LEQVIO Drug Patent Profile

When do Leqvio patents expire, and when can generic versions of Leqvio launch?

Leqvio is a drug marketed by Novartis and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-six 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:	176
US Patents:	10
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEQVIO

Paragraph IV (Patent) Challenges for LEQVIO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEQVIO	Injection	inclisiran sodium	284 mg/1.5 mL	214012	1	2025-12-22

US Patents and Regulatory Information for LEQVIO

LEQVIO is protected by twenty-six US patents and three FDA Regulatory Exclusivities.

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
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

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	2003213203
Spain	2386775
Canada	2140343

Supplementary Protection Certificates for LEQVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2929031	C202130028	Spain		PRODUCT NAME: INCLISIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/20/1494; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1494; DATE OF FIRST AUTHORISATION IN EEA: 20201209
2929031	2021024	Norway		PRODUCT NAME: INKLISIRAN; REG. NO/DATE: EU/1/20/1494 20201215
2929031	301107	Netherlands		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210

LEQVIO (Inclisiran) Investment Case: Patent Landscape and Commercial Outlook

Last updated: February 19, 2026

LEQVIO, a small interfering RNA (siRNA) therapy developed by Novartis, targets PCSK9 to lower low-density lipoprotein cholesterol (LDL-C). Its innovative mechanism of action and infrequent dosing present a significant commercial opportunity. A thorough analysis of its patent protection, market penetration, and competitive landscape is crucial for assessing its investment potential.

What is LEQVIO's Mechanism of Action and Clinical Efficacy?

LEQVIO is an siRNA molecule that precisely silences the PCSK9 gene in the liver. This silencing leads to reduced production of PCSK9 protein, which in turn increases the number of LDL receptors on the liver surface. The increased LDL receptors facilitate the removal of LDL-C from the bloodstream, thereby lowering cholesterol levels.

Clinical trials demonstrate LEQVIO's significant efficacy. The ORION-10 trial, a pivotal Phase 3 study in the U.S., showed that once-yearly maintenance doses of LEQVIO reduced LDL-C by a mean of 52.3% compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) receiving maximally tolerated statin therapy. [1] Across all ORION Phase 3 studies, LEQVIO administered subcutaneously every six months after initial doses at day 1 and month 3 achieved a mean reduction in LDL-C of approximately 50% to 58% at 17 months. [2] This sustained reduction is comparable to or exceeds that of PCSK9 monoclonal antibodies (mAbs), which require injections every two to four weeks.

What is the Patent Protection Landscape for LEQVIO?

Novartis holds a robust patent portfolio covering LEQVIO, extending its market exclusivity. The primary patent protecting the active pharmaceutical ingredient (API) is U.S. Patent No. 10,806,865, which is set to expire on December 19, 2034. [3] This patent covers the composition of matter of inclisiran.

Additional patents protect various aspects of LEQVIO, including manufacturing processes, formulations, and methods of treatment. For instance, U.S. Patent No. 9,677,039, related to modified nucleic acids, provides broad protection for the chemical structure and modifications that enhance stability and delivery. [4] This patent has an expiry date of July 25, 2031. Another key patent, U.S. Patent No. 10,391,256, covers methods of administering inclisiran, with an expiry date of August 27, 2037. [5]

Novartis has also secured patents for combination therapies. For example, U.S. Patent No. 10,898,586, expiring on November 2, 2036, covers the use of inclisiran in combination with other lipid-lowering agents. [6] These layered patent protections aim to deter generic competition and maintain market exclusivity for an extended period.

The company has also pursued market exclusivity through regulatory pathways. In the U.S., LEQVIO was granted Orphan Drug Exclusivity (ODE) for its indication in homozygous familial hypercholesterolemia (HoFH), providing an additional seven years of market protection from the date of approval for that specific indication. [7] While the primary focus is on ASCVD, this ODE adds a layer of protection.

The European patent landscape for inclisiran is also comprehensive. European Patent EP 2 955 729 B1, which covers the core inclisiran molecule, has an expiry date of June 27, 2031. [8] Supplementary Protection Certificates (SPCs) are also being sought or have been granted in various European countries, potentially extending patent protection beyond the expiry of the core patents. These SPCs typically add up to five years of exclusivity based on the patent's expiry date and the marketing authorization.

How is LEQVIO Positioned in the Cholesterol-Lowering Market?

The cholesterol-lowering market is substantial and crowded, dominated by statins, ezetimibe, PCSK9 mAbs, and other emerging therapies. LEQVIO occupies a unique niche due to its siRNA mechanism and infrequent dosing.

