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-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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	2
Patent Applications:	3,953
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

International Patents for LILETTA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112014000440
World Intellectual Property Organization (WIPO)	2013009674
European Patent Office	4378464	DISPOSITIF D'INSERTION D'IU (IUD INSERTION DEVICE)

Supplementary Protection Certificates for LILETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

LILETTA (Levonorgestrel) market dynamics and financial trajectory: exclusivity, competitive pressure, and revenue outlook

Last updated: June 1, 2026

LILETTA (levonorgestrel intrauterine system, IUS) is a long-acting, low-maintenance contraceptive that competes primarily against other levonorgestrel IUS brands (Mirena, Kyleena, Skyla) and the copper IUD category. Its commercial trajectory is shaped by U.S. formulary access, channel contracting with managed care, uptake tied to device-patient fit, and period-specific competitive price pressure as generics/biosimilars do not apply to IUS devices. Patent and regulatory milestones determine the durability of brand economics more than molecule competition.

What drives LILETTA market share in the US contraceptive IUD landscape?

LILETTA competes in the levonorgestrel IUD segment where prescriber selection is dominated by: (1) dose-and-duration match to patient age and bleeding goals, (2) conversion from counseling to insertion, (3) pharmacy-benefit vs medical-benefit coverage mechanics, and (4) clinic workflow and reimbursement.

Which comparators most affect LILETTA uptake?

• Mirena (levonorgestrel IUS): higher marketed duration/labeling, often positioned for longer-term use and certain bleeding profiles.
• Kyleena (levonorgestrel IUS): lower dose and typically shorter effective duration labeling than Mirena; frequently used for younger patients or when a smaller device is preferred.
• Skyla (levonorgestrel IUS): another lower-dose option with a shorter duration profile.
• Copper IUDs (non-hormonal): can win in patients seeking hormone-free contraception and in formulary contracting where non-hormonal devices are preferred.

How do payers and contracting influence LILETTA pricing power?

• Formulary placement: LILETTA’s ability to hold gross-to-net depends on national and regional managed care contracts.
• Channel split: revenue differs materially depending on whether LILETTA is reimbursed primarily through pharmacy benefit, medical benefit, or 340B programs for eligible clinics.
• Tendering and volume commitments: large contracting entities can drive short-cycle price concessions, reducing net revenue even if unit demand holds.

Where does demand elasticity show up most?

• Insertion behavior: the IUD is a one-time procedure with a high “switching cost” at the clinic level, which dampens churn for existing users.
• New-start volume: demand is more elastic when counseling patterns shift toward the lowest net-cost option on formulary.

How does LILETTA’s exclusivity timeline affect long-term financial performance?

For device-like drug products such as LILETTA, long-term financial performance tracks closely to patent term and secondary patent cliffs affecting formulation, manufacturing, and delivery/packaging-related IP. Unlike small-molecule pills, the “generic” concept is also constrained by device-specific regulatory and manufacturing requirements.

What exclusivity protections matter most for LILETTA?

• Orange Book drug product patents (composition, method-of-use, and device-delivery related claims where listed)
• Non-patent exclusivity (application-level exclusivity where applicable)
• Device and manufacturing control points that can act as de facto barriers even after some patent expiry

When do major exclusivity and patent events typically change pricing leverage?

Financial impact generally occurs around:

• Key patent expirations on listed Orange Book patents tied to the marketed product
• Launch of authorized or competing long-acting contraceptives via settlement or patent challenges (less common than for traditional pharma)

Because IUS products face fewer “true generics” than standard drugs, the most visible financial changes usually come from competitive brand pricing rather than direct generic substitution.

What patents protect LILETTA and how strong is the patent estate?

LILETTA’s patent landscape determines the degree to which competitors can launch adjacent IUS products or challenge claims tied to duration, implantation method, and drug-device structure.

How to evaluate patent strength for IUD brands

Patent strength in this category typically depends on:

• Number of Orange Book-listed patents and their remaining term
• Claim breadth (method-of-use vs composition vs manufacturing)
• Litigation posture (if any), including whether claims have been narrowed or settled
• Freedom-to-operate risk for any proposed substitution product

How many patents cover LILETTA?

A complete, defensible count requires an Orange Book pull that enumerates all listed patents for the marketed strength, dosage form, and route for LILETTA. Without that listing, a precise patent count and remaining-term distribution cannot be stated.

What is the Orange Book status of LILETTA and what does it imply for generic or competing IUS risk?

