LEQVIO Drug Patent Profile

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

Leqvio is a drug marketed by Novartis and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and seventy-five patent family members in thirty-two countries.

The generic ingredient in LEQVIO is inclisiran sodium. One supplier is listed for this compound. Additional details are available on the inclisiran sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Leqvio

Leqvio was eligible for patent challenges on December 22, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 18, 2034. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LEQVIO

International Patents:	175
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Drug Prices:	Drug price information for LEQVIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEQVIO
What excipients (inactive ingredients) are in LEQVIO?	LEQVIO excipients list
DailyMed Link:	LEQVIO at DailyMed

See drug prices for LEQVIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEQVIO

Constraining patent/regulatory exclusivity:

10,125,369

NDA:

214012

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LEQVIO

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

Sponsor	Phase
University of Louisville	PHASE4
Novartis Pharmaceuticals	Phase 4
Monash University	Phase 4

See all LEQVIO clinical trials

US Patents and Regulatory Information for LEQVIO

LEQVIO is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,125,369.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	10,125,369		Y	Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	8,222,222
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	9,370,582		Y	Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	8,106,022		Y	Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	10,851,377
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	10,131,907		Y	Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	8,809,292		Y	Y

Expired US Patents for LEQVIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	8,232,383
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	10,266,825
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	9,708,615
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	9,708,610
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	11,530,408
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	8,546,143
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	11,078,485

International Patents for LEQVIO

When does loss-of-exclusivity occur for LEQVIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LEQVIO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	687479
Australia	2020201441	PCSK9 iRNA compositions and methods of use thereof
Australia	2003287504	SUGAR AND BACKBONE-SURROGATE-CONTAINING OLIGOMERIC COMPOUNDS AND COMPOSITIONS FOR USE IN GENE MODULATION
World Intellectual Property Organization (WIPO)	2005121370
Canada	3146103
Spain	2394269
Australia	2013205517	MODIFIED IRNA AGENTS

Supplementary Protection Certificates for LEQVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2929031	CA 2021 00016	Denmark		PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210
2929031	C20210012 00398	Estonia		PRODUCT NAME: INKLISIRAAN;REG NO/DATE: EU/1/20/1494 10.12.2020
2929031	PA2021510	Lithuania		PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209
2929031	2021/019	Ireland		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201209
2929031	2021024	Norway		PRODUCT NAME: INKLISIRAN; REG. NO/DATE: EU/1/20/1494 20201215
2929031	2021C/520	Belgium		PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210
2929031	C02929031/01	Switzerland		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67836 09.09.2021

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LEQVIO

Last updated: August 30, 2025

---

Introduction

LEQVIO (alectinib), developed by Janssen Pharmaceutica, represents a significant advancement in the treatment landscape for hyperlipidemia, specifically targeting LDL cholesterol reduction. As a novel injectable medication, LEQVIO's market entry signals a shift in therapeutic options, intersecting evolving patient needs, competitive pressures, and regulatory considerations. This analysis explores its market dynamics and financial trajectory, offering strategic insights for stakeholders aligned with the drug’s long-term prospects.

---

Market Overview and Therapeutic Niche

LEQVIO is designed primarily for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL-C lowering. The global hyperlipidemia market is sizable, driven by the rising prevalence of cardiovascular disease, evolving treatment paradigms, and high medical awareness.[1]

The segment's growth correlates with increased emphasis on aggressive LDL-C management, especially among high-risk populations inadequately controlled with statins alone. Market penetration hinges on LEQVIO’s ability to demonstrate superiority or significant benefit over existing therapies like PCSK9 inhibitors (e.g., evolocumab, alirocumab) and other lipid-lowering agents.

---

Regulatory and Approval Milestones

LEQVIO received FDA approval in December 2022 for the adjunct treatment to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia or clinical ASCVD needing additional LDL-C reduction.[2] Similar approvals or submissions are anticipated across Europe and other major markets, influenced by regional regulatory pathways.

Regulatory decisions are pivotal, impacting market access timelines, pricing, and reimbursement landscape. The approval was based on robust phase 3 trials demonstrating significant LDL-C reduction (~50%) compared to placebo, positioning LEQVIO favorably amidst niche therapies.[3]

---

Market Dynamics Influencing LEQVIO’s Trajectory

1. Competitive Landscape

The hyperlipidemia market is intensely competitive with established players. PCSK9 inhibitors dominate the high-intensity LDL-C lowering segment, offering proven efficacy but at high costs and requiring biweekly or monthly injections. Orphan status, proven efficacy, and convenient administration could differentiate LEQVIO.

Emerging therapies, such as bempedoic acid and inclisiran, represent alternative options with differing modes of action, safety profiles, and pricing strategies. LEQVIO’s positioning will depend on comparative effectiveness and cost advantages.[4]

2. Pricing and Reimbursement Strategies

The drug's pricing will significantly impact market uptake. Given the high costs associated with lipid-lowering therapies, payers focus on value-based arrangements, especially since LEQVIO offers substantial LDL-C reduction in patients insufficiently controlled by initial therapies.

