Vutrisiran sodium - Generic Drug Details

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

Vutrisiran sodium is the generic ingredient in one branded drug marketed by Alnylam Pharms Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vutrisiran sodium has two hundred and thirty-two patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for vutrisiran sodium

International Patents:	232
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	vutrisiran sodium at DailyMed

Pharmacology for vutrisiran sodium

Drug Class	Small Interfering RNA Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

Anatomical Therapeutic Chemical (ATC) Classes for vutrisiran sodium

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for vutrisiran sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	8,828,956		Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	10,806,791			Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	9,399,775		Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	11,286,486		Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	12,049,628		Y	Y

EU/EMA Drug Approvals for vutrisiran sodium

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Alnylam Netherlands B.V.	Amvuttra	vutrisiran	EMEA/H/C/005852 Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.	Authorised	no	no	yes	2022-09-15

International Patents for vutrisiran sodium

Country	Patent Number	Title	Estimated Expiration
China	104080794	RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases
Japan	2024020209	修飾二本鎖ＲＮＡ剤
Cyprus	1123693
World Intellectual Property Organization (WIPO)	2008131419
New Zealand	624471	Modified rnai agents
Japan	2019131595	トランスサイレチン（ＴＴＲ）関連疾患を治療するためのＲＮＡｉ剤、組成物、およびこれらの使用方法 (RNAi AGENTS, COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING TRANSTHYRETIN (TTR) ASSOCIATED DISEASES)

Supplementary Protection Certificates for vutrisiran sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3329002	CA 2023 00008	Denmark		PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916
3329002	CR 2023 00008	Denmark		PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916
3329002	PA2023505,C3329002	Lithuania		PRODUCT NAME: VUTRISIRANAS; REGISTRATION NO/DATE: EU/1/22/1681 20220915
3329002	PA2023505	Lithuania		PRODUCT NAME: VUTRISIRANAS; REGISTRATION NO/DATE: EU/1/22/1681 20220915
3329002	7/2023	Austria		PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: EU/1/22/1681 (MITTEILUNG) 20220916
3329002	23C1008	France		PRODUCT NAME: VUTRISIRAN DANS TOUTES LES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE; REGISTRATION NO/DATE: EU/1/22/1681 20220916

Vutrisiran sodium Market Analysis and Financial Projection Experimental

Vutrisiran Sodium: Market Dynamics and Financial Trajectory

Introduction to Vutrisiran Sodium

Vutrisiran sodium, developed by Alnylam Pharmaceuticals, is a groundbreaking medication designed to treat hereditary transthyretin-mediated amyloidosis (hATTR), a rare and progressive genetic disease. This drug utilizes RNA interference (RNAi) technology to silence the production of the abnormal transthyretin (TTR) protein responsible for the accumulation of amyloid fibrils in the body[1][3][4].

Market Overview

The global vutrisiran market has shown significant growth since the drug's approval by the United States Food and Drug Administration (FDA) in September 2021 and the European Medicines Agency (EMA) in November 2021. Here are some key market metrics:

• Current Market Value: The global vutrisiran market was valued at approximately $671.96 million in 2023[1][3].
• Projected Market Value: It is expected to reach $2,087 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 12% during the forecast period[1][3][4].

Drivers of Market Growth

Several factors are driving the growth of the vutrisiran market:

High Unmet Medical Need

Hereditary transthyretin-mediated amyloidosis (hATTR) has limited treatment options, making vutrisiran a significant therapeutic advancement. The drug's ability to target the root cause of the disease has generated substantial interest and demand[1][3][4].

Increasing Prevalence of hATTR

Improved diagnosis and increased awareness of hATTR are leading to a growing patient pool. This trend is expected to continue, driving the demand for vutrisiran[1][3].

Regulatory Approvals and Availability

The recent approvals by the FDA and EMA have expanded the availability of vutrisiran to more regions, further boosting its market potential[1][3].

Favorable Reimbursement Policies

Accessible reimbursement policies by insurance companies and government healthcare systems are making vutrisiran more affordable for patients, which is a significant driver of market growth[1].

Restraints and Challenges

Despite the positive outlook, there are several challenges that could impact the market growth of vutrisiran:

Development of Alternative Medications

Other drugs, such as Pfizer's tafamidis, are in development for hATTR. If these alternatives prove effective and gain regulatory approval, they could compete with vutrisiran and potentially reduce its market share[1].

