LILETTA Drug Patent Profile

When do Liletta patents expire, 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-six 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

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			Y
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes			Y
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes				Y

International Patents for LILETTA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012282832
Australia	2015221468
Brazil	112014000440
Brazil	122015016218

Supplementary Protection Certificates for LILETTA

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	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	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

Investment Scenario and Fundamentals Analysis for LILETTA

Last updated: February 20, 2026

LILETTA (levonorgestrel-releasing intrauterine system) is a contraceptive device marketed by Bayer. It is positioned within the reproductive health segment, targeting women seeking long-term contraception. Its market performance depends on regulatory approvals, manufacturing capacity, competitive dynamics, and adoption trends.

Market Overview

LILETTA operates in the global contraception market, valued at approximately USD 20 billion in 2022, with a compound annual growth rate (CAGR) of 4.8% projected through 2027.[1] The intrauterine device (IUD) segment accounts for roughly 35% of this market, with a rising preference for long-acting reversible contraceptives (LARCs), driven by efficacy and convenience.

Product Positioning & Regulatory Status

• Marketed Since: 2013 (U.S.), 2015 (Europe)
• Regulatory Approvals: FDA (2013), EMA (2015), multiple Asian and Middle Eastern approvals
• Key Competitors: Mirena (Bayer), Skyla (Allergan), Jaydess (Bayer), and newer generics

Financial & Commercial Fundamentals

Revenue and Market Share

• Estimated global sales of LILETTA are USD 300-400 million annually, with Bayer holding approximately 65% of the intrauterine contraception market in North America.
• The product benefits from high continuation rates (~90%) and monthly efficacy.

Pricing & Reimbursement

• Average selling price (ASP): USD 250–USD 350 per unit
• Reimbursement varies globally; high in the U.S., moderate in Europe, variable in emerging markets

Manufacturing & Supply Chain

• Bayer’s manufacturing capabilities mitigate supply disruptions
• Sterilization and quality control certifications align with international standards

Patent & Exclusivity

• Patent protections last until 2026 in key jurisdictions
• No current patent litigations specific to LILETTA

Clinical & Safety Data

• Demonstrates over 99% efficacy in preventing pregnancy
• Designed for 3-year use; secondary indications include treatment of heavy menstrual bleeding

Growth Drivers & Risks

Drivers

• Rising contraceptive awareness and acceptance
• Increased reimbursement coverage
• Expansion into emerging markets

Risks

• Competition from generics approaching patent expiry
• Regulatory delays or restrictions
• Rising concerns about hormonal side effects influencing consumer preference

Investment Considerations

• Bayer’s contraception portfolio's strength positions LILETTA as a key asset
• Patent expiry in 2026 indicates potential revenue erosion post-expiry unless new formulations or indications are developed
• The segment’s growth correlates with women’s health focus and societal acceptance

Strategic Actions for Enhancement

• Accelerate pipeline development for next-generation intrauterine systems
• Expand into emerging markets with tailored marketing strategies
• Explore additional indications, such as heavy menstrual bleeding or endometriosis

Conclusion

LILETTA's fundamentals show steady revenue streams driven by its long-term market position. Near-term risks include patent expiration and increasing competition; however, opportunities exist via market expansion and pipeline innovation. For investors, monitoring Bayer's pipeline, market expansion strategies, and competitive landscape remains critical.

Key Takeaways

• LILETTA is a leading intrauterine contraceptive with stable revenues
• Patent protection lasts until 2026, after which generic entrants may challenge market share
• Growth hinges on market expansion, especially in emerging regions
• Competitive landscape is intensifying with generic entrants from 2026 onward
• Pipeline development and indication expansion present future upside

FAQs

1. When does LILETTA’s patent expire?
In most jurisdictions, patent expiry is scheduled for 2026, opening the market to generics.

2. How does LILETTA’s efficacy compare to competitors?
It has over 99% efficacy, comparable to other hormonal IUDs like Mirena.

3. What are the main risks affecting LILETTA’s future sales?
Patent expiration, increased competition from generics, regulatory changes, and consumer concerns about hormonal side effects.

4. Are there new indications for LILETTA being developed?
Yes, additional approved indications include treatment for heavy menstrual bleeding, broadening its therapeutic profile.

5. How significant is Bayer's market share in intrauterine contraceptive devices?
Bayer holds approximately 65% of the North American intrauterine device market, reflecting robust market penetration.

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References

[1] Allied Market Research. (2022). Contraceptive Devices Market Forecast.