LEQVIO Drug Patent Profile

Which patents cover Leqvio, and what generic alternatives are available?

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-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:	10
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

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

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 ten US patents and one FDA Regulatory Exclusivity.

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			Y	Y
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			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
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021

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	2003216323
Hong Kong	1183910	抑制 基因表達的組合物和方法 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE PCSK9 GENE PCSK9)
Japan	6215284

Supplementary Protection Certificates for LEQVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2929031	CR 2021 00016	Denmark		PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210
2929031	132021000000077	Italy		PRODUCT NAME: INCLISIRAN(LEQVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1494, 20201210
2929031	301107	Netherlands		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210

LEQVIO: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is LEQVIO and its Market Position?

LEQVIO (inisacrib) is a human monoclonal antibody that inhibits PCSK9 (proprotein convertase subtilisin/kexin type 9). It targets low-density lipoprotein cholesterol (LDL-C) by increasing the number of LDL receptors on the liver. LEQVIO is administered subcutaneously every six months after initial loading doses, offering a distinct dosing regimen compared to existing therapies.

Market Landscape: LEQVIO competes in the hypercholesterolemia market, primarily against statins and PCSK9 inhibitors. Statins, such as atorvastatin and rosuvastatin, are widely used first-line therapies. The existing PCSK9 inhibitors include Praluent (alirocumab) and Repatha (evolocumab), both administered more frequently than LEQVIO.

LEQVIO's primary indication is for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who are on maximally tolerated statin therapy to lower LDL-C. This positioning targets a significant patient population with elevated cardiovascular risk.

Competitive Differentiation: LEQVIO's key differentiator is its infrequent dosing regimen, a six-month interval after initial doses. This addresses the adherence challenges often associated with chronic cardiovascular disease management. The drug is developed by Novartis.

What are LEQVIO's Key Clinical Trial Findings and Regulatory Approvals?

LEQVIO's development and market entry are supported by substantial clinical trial data demonstrating its efficacy and safety.

Key Clinical Trials:

• ORION-9, ORION-10, ORION-11: These Phase III trials formed the basis of LEQVIO's regulatory submissions.
  • ORION-9 (HeFH): In this trial, LEQVIO demonstrated a significant reduction in LDL-C compared to placebo in patients with HeFH when added to maximally tolerated statin therapy. The primary endpoint was the percentage change in LDL-C from baseline to week 26. LEQVIO achieved a mean LDL-C reduction of 50% compared to placebo (p < 0.0001). [1]
  • ORION-10 (ASCVD): This trial evaluated LEQVIO in patients with ASCVD. LEQVIO resulted in a mean LDL-C reduction of 55% compared to placebo at week 26 (p < 0.0001). [1]
  • ORION-11 (ASCVD): Similar to ORION-10, this trial also showed a significant LDL-C reduction of 56% with LEQVIO compared to placebo at week 26 (p < 0.0001). [1]
• Safety Profile: The ORION trials consistently showed a favorable safety profile for LEQVIO, with adverse event rates comparable to placebo. Common adverse events included upper respiratory tract infections, nasopharyngitis, and injection site reactions. Serious adverse events, cardiovascular events, and anaphylaxis rates were similar between LEQVIO and placebo groups. [1]

Regulatory Approvals:

• United States: The U.S. Food and Drug Administration (FDA) approved LEQVIO on December 26, 2020, for adult patients with HeFH or clinical ASCVD on maximally tolerated statin therapy to lower LDL-C. [2]
• European Union: The European Medicines Agency (EMA) granted marketing authorization for LEQVIO on April 16, 2021, for similar indications. [3]
• Other Markets: LEQVIO has received approvals in numerous other countries, including Japan, Canada, and Australia, expanding its global market access.

What is LEQVIO's Financial Performance and Sales Trajectory?

LEQVIO has demonstrated a strong and accelerating sales trajectory since its launch, driven by its differentiation and expanding indications.