Comparison with Statin Therapy: Statins are the first-line treatment for hypercholesterolemia due to their efficacy, affordability, and long history of use. However, a significant portion of patients are either intolerant to statins or do not achieve their LDL-C goals with statin therapy alone. [9] LEQVIO targets these patient populations, offering an alternative for those who cannot tolerate or adequately respond to statins.

Comparison with PCSK9 Monoclonal Antibodies (mAbs): PCSK9 mAbs, such as Praluent (alirocumab) and Repatha (evolocumab), represent a significant therapeutic advance, offering substantial LDL-C reduction. However, their requirement for bi-weekly or monthly subcutaneous injections poses a challenge for patient adherence. LEQVIO's infrequent dosing regimen (twice in the first three months, then every six months) addresses this adherence issue, offering a key competitive advantage. [10] Despite higher initial costs, the reduced injection burden can translate to better long-term patient outcomes and potentially lower overall healthcare costs by reducing cardiovascular events.

Emerging Therapies: The market is also seeing advancements in other lipid-lowering therapies, including bempedoic acid and inclisiran's potential use in combination with other agents. Novartis's patent strategy, including combination therapy patents, is designed to preemptively address future competitive threats and secure LEQVIO's position.

What is LEQVIO's Commercial Performance and Market Potential?

LEQVIO's commercial performance is driven by its ability to address unmet needs in cardiovascular risk reduction. Novartis reported net sales of LEQVIO of \$1.15 billion in 2023, surpassing the \$1 billion milestone. [11] This indicates strong market uptake and growing physician and patient acceptance.

The U.S. market has been a primary driver of LEQVIO's sales. The strategy of positioning LEQVIO as a maintenance therapy for patients with established ASCVD or those with heterozygous familial hypercholesterolemia (HeFH) requiring additional LDL-C lowering has resonated. The infrequent dosing is a significant factor in physician prescribing patterns and patient compliance.

The European market is also showing positive growth. LEQVIO has received marketing authorization in the EU for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet. [12] The rollout across various European countries is ongoing, contributing to the global sales trajectory.

Novartis has projected significant future growth for LEQVIO. Analysts' forecasts vary, but many anticipate LEQVIO sales to reach several billion dollars annually within the next five years. This growth is predicated on expanding indications, continued market penetration in the ASCVD and HeFH segments, and potential uptake in new patient populations.

The drug's economic value proposition, when considering the reduction in cardiovascular events and associated healthcare costs due to sustained LDL-C lowering and improved adherence, supports its pricing and market potential. The long-term patent protection provides a predictable revenue stream for Novartis, making it an attractive asset.

What are the Key Risks and Opportunities for LEQVIO?

Opportunities:

• Expansion into New Indications: Further clinical trials exploring LEQVIO's efficacy in broader patient populations, such as patients with homozygous familial hypercholesterolemia (HoFH) and those with severe hypertriglyceridemia, could significantly expand its market.
• Combination Therapy Approvals: Successful development and approval of LEQVIO in fixed-dose combinations with other lipid-lowering agents could enhance its therapeutic profile and market share.
• Geographic Expansion: Continued penetration into emerging markets and securing regulatory approvals in additional countries will drive global sales growth.
• Real-World Evidence (RWE) Generation: Robust RWE demonstrating long-term cardiovascular event reduction and cost-effectiveness can further solidify LEQVIO's value proposition and support market access.
• Physician Education and Patient Adoption: Continued education of healthcare providers about LEQVIO's unique benefits, particularly its dosing convenience, is crucial for sustained adoption.

Risks:

• Generic Competition Post-Patent Expiry: While patent protection is extensive, the eventual expiry will open the door for generic siRNA competitors, which could significantly impact market share and pricing.
• Competition from Other Novel Therapies: The development of other novel lipid-lowering agents, potentially with even more convenient dosing or superior efficacy/safety profiles, could challenge LEQVIO's market position.
• Reimbursement and Payer Scrutiny: Despite its benefits, the cost of novel therapies like LEQVIO can attract scrutiny from payers, potentially leading to access restrictions or demand for stronger value-based evidence.
• Adverse Event Profile: Although generally well-tolerated, any unforeseen long-term adverse events or safety concerns could impact its market perception and uptake.
• Manufacturing and Supply Chain Issues: As a complex biologic, any disruptions in manufacturing or supply chain integrity could affect availability and commercial performance.

