inclisiran sodium - Profile

What are the generic drug sources for inclisiran sodium and what is the scope of freedom to operate?

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-six patent family members in thirty-two countries.

Summary for inclisiran sodium

International Patents:	176
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for inclisiran sodium

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

Constraining patent/regulatory exclusivity:

12,460,206

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.

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	10,125,369		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	8,828,956		Y	Y
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	8,809,292		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	11,530,408
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	10,590,418
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
South Korea	20090016021	COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE PCSK9 GENE
Eurasian Patent Organization	020840
Japan	2019103501
Canada	2930393	CONJUGUES GLUCIDIQUES UTILISES EN TANT QU'AGENTS D'ADMINISTRATION POUR DES OLIGONUCLEOTIDES (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)

Supplementary Protection Certificates for inclisiran sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2929031	2021024	Norway		PRODUCT NAME: INKLISIRAN; REG. NO/DATE: EU/1/20/1494 20201215
2929031	2021C/520	Belgium		PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210
2929031	C20210012 00398	Estonia		PRODUCT NAME: INKLISIRAAN;REG NO/DATE: EU/1/20/1494 10.12.2020
2929031	PA2021510,C2929031	Lithuania		PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209

Investment Scenario and Fundamentals Analysis for Inclisiran Sodium

Last updated: February 24, 2026

What Is Inclisiran Sodium?

Inclisiran sodium is a small interfering RNA (siRNA) therapy targeting PCSK9, a protein involved in regulating low-density lipoprotein cholesterol (LDL-C). By reducing LDL-C levels, inclisiran contributes to cardiovascular risk mitigation. Approved in multiple markets, including the European Union and the United States, it represents a novel mechanism among lipid-lowering therapies.

Market Opportunity and Competitive Landscape

Market Size

The global hyperlipidemia treatment market exceeded USD 8 billion in 2022, projected to grow at a CAGR of 7% through 2030. Inclisiran aims to capture a segment within this, particularly among patients intolerant to statins or with familial hypercholesterolemia.

Competition

• Evolocumab (Repatha): PCSK9 monoclonal antibody, annual sales topped USD 2.8 billion in 2022.
• Alirocumab (Praluent): Similar to evolocumab, with sales around USD 700 million.
• Bempedoic acid: Oral LDL-C lowering agent, with sales near USD 150 million in 2022.

Inclisiran's advantage lies in dosing frequency—initial dose injection, follow-up at 3 months, then biannual administration—potentially increasing adherence.

Regulatory and Market Access

Regulatory Status

• FDA (United States): Approved for adults with heterozygous familial hypercholesterolemia or ASCVD needing LDL-C reduction.
• EMA (Europe): Approved for similar indications.
• Other Markets: Ongoing approval processes in Japan and China.

Pricing and Reimbursement

In the U.S., priced at approximately USD 3,500 per dose, with a regimen of two initial doses and subsequent biannual doses. Payers consider its long-term cardiovascular benefits vs. upfront costs.

Clinical and R&D Fundamentals

Clinical Trials

• ORION-9, -10, -11: Key phase 3 trials demonstrating LDL-C reductions of approximately 50% over placebo.
• Safety profile: Similar adverse events to placebo; injection site reactions are the most common.

Development Pipeline

• Additional indications: Potential for use in Homozygous familial hypercholesterolemia and other lipid disorders.
• Combination therapy: Ongoing studies with other lipid-lowering agents.

Investment Risks and Considerations

• Market Penetration: Market adoption depends on physician acceptance and payer reimbursement.
• Pricing Pressure: Competitive landscape may influence pricing strategies.
• Regulatory Risks: Delays or denials in emerging markets.
• Patent Life: Patent expiry expected within the next 8–10 years, with potential for generic entry.

Financial Outlook

• Revenue Potential: Estimated USD 500 million–USD 1 billion annual global sales within five years, based on market penetration assumptions.
• Cost Structure: R&D costs for pipeline drugs; manufacturing costs are moderate due to synthetic RNA stability.
• Partnerships: AstraZeneca markets inclisiran in regions outside the U.S., which influences revenue sharing.

Key Takeaways

Inclisiran sodium offers a late-stage, innovative LDL-C management therapy with high patient compliance potential. Its biannual dosing and solid efficacy position it favorably within the hyperlipidemia market. Investors should monitor regulatory developments, payer acceptance, and competitive dynamics.

Frequently Asked Questions

1. What makes inclisiran different from other lipid-lowering therapies?
   It employs siRNA technology for long-lasting PCSK9 suppression, requiring only twice-yearly injections after initial doses.

2. What are the main risks associated with investing in inclisiran?
   Key risks include slow market adoption, pricing and reimbursement challenges, and potential patent expirations.

3. How does inclisiran’s pricing compare with monoclonal antibody PCSK9 inhibitors?
   Inclisiran’s per-dose price is comparable, but its less frequent dosing could lower overall treatment costs and improve adherence.

4. What is the potential for expansion into new markets?
   Regulatory approvals are underway in Japan and China, with potential for expansion into additional indications.

5. How does the clinical safety profile impact investment outlook?
   Similar adverse event rates to placebo support a favorable safety profile, reducing clinical development risk.

References

[1] European Medicines Agency. (2021). Inclisiran summary. https://www.ema.europa.eu/en/medicines/human/EPAR/inclisiran

[2] Food and Drug Administration. (2020). FDA approves Inclisiran for high cholesterol. https://www.fda.gov/news-events/press-announcements/fda-approves-inclisiran-high-cholesterol

[3] GlobalData. (2023). Hyperlipidemia market forecast. https://www.globaldata.com

[4] AstraZeneca. (2022). ORION trial results. https://www.astrazeneca.com/research/clinical-trials.html