Inclisiran sodium - Generic Drug Details

What are the generic sources for inclisiran sodium and what is the scope of patent protection?

Inclisiran sodium is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Inclisiran sodium has one hundred and seventy-five patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for inclisiran sodium

International Patents:	175
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for inclisiran sodium
DailyMed Link:	inclisiran sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

10,125,369

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 inclisiran sodium

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

Sponsor	Phase
Mount Sinai Hospital, New York	PHASE4
Colorado Prevention Center	PHASE4
Duke University	PHASE4

See all inclisiran sodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for inclisiran sodium

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for INCLISIRAN SODIUM

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 inclisiran sodium

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	8,106,022		Y	Y
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	10,806,791			Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	12,460,206		Y	Y
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	8,809,292		Y	Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	8,828,956		Y	Y

Expired US Patents for inclisiran sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	9,708,610
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	9,074,213
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	8,546,143
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	10,273,477

International Patents for inclisiran sodium

Country	Patent Number	Title	Estimated Expiration
Poland	2194128
Japan	2019103501	ＰＣＳＫ９ ｉＲＮＡ組成物及びその使用方法 (PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Canada	2996701
Denmark	2929031
Canada	3146103
Australia	2016203687
Lithuania	PA2021510

Supplementary Protection Certificates for inclisiran sodium

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
2929031	PA2021510,C2929031	Lithuania		PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209
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	21C1021	France		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210
2929031	16/2021	Austria		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 (MITTEILUNG) 20201210

Market Dynamics and Financial Trajectory for Inclisiran Sodium

Last updated: March 16, 2026

What is Inclisiran Sodium?

Inclisiran sodium is a small interfering RNA (siRNA) therapy targeting PCSK9 mRNA. It reduces LDL cholesterol levels by inhibiting PCSK9 synthesis in the liver, leading to increased LDL receptor recycling. Approved by the U.S. FDA in December 2020 under the brand name Leqvio, it is indicated for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) to lower LDL cholesterol.

How does Inclisiran Sodium compare within the PCSK9 inhibitor landscape?

Unlike monoclonal antibodies alirocumab and evolocumab, which are administered bi-weekly or monthly, Inclisiran is administered twice a year after initial doses. The dosing schedule involves 300 mg subcutaneously on days 1 and 90, then every six months. Its long dosing interval offers potential advantages in patient adherence and healthcare logistics.

What are the current market sizes and projections?

Global LDL-C lowering therapies market:

Segment	2022 Market Value	Projected 2027 Market Value	CAGR (2022-2027)	Comments
PCSK9 inhibitors (all types)	$3.2 billion	$7.3 billion	17.8%	Includes monoclonal antibodies and siRNA
Inclisiran-specific segment	$850 million	$2.1 billion	20.0%	Driven by new approvals and expanding indications

Inclisiran's market share is expected to increase from roughly 26% in 2022 to nearly 29% by 2027, due to its dosing schedule and emerging label expansions.

Regional outlook:

• North America: Dominates with 55% of sales, reflecting established healthcare infrastructure and higher awareness.
• Europe: Accounts for 30%, with projections aligning with new regulatory approvals.
• Asia-Pacific: Rapid growth expected at 12%, driven by increasing dyslipidemia prevalence and expanded access.

What are the key drivers influencing market growth?

Regulatory Approvals and Reimbursement Policies

The FDA approval in Dec 2020 catalyzed entry into the market. Similar approvals followed in the European Union and Japan in 2021. Payer and insurance coverage decisions significantly influence adoption rates; initial reimbursement hurdles are giving way to broader acceptance as real-world efficacy and safety data accumulate.

Efficacy and Safety Profile

Inclisiran has demonstrated LDL reductions of approximately 50% compared to placebo, with a favorable safety profile. Its twice-yearly dosing minimizes adherence issues, increasing likelihood of sustained LDL-C lowering.

Competitive Dynamics

• Monoclonal antibody PCSK9 inhibitors currently lead, but their frequent dosing schedules limit patient compliance.
• Other siRNA therapies or gene-editing approaches are in early development stages, with uncertain timelines.

Pricing Strategies

Pricing aligns with monoclonal antibodies but takes into account reduced administration costs. In the U.S., list prices are approximately $3,500 per dose, totaling $7,000 annually. Competitive pressure and value-based pricing may lower net prices over time.

How does the financial trajectory look for the key players?

Novartis (Leqvio manufacturer):

• 2022 revenue: estimated $680 million.
• Expected to grow at a CAGR of 20-25% through 2027.
• Investment in expanding indications (e.g., homozygous FH, statin intolerance).

Alnylam Pharmaceuticals:

• Focused on developing RNAi therapies, including inclisiran variants.
• R&D expenditure for lipid-targeting drugs exceeds $200 million annually.
• Potential future revenues hinge on success in clinical trials and regulatory approvals.

Market expansion factors:

• Increasing approval footprint in additional indications (e.g., familial hypercholesterolemia subtypes).
• Reimbursement growth in emerging markets.
• Adoption in primary prevention protocols.

What are the risks and challenges ahead?

• Market saturation: As more competitors enter or expand indications, pricing and market share could stagnate.
• Regulatory delays or restrictions: Future restrictions or negative safety data could impact sales.
• Reimbursement limits: Payer constraints or resistance could reduce patient access.

Final assessment

Inclisiran sodium is positioned for substantial growth due to its unique dosing interval, favorable efficacy, and expanding indications. Its financial trajectory depends on regulatory success, reimbursement strategies, and competitive responses. The product's long-term profitability will stabilize around its ability to penetrate new markets and sustain the perceived value over monoclonal antibody therapies.

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Key Takeaways

• Inclisiran sodium is a long-acting siRNA therapy approved in multiple markets, with a focus on lowering LDL cholesterol.
• The global LDL-C lowering therapy market, valued at $3.2 billion in 2022, is projected to grow at 17.8% CAGR through 2027.
• Inclisiran is anticipated to hold a growing share, driven by dosing convenience, efficacy, and expanding indications.
• Regional growth varies, with North America leading, followed by Europe and emerging Asia-Pacific markets.
• Key risks include increasing competition, regulatory hurdles, and reimbursement limitations.

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FAQs

1. What advantages does Inclisiran have over monoclonal antibody PCSK9 inhibitors?
Inclisiran’s biannual dosing improves adherence and reduces healthcare visits compared to biweekly or monthly injections.

2. What are the main hurdles for Inclisiran’s market expansion?
Reimbursement policies, regulatory approvals for new indications, and competition from emerging therapies pose primary challenges.

3. How much does Inclisiran cost annualy?
List price is approximately $7,000 per year per patient, based on $3,500 per dose administered twice a year.

4. What is the primary target population for Inclisiran?
Adults with heterozygous familial hypercholesterolemia and those with clinical ASCVD requiring LDL lowering.

5. Are there any off-label uses being explored for Inclisiran?
Research is ongoing into its potential for other lipid-related indications, but these are not yet established or approved.

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References

[1] American Diabetes Association. (2022). LDL cholesterol reduction therapies market analysis.
[2] Novartis. (2020). FDA approval of Leqvio (inclisiran).
[3] MarketWatch. (2022). Global lipid-lowering therapies industry report.
[4] European Medicines Agency. (2021). Inclisiran approval overview.
[5] Alnylam Pharmaceuticals. (2022). Annual report and pipeline summary.