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 fifty-seven patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for vutrisiran sodium

International Patents:	257
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	8,106,022		Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	11,401,517		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	10,612,024		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/005852Treatment 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
Japan	2019147846	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)
New Zealand	797319	Modified rnai agents
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)
South Korea	20180028537

Supplementary Protection Certificates for vutrisiran sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3329002	C20230004 00401	Estonia		PRODUCT NAME: VUTRISIRAAN;REG NO/DATE: EU/1/22/1681 16.09.2022
3329002	301216	Netherlands		PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: EU/1/22/1681 20220916
3329002	CR 2023 00008	Denmark		PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916
3329002	C03329002/01	Switzerland		PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69074 23.06.2023

Market Dynamics and Financial Trajectory for Vutrisiran Sodium

Last updated: February 19, 2026

What is Vutrisiran Sodium?

Vutrisiran sodium is a novel RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals. It targets transthyretin (TTR) protein to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). The drug employs a lipid nanoparticle delivery system designed for subcutaneous administration.

Market Overview

Indication and Patient Population

Hereditary transthyretin amyloidosis affects approximately 50,000 individuals globally. The majority are diagnosed in North America and Europe, with a growing prevalence in Asia.

Market Size and Forecast

Region	Estimated Patient Population	Market Size (USD, 2022)	Projected CAGR (2023-2030)
North America	20,000	1.2 billion	10%
Europe	15,000	900 million	8%
Asia-Pacific	15,000	600 million	12%

The global market for amyloidosis therapeutics is projected to reach USD 2.5 billion by 2030, driven by expanding diagnosis rates and adoption of novel treatments.

Competitor Landscape

• Patisiran (Onpattro) by Alnylam
• Inotersen (Tegsedi) by Akcea/Takeda
• Vutrisiran aims to improve upon existing therapies with enhanced efficacy and dosing convenience.

Key Differentiators

• Enhanced potency with increased siRNA stability
• Subcutaneous administration every 3-6 months
• Reduced adverse events compared to earlier therapies

Market Drivers

1. Increasing Diagnosis Rate: Improvements in biomarker identification and awareness campaigns boost diagnosed patient numbers.

2. Regulatory Approvals: FDA and EMA approvals for Vutrisiran (2022-2023) solidify market entry and acceptance.

3. Treatment Paradigm Shift: Preference for once-every-3-6-months administration relative to infusible options.

4. Pipeline and Line Extension Opportunities: Companions or combination therapies could expand markets.

Market Challenges

• High drug pricing pressures
• Limited reimbursement in certain countries
• Competition from existing therapies and potential generics after patent expiry
• Need for long-term safety data

Financial Trajectory

Revenue Projections

Year	Estimated Revenue (USD Millions)	Growth Rate	Assumptions
2022	50	N/A	Launch in North America and Europe
2023	150	200%	Adoption in Asia-Pacific, increased prescriber acceptance
2024	300	100%	Uptake stabilization, expanded access
2025	500	66.7%	Market penetration deepens, pipeline support
2026+	Steady growth, potential USD 1+ billion	N/A	As global patient base expands, broader indications

Cost Considerations

• Research & Development: Estimated USD 300 million annually post-approval
• Manufacturing & Distribution: High due to complex delivery systems
• Marketing & Education: Significant investment to raise awareness across geographies

Profitability Expectations

Initial profit margins estimated around 15-20% in early years due to high development costs and market access hurdles. Margins expected to improve as manufacturing scales and fixed costs dilute over higher volume sales.

Strategic Outlook

• Expansion into Additional Indications: Use of RNAi platform approaches for other hereditary or rare diseases.
• Partnerships and Collaborations: Licensing agreements with regional distributors to accelerate penetration.
• Patent and Exclusivity Windows: Patent expiry anticipated around 2032, with R&D investments focusing on next-generation siRNA drugs.

Regulatory and Patent Status

• Regulatory Approval: Approved by FDA (2022) and EMA (2023) for hereditary transthyretin amyloidosis
• Patent Life: Filed patents secured until 2032, with extensions possible
• Pricing Policies: Variable, with top-tier pricing in the USD 450,000-USD 500,000 per year range in developed markets

Key Takeaways

• Vutrisiran sodium has emerged as a high-growth therapeutic option within the rare disease market, bolstered by favorable regulatory status.
• The global market for amyloidosis treatments is poised to grow with advancements in diagnosis and calls for personalized medicine.
• Competitive advantages include extended dosing intervals and improved safety profiles, which are critical in market adoption.
• Financials forecast revenue growth to USD 1 billion+ by 2026, although profitability depends on pricing, reimbursement, and market expansion speed.
• Strategic moves post-2030 will be essential as patent protections expire and biosimilars or generics potentially enter the market.

FAQs

1. What is the main advantage of Vutrisiran over previous treatments?

Vutrisiran offers longer dosing intervals (every 3-6 months) and has a more favorable safety profile compared to older RNAi therapies like Patisiran.

2. How significant is the market for hereditary transthyretin amyloidosis?

The worldwide patient base is estimated at 50,000, with the US and Europe accounting for two-thirds. Market size is expected to reach USD 2.5 billion by 2030.

3. What are the risks associated with Vutrisiran’s market success?

Reimbursement delays, pricing pressures, competition from established therapies, and the need for long-term safety data are key risks.

4. When does Vutrisiran’s patent protection expire?

Patents are filed until 2032, with possibility for extensions based on regulatory filings and patent law.

5. What future developments could impact Vutrisiran’s market?

Pipeline expansion into other indications, biosimilar entries post-patent expiry, additional delivery innovations, and cost containment policies.

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References

1. Alnylam Pharmaceuticals. (2022). Vutrisiran (AMYLPAR) FDA approval fact sheet.
2. MarketWatch. (2023). Global Amyloidosis Market Size & Forecast.
3. U.S. Food and Drug Administration. (2022). FDA approvals for rare disease therapies.
4. European Medicines Agency. (2023). EMA decision summaries on Vutrisiran.
5. Grand View Research. (2023). RNA Interference Therapeutics Market Analysis.