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 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:	104
Clinical Trials:	2
Patent Applications:	4,719
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			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
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
Canada	3099636
China	116999234
Eurasian Patent Organization	201490251	ВНУТРИМАТОЧНЫЕ СИСТЕМЫ, УСТРОЙСТВА ВВЕДЕНИЯ УСТРОЙСТВ IUD (ВНУТРИМАТОЧНЫХ УСТРОЙСТВ) И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И НАБОРЫ
Japan	2021518216
Spain	2980154

Supplementary Protection Certificates for LILETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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	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

Introduction

LILETTA, a levonorgestrel-releasing intrauterine system (IUS), has been a significant player in the contraceptive market since its initial approval in 2015. Developed by Medicines360, a nonprofit organization, and partnered with Allergan (now part of AbbVie), LILETTA has undergone several key developments that have impacted its market dynamics and financial trajectory.

Approval and Expansion of Use

LILETTA was initially approved by the FDA in February 2015 for the prevention of pregnancy for up to three years. However, subsequent clinical trials, including the large-scale ACCESS IUS study, led to the FDA extending its approved duration of use to up to six years in 2019, and later to up to eight years[1][2][4].

Clinical Efficacy and Safety

The ACCESS IUS trial, which involved 1,751 U.S. women, demonstrated that LILETTA is more than 99% effective in preventing pregnancy over its approved duration. This high efficacy rate, combined with its extended use period, has made LILETTA a preferred option for many women seeking long-term contraception[1].

Market Impact

The approval of LILETTA for an extended duration has significantly impacted the market for hormonal IUDs. Prior to LILETTA's entry, Bayer’s Mirena device was the dominant player, approved for only five years of use. LILETTA’s longer approved duration and lower cost have forced competitors to adjust their pricing and product offerings. For instance, Bayer’s Mirena device also saw an extension of its approved use to eight years, largely due to the competitive pressure from LILETTA[4].

Pricing Strategy

Medicines360’s mission to provide affordable healthcare has been a cornerstone of LILETTA’s market strategy. Despite the challenges posed by the tax code, FDA regulations, and supply chain intermediaries, LILETTA remains available at a lower cost compared to other hormonal IUDs. The device is particularly attractive to public health clinics enrolled in the 340B Drug Pricing Program, where it is available at a reduced cost[1][4].

Financial Performance

Since its launch, LILETTA has achieved significant financial milestones. Over 435,000 units have been sold in the U.S. at a low price, saving the healthcare system approximately $100 million. Initially priced at $50, Medicines360 adjusted the price to $100 after conducting market research and considering its costs. This pricing strategy has helped maintain affordability while ensuring the sustainability of the product[4].

Supply Chain and Distribution

The supply chain for LILETTA involves multiple intermediaries, including wholesalers who charge fees based on the list price of the device. Despite these challenges, Medicines360’s unique mission-driven model has enabled the device to reach a broader population, particularly in public health clinics. The partnership with Allergan has also enhanced manufacturing and distribution capabilities[1][4].

Global Reach

Beyond the U.S., LILETTA is also making an impact globally. In Nigeria, for example, it is marketed under the trade name AVIBELA and is priced between $12 to $16 per unit for public sector distributors. This affordable pricing has made it a viable option for family planning programs in low-resource settings[5].

Competitive Landscape

LILETTA’s entry into the market has not only expanded the options for women but also influenced the competitive landscape. Other manufacturers, such as Bayer, have had to adapt to the new market dynamics. The competition has led to better pricing and extended durations of use for other hormonal IUDs, ultimately benefiting consumers[4].

Regulatory and Nonprofit Challenges

Medicines360 has faced several challenges, including those related to the tax code, FDA regulations, and Medicare and Medicaid reimbursement. However, the organization’s commitment to providing affordable healthcare has helped navigate these obstacles. The success of LILETTA underscores the potential of nonprofit pharmaceutical models in addressing public health needs[3][4].

Impact on Public Health

The broader use of LILETTA has had a positive impact on public health. By providing an effective, long-term contraceptive option at a lower cost, LILETTA has helped reduce unintended pregnancies and associated healthcare costs. This aligns with Medicines360’s mission to expand women’s access to quality medicines[1][4].

Future Outlook

As LILETTA continues to be a leading option in the contraceptive market, its future outlook is promising. With ongoing investments in product development and distribution, Medicines360 and its partners are likely to maintain their competitive edge. The extended duration of use and affordable pricing will continue to make LILETTA an attractive choice for women and healthcare providers alike.

Key Takeaways

• Extended Approval: LILETTA is approved for up to eight years of pregnancy prevention.
• High Efficacy: More than 99% effective in preventing pregnancy.
• Affordable Pricing: Available at a lower cost compared to other hormonal IUDs.
• Market Impact: Forced competitors to adjust pricing and product offerings.
• Global Reach: Available in low-resource settings under different trade names.
• Nonprofit Model: Demonstrates the effectiveness of nonprofit pharmaceutical models in addressing public health needs.

FAQs

What is LILETTA and how does it work?

LILETTA is a levonorgestrel-releasing intrauterine system (IUS) placed in the uterus to prevent pregnancy for up to eight years. It releases a hormone that prevents ovulation and thickens cervical mucus to prevent sperm from reaching the egg.

How effective is LILETTA in preventing pregnancy?

LILETTA is more than 99% effective in preventing pregnancy over its approved duration.

What are the key benefits of LILETTA compared to other hormonal IUDs?

LILETTA offers an extended duration of use (up to eight years), high efficacy, and is available at a lower cost compared to other hormonal IUDs.

How has LILETTA impacted the market for hormonal IUDs?

LILETTA’s entry and extended approval have forced competitors to adjust their pricing and product offerings, leading to better options for consumers.

Is LILETTA available globally?

Yes, LILETTA is available globally under different trade names, such as AVIBELA in Nigeria, and is priced affordably for public sector distributors.

Sources

1. FDA Approves Medicines360's LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years. Medicines360.
2. LILETTA (levonorgestrel-releasing intrauterine system). FDA.
3. ASPE Report Nonprofit Pharma. ASPE.
4. A Nonprofit's Expensive Road to Inexpensive Birth Control. Philanthropy.com.
5. Provision of the levonorgestrel intrauterine system in Nigeria. Gates Open Research.