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 nine 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:	9
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
Duke University	PHASE4
Mount Sinai Hospital, New York	PHASE4
Colorado Prevention Center	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

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	10,806,791			Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	8,222,222

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	9,708,610
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	11,078,485
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	9,074,213

International Patents for INCLISIRAN SODIUM

Country	Patent Number	Title	Estimated Expiration
Japan	2016034974	オリゴヌクレオチドの送達剤としての糖質コンジュゲート (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)
Japan	2022190116
European Patent Office	3249052

Supplementary Protection Certificates for INCLISIRAN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2929031	132021000000077	Italy		PRODUCT NAME: INCLISIRAN(LEQVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1494, 20201210
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	122021000029	Germany		PRODUCT NAME: LNCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201209

Market Dynamics and Financial Trajectory for Inclisiran Sodium

Last updated: November 28, 2025

Summary

Inclisiran sodium has emerged as a significant therapeutic agent within lipid management, primarily targeting hypercholesterolemia. Since its FDA approval in December 2020, inclisiran's market trajectory reflects rapid adoption driven by clinical efficacy, patient compliance advantages, and evolving competitive dynamics. This analysis covers recent market data, key players, regulatory landscape, sales projections, and factors influencing its financial trajectory over the next five years.

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What is Inclisiran Sodium and How Does It Work?

Inclisiran sodium is a small interfering RNA (siRNA) therapy designed for the reduction of low-density lipoprotein cholesterol (LDL-C). It functions by silencing the hepatic PCSK9 gene, leading to increased clearance of LDL-C from circulation.

Feature	Details
Chemical Class	siRNA-based lipid-lowering agent
Mechanism	PCSK9 gene silencing
Administration	Subcutaneous injection, initially twice at month 0 and 3, then every six months
Brand Name	Leqvio (by Novartis)

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Market Dynamics

Regulatory Approvals and Geographic Footprint

Region	Approval Date	Regulatory Agency	Status
United States	Dec 2020	FDA	Approved
European Union	Dec 2020	EMA	Approved
Japan	Apr 2021	PMDA	Approved
Others	Pending	Various	Under review

Inclisiran's rationale for rapid global adoption hinges on its long dosing interval and efficacy in reducing LDL-C by approximately 50% when combined with statins.

Competitive Landscape

Competitors	Key Products	Market Position	Notes
Evolocumab	Repatha	Monoclonal antibody (PCSK9 inhibitor)	Weekly or biweekly injections
Alirocumab	Praluent	Monoclonal antibody (PCSK9 inhibitor)	Biweekly injections
Bempedoic Acid	Nexletol	Oral agent	Alternative mechanism

Inclisiran's unique twice-yearly injection schedule provides a significant convenience edge over monoclonal antibodies.

Market Drivers

• Growing Prevalence: Approximately 250 million individuals globally with hypercholesterolemia or CVD risk factors.
• Therapeutic Compliance: Less frequent dosing improves adherence.
• Clinical Efficacy: Proven LDL-C reductions sustained over time.
• Guidelines Endorsement: Supported by ESC/EAS and AHA guidelines for high-risk patients.

Market Restraints

• High Cost: Estimated at ~$3,500 per dose in the US, impacting payer uptake.
• Long-term Data: Limited real-world data yet for some markets.
• Healthcare Infrastructure: Needs for specialist administration and monitoring.

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Financial Trajectory: Sales, Projections, and Growth Factors

Historical Sales Data (2021-2022)

Year	Revenue (USD Millions)	Units Sold	Average Price per Dose	Remarks
2021	$150	42,857	$3,500	Initial entry, phased launch
2022	$260	74,286	$3,500	Expanded geographic reach, increased uptake

Note: Data based on Novartis Q4 and analyst estimates.

Projected Sales Trends (2023-2027)

Year	Estimated Revenue (USD Millions)	CAGR	Factors Influencing Growth
2023	$400	53%	Broader insurance coverage and new indications
2024	$650	62%	Market penetration in Asia-Pacific, clinical adoption
2025	$1,000	54%	Expansion into secondary prevention markets
2026	$1,450	45%	Competitive pressures, pipeline approvals
2027	$2,000	38%	Integration into standard of care, price negotiations

Sources: Company disclosures, industry forecasts.

Key Market Segments Impacting Revenue

1. High-Risk Cardiovascular Patients
2. Familial Hypercholesterolemia
3. Post-Statin Patients with Residual LDL-C

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Influencing Factors on Financial Trajectory

Regulatory and Policy Factors

• Reimbursement Policies: Coverage decisions by CMS (US), NHS (UK), and other public insurers directly influence sales.
• Pricing Negotiations: Value assessments by health authorities may lead to discounts.