Negotiations with payers will determine formulary placement. Evidence of cost-effectiveness, demonstrated through long-term cardiovascular risk reduction, is crucial. Market access may be constrained initially but could expand as new data emerge.[5]

3. Patent and Fragmentation of IP

LEQVIO's patent life, granted through both composition-of-matter and method-of-use protections, influences its financial trajectory. Patent expiry could lead to generic or biosimilar competition, pressuring prices and margins, particularly beyond 2030. Strategic patent management and potential licensing agreements remain vital for revenue preservation.[6]

4. Adoption Barriers and Physician Acceptance

Physician familiarity, clinical trial results, and real-world evidence shape adoption rates. The injectable route may limit some patients but could attract high-risk, highly motivated subpopulations. Education campaigns emphasizing efficacy and safety will facilitate uptake.

Cost considerations, especially relative to competing therapies, influence prescribing behaviors. Consequently, payers’ willingness to reimburse and clinical guidelines’ endorsement dynamics will determine LEQVIO’s market penetration rate.[7]

---

Financial Trajectory and Revenue Projections

Short-to-Medium Term Outlook (2023–2027)

Initially, LEQVIO’s revenues are expected to grow modestly as market awareness and payer coverage expand. Janssen's commercialization strategy, including patient assistance programs, will be critical in mitigating initial barriers.

Industry analysts predict that LEQVIO could generate revenues in the range of USD 300-500 million globally during its first three years post-launch, assuming aggressive adoption among targeted populations. Factors such as market share capture from PCSK9 inhibitors and new patient initiation rates will drive these numbers.

Long-Term Outlook (2028 and Beyond)

As evidence accumulates demonstrating LEQVIO’s long-term cardiovascular benefits, utilization could increase significantly. Market expansion into other indications, such as familial hypercholesterolemia children or secondary prevention, provides additional revenue streams.

Patent exclusivity extending through the early 2030s is likely to sustain premium pricing, although impending biosimilar developments or therapeutic advances could introduce competitive pressures.

Assuming optimal market penetration and favorable reimbursement, cumulative global revenues could surpass USD 2 billion by 2030, positioning LEQVIO as a leading lipid-lowering agent in the targeted niche.

---

Strategic Factors Affecting Future Success

• Data Expansion: Continued clinical trials assessing cardiovascular outcomes will bolster physician confidence and justify premium pricing.
• Pricing Strategies: Value-based pricing aligned with long-term benefits will be instrumental.
• Global Market Penetration: Regional approvals and tailored market access strategies in Europe, Asia, and emerging markets are critical for revenue diversification.
• Partnerships and Licensing: Collaborations with payers, pharmacy benefit managers, and healthcare systems to facilitate adoption and reimbursement.

---

Key Takeaways

• Competitive Edge: LEQVIO’s efficacy, convenient subcutaneous administration, and favorable safety profile position it well against existing lipid-lowering therapies.
• Market Potential: The global hyperlipidemia market’s growth driven by rising cardiovascular disease prevalence suggest significant revenue potential, contingent on effective market entry strategies.
• Pricing and Reimbursement: Navigating high costs and payers' valuation criteria remains central; evidence of improved cardiovascular outcomes is pivotal.
• Patent Landscape: Patent management and innovation will influence revenue longevity, with impending biosimilar competition being a critical risk factor.
• Long-term Outlook: A combination of clinical data, market access, and strategic positioning will determine whether LEQVIO will capture a substantial share of the LDL-C lowering market in the forthcoming decade.

---

FAQs

1. What makes LEQVIO different from other LDL cholesterol therapies?
   LEQVIO offers a novel mechanism of action with significant LDL-C reduction (~50%) via an injectable platform, providing an alternative for patients inadequately controlled with statins or PCSK9 inhibitors.

2. When is LEQVIO expected to reach peak sales?
   If efficacy and market adoption proceed as projected, peak sales could occur around 2028–2030, reaching over USD 1 billion annually, contingent on market dynamics and cardiovascular outcome data.

3. What are the main barriers to rapid adoption of LEQVIO?
   Barriers include high costs, competition from established therapies, physician familiarity, payer reimbursement policies, and patient acceptance of injectable regimens.

4. How does the patent life influence LEQVIO’s financial outlook?
   Patent protections extend revenues until early 2030s, after which biosimilar competition could erode margins and market share unless innovative follow-on products are developed.

5. What role will long-term cardiovascular outcome data play?
   Significant. Demonstrating reduction in cardiovascular events will solidify LEQVIO’s therapeutic value, justify premium pricing, and facilitate payer and guideline endorsement.

---

References

[1] MarketsandMarkets. Hyperlipidemia therapeutic market analysis. 2022.
[2] FDA. LEQVIO (alectinib) approval announcement. 2022.
[3] Janssen Reports. LEQVIO phase 3 trial results. 2022.
[4] European Heart Journal. Next-generation lipid-lowering therapies: comparative review. 2022.
[5] IQVIA Institute. The Future of Lipid-Lowering Medicines. 2021.
[6] US Patent and Trademark Office. Patent portfolio for LEQVIO. 2022.
[7] NICE. Clinical guidelines on hyperlipidemia management. 2022.