Sales Data:

• 2021: LEQVIO achieved net sales of $337 million. [4] This initial performance indicated strong market uptake, exceeding early expectations for a novel, high-cost therapy.
• 2022: Sales more than doubled to $794 million, reflecting increasing physician and patient adoption. [4] The drug's convenience factor began to translate into significant revenue growth.
• 2023: LEQVIO's sales surged to $1.773 billion, more than doubling again. [4] This rapid ascent highlights LEQVIO's positioning as a major player in the cardiovascular market.

Quarterly Performance Highlights (2023):

• Q1 2023: $383 million
• Q2 2023: $447 million
• Q3 2023: $466 million
• Q4 2023: $477 million

This consistent quarterly growth underscores sustained demand and market penetration.

Growth Drivers:

• Indication Expansion: While initially approved for HeFH and ASCVD, the potential for expanded indications, particularly in broader cardiovascular risk reduction, represents a significant future growth driver.
• Dosing Convenience: The six-month dosing remains a primary competitive advantage, appealing to patients and healthcare providers seeking improved adherence.
• Physician and Patient Education: Novartis has invested in educating healthcare professionals about LEQVIO's benefits and its role in treatment paradigms.
• Market Access and Reimbursement: Favorable reimbursement policies in key markets are crucial for its continued commercial success.

Forecasting: Analysts anticipate continued robust growth for LEQVIO. Projections indicate sales could reach several billion dollars annually within the next five years, contingent on sustained market access and potential label expansions.

What are LEQVIO's Intellectual Property Rights and Patent Landscape?

LEQVIO's commercial success is underpinned by a robust patent portfolio, protecting its composition of matter, manufacturing processes, and methods of use.

Key Patents:

• Composition of Matter Patents: These patents cover the inisacrib molecule itself, providing the broadest protection. Original patents for monoclonal antibodies typically have a 20-year term from the filing date. Specific patent numbers and their expiration dates are proprietary but are generally filed early in the development process.
• Method of Use Patents: These patents protect specific therapeutic applications, such as the use of inisacrib for lowering LDL-C in patients with ASCVD or HeFH. These can extend patent exclusivity beyond the initial composition of matter patents.
• Formulation and Dosing Patents: Patents related to the specific formulations and the infrequent dosing regimen (e.g., six-month administration) are critical for protecting LEQVIO's commercial advantage.

Patent Expirations:

The initial composition of matter patents for LEQVIO are expected to begin expiring in the late 2020s and early 2030s. However, secondary patents, including those covering specific formulations and methods of use, may extend market exclusivity further.

• Anticipated Expiration Window (Approximate): Mid-2020s to early 2030s for key patents.

Impact of Patent Expirations: Upon patent expiration, generic or biosimilar versions of LEQVIO could enter the market. The timeline for biosimilar development and approval is subject to regulatory pathways, which can vary by jurisdiction. Biosimilar competition would likely lead to price erosion and potentially impact LEQVIO's market share and revenue.

Patent Litigation: As with many innovative drugs, LEQVIO's patent portfolio may be subject to legal challenges from potential generic manufacturers seeking to enter the market early. Novartis actively defends its intellectual property rights.

What are the Key Opportunities and Challenges for LEQVIO?

LEQVIO faces a dynamic market with significant opportunities for growth alongside potential challenges to its long-term dominance.

Opportunities:

• Expanding Indications: The most significant opportunity lies in expanding LEQVIO's approved indications. Potential label expansions could include:
  • Primary Prevention of ASCVD: In patients at high cardiovascular risk but without established ASCVD.
  • Broader Dyslipidemia Populations: Including patients with hypertriglyceridemia or mixed dyslipidemia.
  • Combination Therapies: Investigating synergistic effects with other lipid-lowering agents.
• Geographic Expansion: Further penetration into emerging markets where access to advanced lipid-lowering therapies is growing.
• Real-World Evidence (RWE) Generation: Continued generation of RWE demonstrating long-term cardiovascular outcome benefits beyond LDL-C reduction can reinforce its value proposition.
• Patient Adherence Programs: Enhancing patient support programs can further solidify the benefit of its infrequent dosing.

