Inclisiran sodium - Generic Drug Details

What are the generic drug 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 sixty-eight patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for inclisiran sodium

International Patents:	168
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
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

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
Novartis Pharmaceuticals	Phase 4
Novartis Pharmaceuticals	Phase 2
University of Oxford	Phase 3

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			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
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

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
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 inclisiran sodium

Country	Patent Number	Title	Estimated Expiration
South Korea	20150091097	PCSK9 iRNA 조성물 및 그 사용 방법 (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
European Patent Office	4321177	CONJUGUÉS GLUCIDIQUES UTILISÉS COMME AGENTS D'ADMINISTRATION POUR DES OLIGONUCLÉOTIDES (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)
Japan	2023010881	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
Japan	5635412
Australia	2024278345	Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
Japan	2023103244	ＰＣＳＫ９ ｉＲＮＡ組成物及びその使用方法 (PCSK9 iRNA COMPOSITIONS AND METHODS FOR USE THEREOF)

Supplementary Protection Certificates for inclisiran sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2929031	C02929031/01	Switzerland		PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67836 09.09.2021
2929031	2021C/520	Belgium		PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210
2929031	2021024	Norway		PRODUCT NAME: INKLISIRAN; REG. NO/DATE: EU/1/20/1494 20201215
2929031	132021000000077	Italy		PRODUCT NAME: INCLISIRAN(LEQVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1494, 20201210
2929031	PA2021510	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

Market Dynamics and Financial Trajectory for Inclisiran Sodium

Introduction

Inclisiran sodium, marketed as Leqvio, is a groundbreaking therapy for lowering low-density lipoprotein cholesterol (LDL-C) levels, particularly in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH). Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Approval and Regulatory Landscape

Inclisiran has been approved in over 70 countries, including the EU and the USA, for the treatment of hypercholesterolemia in patients with ASCVD or HeFH. This widespread approval underscores its potential to address a significant unmet medical need globally[1][3][5].

Clinical Efficacy and Safety

Clinical trials, including those in the ORION series, have demonstrated inclisiran's consistent and remarkable LDL-C lowering effect, with reductions of approximately 50% when administered twice yearly. Long-term data show that inclisiran maintains its efficacy and safety profile beyond six years, making it a reliable option for long-term cholesterol management[1][3][5].

Market Need and Unmet Clinical Needs

Despite the availability of statins, many high-risk patients do not achieve optimal LDL-C levels. Inclisiran fills this gap by providing an effective and convenient treatment option. In China, for instance, the suboptimal LDL-C control rate among ASCVD patients is as low as 6.8-25.5%, making inclisiran a potentially game-changing therapy[1][4].

Pricing and Cost Considerations

Inclisiran comes with a significant price tag, with a wholesale acquisition cost (WAC) of $3,250 per injection, or $6,500 annually for the twice-yearly dosing regimen. This pricing has raised concerns among healthcare providers and payers, particularly in the US, where cost-efficacy analyses are crucial for reimbursement decisions[4].

Reimbursement and Access

In Europe, particularly in the UK, Novartis has negotiated discounts with health authorities to make inclisiran more accessible. The National Institute for Health and Care Excellence (NICE) has concluded that inclisiran is cost-effective for selected secondary prevention patients at the discounted price. However, in the US, commercial population health agreements with private health systems or payers are not anticipated due to reimbursement issues[4].

Financial Projections and Market Impact

Novartis anticipates significant revenue from inclisiran, despite the initial hurdles. The drug's inclusion in the company's late-stage development pipeline, with submission enabling readouts expected in 2024-2025, indicates a strong financial outlook. The VictORION clinical program, which includes over 30 trials and more than 60,000 patients, further solidifies inclisiran's market potential[2][3].

Adoption and Physician Sentiment

Physicians are optimistic about inclisiran's transformative potential in ASCVD prevention. The convenience of twice-yearly injections and the drug's efficacy in achieving LDL-C targets make it an attractive option. However, the high cost and lack of immediate outcomes data pose challenges to widespread adoption[4].

Competitive Landscape

Inclisiran competes with other LDL-C lowering therapies, including PCSK9 inhibitors. While PCSK9 inhibitors have solid clinical outcomes data, inclisiran's unique mechanism of action and dosing regimen set it apart. The higher cost of inclisiran compared to PCSK9 inhibitors is a point of contention, but its long-term efficacy and safety profile may justify the expense for many patients[4].

Global Reach and Clinical Trials

The VictORION program, which encompasses more than 30 clinical trials across over 50 countries, highlights inclisiran's global reach. Ongoing trials, such as the Phase 3 trial in Chinese and Asian patients, will further establish the drug's safety and efficacy in diverse populations[1][3].

Patient and Healthcare Provider Confidence

The long-term data demonstrating consistent LDL-C reduction with inclisiran has instilled confidence in both patients and healthcare providers. The predictable dosing regimen and minimal adverse events, such as injection site reactions, contribute to its appeal[3][5].

Future Outlook and Challenges

While inclisiran faces challenges related to cost and reimbursement, its long-term efficacy and safety make it a valuable addition to the arsenal against ASCVD. As outcomes data become available, the drug's cost-efficacy profile is likely to improve, enhancing its market position. Novartis's strategic efforts, including the 'buy-and-bill' model, aim to smooth the drug's path to market acceptance[4].

Key Takeaways

• Clinical Efficacy: Inclisiran significantly reduces LDL-C levels with a convenient twice-yearly dosing regimen.
• Market Need: Addresses the unmet need for effective LDL-C management in high-risk patients.
• Pricing and Reimbursement: High cost poses challenges, but discounts and cost-efficacy analyses may improve accessibility.
• Global Reach: Part of a large clinical program with trials in over 50 countries.
• Physician Sentiment: Seen as transformative by physicians despite initial cost concerns.
• Future Outlook: Long-term data and strategic market approaches are expected to enhance its market position.

FAQs

What is inclisiran sodium, and how does it work?

Inclisiran sodium, or Leqvio, is a small interfering RNA (siRNA) therapy that targets PCSK9 to lower LDL-C levels. It works by inhibiting the production of PCSK9, a protein that reduces the number of LDL receptors on the liver, thereby increasing LDL-C levels.

How often is inclisiran administered?

Inclisiran is administered via subcutaneous injection twice yearly.

What are the key benefits of inclisiran?

Inclisiran offers significant LDL-C reduction, a convenient dosing regimen, and long-term efficacy and safety.

Why is inclisiran considered expensive?

The wholesale acquisition cost (WAC) of inclisiran is $3,250 per injection, or $6,500 annually, which is higher than some other LDL-C lowering therapies.

Are there any ongoing clinical trials for inclisiran?

Yes, inclisiran is part of the VictORION clinical program, which includes over 30 trials and more than 60,000 patients worldwide.

Sources

1. The clinical effects of inclisiran, a first-in-class LDL-C lowering ... - Lipid Journal
2. Q4 2022 Results - Investor presentation - Novartis - Novartis
3. Novartis presents new long-term Leqvio® (inclisiran) data ... - Novartis
4. Pricey Inclisiran Is Rolling Out: a 'Buy-and-Bill' Model May Smooth ... - TCTMD
5. Novartis presents new long-term Leqvio® (inclisiran) data ... - Novartis

Last updated: 2024-12-16