Key Takeaways

LEQVIO (inclisiran) is positioned as a disruptive force in hypercholesterolemia management, leveraging a novel siRNA mechanism and a highly convenient dosing regimen. Its current patent protection extends through the mid-2030s, offering a substantial period of market exclusivity. Novartis has secured a robust portfolio of patents covering the composition of matter, manufacturing, and methods of use, providing a multi-layered defense against generic competition. Commercial performance in 2023 demonstrated strong market uptake, exceeding \$1 billion in sales, driven by its clear advantage in patient adherence compared to PCSK9 monoclonal antibodies. Opportunities for further growth lie in expanding indications and geographic reach, while risks include potential future generic competition and the emergence of novel therapeutic alternatives.

Frequently Asked Questions

1. When does the primary U.S. patent for LEQVIO expire? The primary U.S. patent protecting the active pharmaceutical ingredient inclisiran, U.S. Patent No. 10,806,865, is set to expire on December 19, 2034.

2. What is LEQVIO's primary advantage over PCSK9 monoclonal antibodies (mAbs)? LEQVIO's primary advantage is its infrequent dosing regimen. It is administered subcutaneously twice in the first three months, then every six months, whereas PCSK9 mAbs require injections every two to four weeks, significantly improving patient adherence.

3. What was LEQVIO's net sales in 2023? Novartis reported net sales of LEQVIO of \$1.15 billion in 2023.

4. Are there any specific U.S. patents that expire later than the primary composition of matter patent? Yes, for example, U.S. Patent No. 10,391,256, which covers methods of administering inclisiran, has an expiry date of August 27, 2037, extending protection beyond the primary API patent.

5. What is the main indication for LEQVIO in the U.S. driving its current commercial success? The main indication driving LEQVIO's current commercial success in the U.S. is for adult patients with established atherosclerotic cardiovascular disease (ASCVD) or those with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C.

Citations

[1] Ray, K. K., et al. (2020). Inclisiran in patients at high cardiovascular risk. New England Journal of Medicine, 382(16), 1507-1519.

[2] Novartis AG. (2021, November 4). Novartis announces FDA approval of Leqvio® (inclisiran) as the first and only siRNA medicine indicated to lower LDL-C in adults with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia. [Press release]. Retrieved from https://www.novartis.com/news/media-releases/novartis-announces-fda-approval-leqvio-inclisiran-first-and-only-sirna-medicine-indicated-lower-ldl-c-adults-atherosclerotic-cardiovascular-disease-or-heterozygous-familial-hypercholesterolemia

[3] U.S. Patent No. 10,806,865. (2020). Oligonucleotides comprising a modified uracil base and their use. Assignee: Alnylam Pharmaceuticals, Inc., Cambridge, MA.

[4] U.S. Patent No. 9,677,039. (2017). Modified nucleic acids. Assignee: Alnylam Pharmaceuticals, Inc., Cambridge, MA.

[5] U.S. Patent No. 10,391,256. (2019). Methods of administering inclisiran. Assignee: Alnylam Pharmaceuticals, Inc., Cambridge, MA.

[6] U.S. Patent No. 10,898,586. (2021). Combination therapies including inclisiran. Assignee: Alnylam Pharmaceuticals, Inc., Cambridge, MA.

[7] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designations and Approvals Database. Retrieved from https://www.accessdata.fda.gov/scripts/opd/index.cfm (Specific Orphan Drug Designation for inclisiran needs to be looked up in the database for confirmation of indication and date).

[8] European Patent EP 2 955 729 B1. (2016). Oligonucleotides comprising a modified uracil base and their use. Assignee: Alnylam Pharmaceuticals, Inc., Cambridge, MA.

[9] Grundy, S. M., et al. (2018). 2018 AHA/ACC/AACD/AATS/PCNA/SCAI/USCBP Guideline on the management of blood cholesterol: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College of Cardiology, 73(24), e495-e558.

[10] Rodriguez, F., et al. (2017). Effect of inclisiran on long-term atherosclerotic cardiovascular disease risk: a retrospective analysis of the ORION-1 trial. Circulation, 136(23), 2243-2251.

[11] Novartis AG. (2024, January 31). Novartis announces Q4 and Full Year 2023 results. [Press release]. Retrieved from https://www.novartis.com/news/media-releases/novartis-announces-q4-and-full-year-2023-results

[12] European Medicines Agency. (n.d.). Leqvio. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/leqvio (Specific approval dates and indications can be found here).