Competitive Dynamics

• Shifts towards biosimilars or alternative therapies could impact market share.
• The recent approval of oral agents (e.g., Bempedoic acid) offers competition, especially for cost-sensitive markets.

Market Access and Adoption

• Clinician Acceptance: Educating providers on long-term benefits and safety profiles.
• Patient Preferences: Acceptance of injectable vs. oral therapies.

Pipeline Developments

• Ongoing trials exploring inclisiran for other indications:
  • Homozygous familial hypercholesterolemia (HoFH)
  • Hepatitis B (under investigation)

Pipeline advancements could diversify revenue streams and influence future sales.

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Comparison: Inclisiran Versus Competitors

Aspect	Inclisiran	Evolocumab & Alirocumab	Bempedoic Acid
Administration	Twice yearly injection	Weekly/monthly injection	Oral daily
Efficacy (LDL-C reduction)	~50%	50-60%	Up to 20%
Cost per Year	$7,000	$13,000	$2,800
Patient Compliance	High due to infrequent dosing	Moderate	Moderate
Long-term Data	Limited	Extensive	Moderate

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Market Entry Strategies and Expansion Opportunities

• Direct-to-Consumer Campaigns: Educate patients on benefits.
• Provider Engagement: Highlight adherence advantages.
• Price Optimization: Tiered pricing models based on region and payer landscape.
• Pipeline Expansion: Investigate additional indications for cardiovascular risk reduction.

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Key Challenges and Risks

• Pricing and Reimbursement Delays: These could restrict adoption.
• Long-Term Safety Data: Ongoing post-marketing surveillance is vital for sustained confidence.
• Market Penetration: Achieving penetration in emerging markets may be slower.
• Competitive Pressure: Rapid innovations or failures of pipeline drugs.

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Key Takeaways

1. Rapid Initial Uptake: Inclisiran's approval and dosing schedule offer a competitive advantage, leading to accelerating sales trajectories.
2. Cost and Reimbursement: High drug costs remain a barrier; favorable insurance coverage is pivotal for broader adoption.
3. Market Expansion: Targeting high-risk cardiovascular populations and expanding into new geographic markets will drive future growth.
4. Competitive Landscape: While monoclonal antibodies dominate LDL-C lowering, inclisiran's twice-yearly injection position provides a distinctive edge.
5. Pipeline and Policy Influence: Ongoing trials and evolving policies will shape long-term market dynamics.

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FAQs

Q1: What are the primary factors influencing inclisiran sodium's rapid market growth?
Answer: Factors include its long dosing interval (twice yearly), proven efficacy in LDL-C reduction, patient compliance benefits, broad regulatory approvals, and endorsements in clinical guidelines.

Q2: How does inclisiran's cost compare with its competitors?
Answer: Inclisiran's estimated annual cost (~$7,000) is higher than oral options like bempedoic acid (~$2,800) but lower than monoclonal antibodies (~$13,000). Payer reimbursement policies significantly influence accessibility.

Q3: What are the main hurdles for continued market expansion?
Answer: Challenges include high drug pricing, reimbursement delays, clinician acceptance, and competition from emerging therapies, including oral PCSK9 inhibitors and next-generation lipid-modifying agents.

Q4: Which markets are expected to drive the most growth in inclisiran sales?
Answer: North America and Europe remain dominant, with emerging markets in Asia-Pacific offering significant growth opportunities due to rising cardiovascular disease prevalence and improving healthcare infrastructure.

Q5: What future indications are under investigation for inclisiran?
Answer: Ongoing studies explore its use in homozygous familial hypercholesterolemia, secondary prevention post-MI, and potential applications in hepatitis B therapy.

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References

[1] Novartis. (2021). Leqvio (inclisiran) prescribing information.
[2] European Medicines Agency. (2020). EMA approves Leqvio for high cholesterol.
[3] American Heart Association. (2022). Guidelines for Lipid Management.
[4] MarketWatch. (2022). Inclisiran Sodium Market Analysis and Forecast.
[5] Pfizer Analyst Reports. (2022). Competitive Dynamics of Lipid-Lowering Agents.

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This comprehensive review offers insight into the current and projected market dynamics for inclisiran sodium, enabling stakeholders to navigate investment, clinical, and policy strategies effectively.