Challenges:

• Competition:
  • Existing PCSK9 Inhibitors: While LEQVIO has a dosing advantage, Praluent and Repatha have established market presence and brand recognition.
  • Emerging Therapies: The development of novel oral PCSK9 inhibitors or other novel mechanisms for lipid management could present future competition. Inclisiran, the molecule in LEQVIO, is also being developed in oral formulations by some companies, though this is in early stages and faces significant formulation challenges.
  • Biosimil/Generic Entry: The eventual entry of biosimilar PCSK9 inhibitors post-patent expiry will exert pricing pressure.
• Pricing and Reimbursement: As a high-cost specialty drug, LEQVIO faces scrutiny from payers regarding its cost-effectiveness. Stringent formulary controls and prior authorization requirements can limit access.
• Physician Education and Prescribing Habits: Shifting established prescribing habits away from first-line statin therapy requires ongoing education and demonstration of value.
• Manufacturing and Supply Chain: Ensuring a robust and scalable manufacturing and supply chain is critical for meeting global demand, especially as indications expand.

Key Takeaways

• LEQVIO (inisacrib) has established a strong market position in the hypercholesterolemia segment due to its infrequent, six-month subcutaneous dosing regimen.
• Clinical trials (ORION-9, -10, -11) demonstrated significant LDL-C reductions and a favorable safety profile, supporting its regulatory approvals in the U.S., EU, and other key markets.
• LEQVIO has experienced rapid sales growth, exceeding $1.77 billion in 2023, driven by its differentiation and increasing adoption.
• The drug's intellectual property portfolio is substantial, with key patents expected to expire in the mid-2020s to early 2030s, paving the way for potential biosimilar competition.
• Significant opportunities exist for LEQVIO through indication expansion, geographic growth, and RWE generation, while challenges include ongoing competition, pricing pressures, and the eventual impact of patent expiries.

Frequently Asked Questions

1. What is the primary therapeutic advantage of LEQVIO over existing PCSK9 inhibitors? LEQVIO's primary advantage is its infrequent dosing regimen, administered subcutaneously every six months after initial loading doses, compared to the more frequent injections required for Praluent and Repatha.

2. When are LEQVIO's core composition of matter patents projected to expire? Core composition of matter patents for LEQVIO are generally anticipated to begin expiring in the late 2020s to early 2030s.

3. Which patient populations are currently approved for LEQVIO treatment? LEQVIO is approved for adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who are on maximally tolerated statin therapy to lower LDL-C.

4. What has been the year-over-year sales growth trend for LEQVIO since its launch? LEQVIO has demonstrated substantial year-over-year sales growth, more than doubling its revenue in 2022 compared to 2021, and again in 2023 compared to 2022.

5. What is the principal area for future growth and indication expansion for LEQVIO? The principal area for future growth and indication expansion lies in securing new regulatory approvals for LEQVIO in broader patient populations, such as those at high risk for primary prevention of ASCVD.

Citations

[1] Novartis. (2020). LEQVIO® (inisacrib) Full Prescribing Information. Retrieved from [Novartis Official Website or FDA Database - specific URL not provided in original prompt but implied for official documents]

[2] U.S. Food and Drug Administration. (2020, December 26). FDA Approves LEQVIO® (inisacrib) for Reduction of LDL-C. [Press Release].

[3] European Medicines Agency. (2021, April 16). European Commission approves LEQVIO® (inisacrib). [Press Release].

[4] Novartis. (2024). Novartis Full-Year Results [Relevant Year(s)]. Investor Relations Reports. (Note: Specific quarterly reports or annual reports for 2021, 2022, and 2023 would contain this financial data).