Orange Book status is the gating indicator for generic entry risk for drug products that have listed patents. For IUS products, the practical pathway still requires FDA approval for a substantially similar device and performance.

What does “listed patents” mean for market timing?

• If multiple patents remain active, any generic-like launch is constrained and often leads to design-arounds, licensing, or delayed approvals.
• If only narrow patents remain, competitive pressure may increase even if the molecule is unchanged.

When do generic entry risks rise for IUS products?

Generic-like risks rise when:

• Major method-of-use and product patents expire or are invalidated
• Manufacturing or device-specific patents are no longer enforceable
• Competitors can obtain approval without infringing remaining claims

A precise timeline cannot be produced without the Orange Book patent-by-patent expiration dates.

What patent litigation or Paragraph IV challenges affect LILETTA’s financial outlook?

Financial trajectory is most disrupted when litigated patent disputes force supply constraints, settlements that include delayed entry, or adverse rulings affecting exclusivity.

Has LILETTA faced major U.S. patent challenges?

A reliable litigation map requires docket-level case identification and settlement/public court record dates for LILETTA-related disputes. Without docket-specific sourcing, a factual litigation timeline cannot be provided.

How does LILETTA compare with Mirena, Kyleena, and Skyla on commercial positioning?

Key competitive dimensions

• Duration and label positioning: longer-duration brands can capture higher lifetime value per device start.
• Target populations: younger vs older cohorts, bleeding profile counseling, prior IUD use.
• Device size and patient comfort: smaller devices can win in fit-sensitive populations.
• Net price and rebates: payer-specific discounts and administered pricing drive selection at the point of prescribing.

What this means for revenue trajectory

In a fixed-size market of new contraceptive starts, unit share shifts between brands are the primary revenue driver once list price erosion takes hold. For IUS brands, price competition often results in:

• revenue declining slower than unit share if net pricing is stabilized by contracts, or
• revenue declining faster than unit share if payer concessions intensify.

Without time-series unit and net sales data, no quantified forecast can be stated.

What FDA and regulatory events influence LILETTA sales?

Regulatory levers that affect commercial performance

• Label expansions: additional indication durations, patient populations, or bleeding management claims
• Safety communications: any changes in prescribing guidance that impact utilization
• Manufacturing site changes: potential temporary supply impacts

A complete regulatory event timeline requires FDA label history and approval supplements specific to LILETTA.

How do manufacturing and supply dynamics impact LILETTA revenue?

For device-drug products, the economics can be sensitive to:

• raw material availability and controlled polymer components
• packaging line constraints
• inspection outcomes and quality releases
• distribution and inventory management at wholesalers and large clinics

What supply risks matter most for market share?

• Any constrained supply increases lost starts and can permanently shift formulary and prescriber habits in that region.

No production or recall events can be listed without sourced event records.

What do revenue and market dynamics look like over time for LILETTA?

A rigorous financial trajectory requires primary filings (company earnings releases, 10-K/10-Q segment notes, or audited sales disclosures) plus pharmacy and wholesaler reporting if available. Without sourced sales figures and period-by-period net sales, a numeric trajectory cannot be provided.

What can be said structurally about trajectory drivers

• Steady baseline from continued contraceptive demand and replacement cycles
• Revenue volatility from contracts (rebates, discounts, bundled purchasing)
• Competitive pricing effects from Mirena/Kyleena/Skyla and non-hormonal IUD alternatives
• IP-related durability that reduces classic generic pressure but not brand pricing competition

Key Takeaways

• LILETTA’s market performance is driven less by generic substitution risk and more by payer contracting, channel mechanics, and brand competition within levonorgestrel IUS products.
• Patent and Orange Book positioning matter for long-horizon protection, but financial swings most often reflect net pricing and formulary wins or losses rather than a sudden generic entry.
• A quantified financial trajectory and patent-based market timing framework requires enumerated Orange Book listings with expiration dates and sourced historical sales data; those elements are not provided here.

FAQs

1. How does LILETTA net pricing versus list price affect gross-to-net revenue for IUD brands?
2. What formulary tier do levonorgestrel IUS products typically occupy, and how does that change prescribing behavior?
3. What are the main clinical or device fit factors that shift patients between LILETTA, Mirena, and Kyleena?
4. How do FDA label expansions for contraceptive IUDs translate into unit demand and revenue?
5. What manufacturing or supply-chain events are most likely to disrupt IUS availability and lose new-start share?

References

No sources were cited because no specific Orange Book, FDA, litigation, or financial time-series data was provided in the prompt.

DrugChatter Q&A for LILETTA

Can Liletta be used for 8 years?