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 nine patents protecting this drug.

This drug has one hundred and sixty-eight 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 will be eligible for patent challenges on December 22, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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 has been one patent litigation case 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:	168
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
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
Novartis Pharmaceuticals	Phase 4
Monash University	Phase 4
Medpace, Inc.	Phase 3

See all LEQVIO clinical trials

US Patents and Regulatory Information for LEQVIO

LEQVIO is protected by nine 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
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
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			Y	Y
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
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
Canada	2135499
Australia	2004233092	Modified iRNA agents
Japan	2005517438
Spain	2186690
Denmark	0725788
Japan	5635412

Supplementary Protection Certificates for LEQVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2929031	PA2021510,C2929031	Lithuania		PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209
2929031	PA2021510	Lithuania		PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209
2929031	16/2021	Austria		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 (MITTEILUNG) 20201210
2929031	21C1021	France		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210
2929031	LUC00209	Luxembourg		PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210
2929031	132021000000077	Italy		PRODUCT NAME: INCLISIRAN(LEQVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1494, 20201210

Market Dynamics and Financial Trajectory for Leqvio

Introduction

Leqvio, a revolutionary cholesterol-lowering drug developed by Novartis, has been making significant waves in the pharmaceutical industry since its approval in December 2021. Here, we delve into the market dynamics and financial trajectory of this groundbreaking medication.

Mechanism and Indications

Leqvio is a first-in-class small interfering RNA (siRNA) therapy that targets the PCSK9 gene, which regulates the amount of cholesterol in the bloodstream. Unlike other PCSK9 inhibitors such as Repatha and Praluent, which are monoclonal antibodies, Leqvio degrades the mRNA molecules used to translate genetic instructions into proteins, thereby reducing LDL cholesterol levels effectively[1][3][4].

Market Positioning

Leqvio is indicated for the treatment of low-density lipoprotein (LDL) cholesterol in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), in addition to diet and maximally tolerated statin therapy. Its unique administration schedule, requiring only two injections per year after an initial dose, sets it apart from competitors that require self-injections twice a month[1][3][4].

Launch Strategy and Uptake

Novartis adopted an unconventional launch strategy for Leqvio, focusing on large health systems in the US. This approach involves active engagement with over 200 US health systems, which represent about 65% of the ASCVD patient and prescription volume within US healthcare systems. This strategy aims to help patients who are not adequately controlling their cholesterol with existing treatments to switch to Leqvio, thereby preventing exacerbated healthcare costs and cardiac events[1].

Global Expansion

Beyond the US, Leqvio has been approved in Europe since December 2020, although its launch was impacted by COVID-19. Despite these challenges, over 70% of the UK’s primary healthcare units have Leqvio on formulary, and Novartis has integrated Leqvio into the NHS emergency health record (EHR) to identify potential patients. The drug is also seeing strong uptake in Germany, with large-scale agreements in place with some Middle East governments, and plans are underway for its launch in Japan and China[1].

Financial Performance

Since its launch, Leqvio has shown promising financial growth. In the first half of 2022, Leqvio generated $36 million in sales. By the third quarter of 2024, Leqvio's sales growth was remarkable, with a 119% increase compared to the previous year, contributing significantly to Novartis' overall sales growth of 10% and core operating income growth of 20%[2].

Sales Projections

Analysts predict a robust financial future for Leqvio. According to GlobalData, Leqvio is expected to reach $2.5 billion in sales by 2027, surpassing the projected sales of Repatha ($2.2 billion) and Praluent ($716 million) during the same period. This optimism is largely due to Leqvio's convenience edge, with its less frequent dosing schedule compared to other PCSK9 inhibitors[1][4].

Pricing and Affordability

The pricing of Leqvio is a critical factor in its market dynamics. With a wholesale acquisition cost (WAC) of $3,250 per dose, the first-year treatment cost is $9,750, and subsequent years cost $6,500. Although this is slightly higher than Repatha and Praluent, the majority of patients will have zero copays due to the drug being reimbursed through the medical benefit pathway. This includes Medicare Part B patients with supplemental insurance, which significantly enhances affordability and adherence[1][3][4].

Competitive Advantage

Leqvio's unique administration schedule and affordability model give it a competitive edge. Unlike Repatha and Praluent, which require frequent self-injections, Leqvio's twice-a-year dosing is more convenient for patients. This convenience, combined with the absence of copays for many patients, positions Leqvio favorably in the market[1][4].

Clinical and Non-Clinical Benefits

Leqvio offers significant clinical benefits, including effective and sustained LDL-C reduction of up to 52% versus placebo. It is generally well-tolerated across different patient populations. Non-clinically, Leqvio's value-based and cost-effective model helps in managing chronic disease costs, making it an attractive option for healthcare systems[3].

Future Outlook

Novartis CEO Vas Narasimhan is optimistic about Leqvio's long-term potential, citing a runway that extends into the late 2030s. With ongoing education campaigns, strong uptake in various regions, and strategic partnerships, Leqvio is poised to become a significant player in the cardiovascular disease treatment market[1].

Key Takeaways

• Unique Mechanism: Leqvio is a first-in-class siRNA therapy targeting the PCSK9 gene.
• Convenient Administration: Requires only two injections per year after an initial dose.
• Strong Financial Growth: Projected to reach $2.5 billion in sales by 2027.
• Affordability: Majority of patients have zero copays due to medical benefit pathway reimbursement.
• Global Expansion: Approved in Europe, with strong uptake in various regions and plans for further expansion.
• Competitive Edge: Convenience and affordability set it apart from other PCSK9 inhibitors.

FAQs

Q: What is the mechanism of action of Leqvio?

A: Leqvio is a small interfering RNA (siRNA) therapy that degrades the mRNA molecules used to translate genetic instructions into proteins, specifically targeting the PCSK9 gene to reduce LDL cholesterol levels.

Q: How often is Leqvio administered?

A: Leqvio is administered in two injections per year after an initial subcutaneous administration by a healthcare professional.

Q: What are the projected sales of Leqvio by 2027?

A: Analysts predict Leqvio will reach $2.5 billion in sales by 2027, surpassing the projected sales of Repatha and Praluent.

Q: How does the pricing of Leqvio compare to other PCSK9 inhibitors?

A: Leqvio's first-year treatment cost is $9,750, and subsequent years cost $6,500, which is slightly higher than Repatha and Praluent but includes zero copays for many patients due to reimbursement through the medical benefit pathway.

Q: What is the current global status of Leqvio's approval and uptake?

A: Leqvio is approved in the US and Europe, with strong uptake in the UK, Germany, and other regions, and plans are underway for its launch in Japan and China.

Sources

1. Pharmaceutical Executive: "LDL Game Changer: Leqvio"
2. Novartis: "Novartis continues strong momentum in Q3 with 10% sales growth..."
3. Novartis: "Leqvio® FDA Approval | December 23, 2021 | Novartis Investor Presentation"
4. FiercePharma: "Novartis' Leqvio to reap $2.5B by 2027 thanks to convenience edge..."