Expensive Nature of the Drug

The high cost of vutrisiran is a significant barrier to access for many patients. This could limit the drug's adoption and impact market growth[4].

Lack of Qualified Personnel

The lack of qualified healthcare professionals to diagnose and treat hATTR could also hamper the market growth of vutrisiran[4].

Financial Performance of Alnylam Pharmaceuticals

Alnylam Pharmaceuticals, the developer of vutrisiran, has seen robust financial performance driven by its commercial medicines, including vutrisiran:

• Net Product Revenues: Alnylam reported $1.24 billion in global net product revenues for 2023, reflecting strong growth across its commercial portfolio[2].
• Revenue Growth: The company's total net product revenues have shown consistent growth, with vutrisiran contributing significantly to this increase[2].

Regional Market Analysis

The vutrisiran market is distributed across various regions, each with its own growth dynamics:

North America

North America is expected to hold a significant market share, approximately 45% in 2023, due to the presence of major manufacturers and a high number of diagnostic procedures in the region[3][4].

Europe

Europe is also a major market, expected to possess around 41% of the market share in 2023. The regulatory approvals in Europe have been instrumental in driving the market growth in this region[3].

Asia Pacific

The Asia Pacific region is expected to register a steady revenue CAGR during the forecast period, driven by the growth in the pharmaceutical business and increasing healthcare spending in the region[4].

Competitive Landscape

The vutrisiran market is characterized by a competitive landscape with several key players:

• Alnylam Pharmaceuticals: The developer of vutrisiran, with a strong pipeline of other RNAi-based therapies[1][3].
• Orphalan, AstraZeneca, Vivet Therapeutics: Other significant players in the market, each with their own portfolio of treatments for rare genetic diseases[1][3].

Patient Access and Support Programs

Alnylam Pharmaceuticals has established patient access programs to ensure that patients who need vutrisiran can access the drug. These programs include financial assistance, support services, and other resources to help patients afford the treatment[3].

Key Segments Profiled

The vutrisiran market can be segmented based on various criteria:

• Drug Class: Includes antisense oligonucleotides, nucleic acids, nucleotides, and nucleosides[3].
• Distribution Channels: Hospital pharmacies are expected to hold a significant market share, approximately 46% in 2023[3].

Clinical Trials and Research

The success of vutrisiran in clinical trials has been a crucial factor in its market growth. Continued research and development in RNAi technology and transthyretin amyloidosis are expected to drive further innovation and growth in the market[1][3][4].

Key Takeaways

• Market Growth: The global vutrisiran market is expected to grow at a CAGR of 12% from 2023 to 2033.
• Drivers: High unmet medical need, increasing prevalence of hATTR, regulatory approvals, and favorable reimbursement policies.
• Challenges: Development of alternative medications, expensive nature of the drug, and lack of qualified personnel.
• Regional Performance: North America and Europe are significant markets, with Asia Pacific showing steady growth.
• Competitive Landscape: Alnylam Pharmaceuticals and other key players are driving the market with their portfolios of RNAi-based therapies.

FAQs

What is vutrisiran used for?

Vutrisiran is used to treat hereditary transthyretin-mediated amyloidosis (hATTR), a rare genetic disease that affects multiple organs and tissues.

Who developed vutrisiran?

Vutrisiran was developed by Alnylam Pharmaceuticals.

What is the expected market value of vutrisiran by 2033?

The global vutrisiran market is expected to reach $2,087 million by 2033.

What are the main drivers of the vutrisiran market growth?

The main drivers include high unmet medical need, increasing prevalence of hATTR, regulatory approvals, and favorable reimbursement policies.

What are the challenges facing the vutrisiran market?

Challenges include the development of alternative medications, the expensive nature of the drug, and the lack of qualified personnel.

Cited Sources

1. Future Market Insights: Vutrisiran Market Analysis, Sales, Size & Forecast 2033.
2. Alnylam Pharmaceuticals: Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results.
3. GlobeNewswire: Global Vutrisiran Market is set to surpass a revenue of US$ 2 Billion by 2033.
4. Reports and Data: Vutrisiran Market Size, Share, Demand and Forecast by 2030.