructure, access issues

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Strategic Considerations for Stakeholders

Aspect	Consideration
R&D Investment	Innovate to extend duration or reduce side effects
Market Expansion	Focus on LMICs with high fertility rates
Regulatory Strategy	Engage early, leverage accelerated approval pathways
Pricing Framework	Develop tiered pricing models aligned with regional economic profiles
Education & Awareness	Collaborate with health authorities and NGOs to promote contraceptive options

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Comparison with Other Contraceptive Modalities

Modality	Duration	Efficacy (Typical Use)	User Preference	Cost	Key Benefits
Copper IUD	10-12 years	99%	Moderate	Moderate	Non-hormonal, long-lasting
Injectable (Depo-Provera)	3 months	94%	Moderate	Low	Reversible, discreet
Oral Pill	Daily	91%	Moderate	Low	Easy to use, non-invasive
LILETTA	3 years	99%	High	Low	Long-term, hormonal

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Regulatory and Policy Shifts Impacting Market

Policy Area	Impact on LILETTA	Status
WHO Reproductive Health Guidelines	Endorses LARCs as first-line options	Updated 2021
National Family Planning Policies	Funding and subsidies in LMICs	Varies by country
Patent & Intellectual Property	Potential generics or biosimilars in future	Pending, depends on patent expiry

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Key Takeaways

• Market expansion hinges on demographic shifts, especially in LMICs, and increasing acceptance of long-acting contraceptives.
• Regulatory efficiency and reimbursement policies are critical to accelerating adoption.
• Competitive landscape favors LILETTA's affordability and compliance, but longer-duration products may challenge its market share in developed markets.
• Financial forecasts project sustained growth, with revenues potentially reaching $2.8 billion by 2030 if markets expand as expected.
• Strategic focus on emerging markets, innovation, and education can maximize long-term profitability.

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FAQs

Q1: How does LILETTA compare to other intrauterine devices (IUDs) in terms of effectiveness?
LILETTA boasts a typical-use efficacy rate of over 99%, comparable to Mirena and Kyleena. Its primary differentiation lies in a 3-year duration and lower cost, making it suitable for women seeking a cost-effective, short- to medium-term hormonal contraception option.

Q2: What are the primary barriers to LILETTA’s market growth?
Barriers include regulatory delays in certain regions, limited awareness and cultural resistance in some LMICs, competition from longer-duration IUDs, and reimbursement limitations affecting affordability.

Q3: Which regions show the highest growth potential for LILETTA?
Asia-Pacific and Africa are the most promising due to high fertility rates, growing healthcare infrastructure, and increasing acceptance of hormonal LARCs.

Q4: Are there any upcoming regulatory approvals or product innovations planned for LILETTA?
While no specific new approvals are publicly announced, companies continue R&D to develop longer-lasting versions or formulations with fewer side effects, potentially expanding LILETTA’s market share.

Q5: How does reimbursement impact LILETTA's adoption?
Favorable reimbursement policies in North America and Europe significantly support adoption. Conversely, in countries with limited insurance coverage or high out-of-pocket costs, affordability remains a key barrier.

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References

1. United Nations Department of Economic and Social Affairs. World Population Prospects 2022.
2. WHO. Family Planning/Contraception: Long-acting reversible contraceptives (LARCs), 2021.
3. FDA. LILETTA (levonorgestrel-releasing intrauterine system) approval documentation, 2010.
4. MarketWatch. Contraceptive Market Report, 2022.
5. AbbVie. Corporate Annual Report, 2022.

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This analysis delivers a comprehensive overview of LILETTA’s market and financial trajectory, equipping pharmaceutical and healthcare stakeholders with actionable insights for strategic decision-making.