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AMVUTTRA Drug Patent Profile

When do Amvuttra patents expire, and what generic alternatives are available?

Amvuttra is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has two hundred and thirty-two patent family members in forty-six countries.

The generic ingredient in AMVUTTRA is vutrisiran sodium. One supplier is listed for this compound. Additional details are available on the vutrisiran sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Amvuttra

Amvuttra will be eligible for patent challenges on June 13, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 28, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AMVUTTRA

International Patents:	232
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for AMVUTTRA
What excipients (inactive ingredients) are in AMVUTTRA?	AMVUTTRA excipients list
DailyMed Link:	AMVUTTRA at DailyMed

See drug prices for AMVUTTRA

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

NDA:

215515

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.

Pharmacology for AMVUTTRA

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

US Patents and Regulatory Information for AMVUTTRA

AMVUTTRA is protected by thirteen US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for AMVUTTRA

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 AMVUTTRA

When does loss-of-exclusivity occur for AMVUTTRA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

Netherlands

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AMVUTTRA around the world.

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

Supplementary Protection Certificates for AMVUTTRA

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

AMVUTTRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AMVUTTRA

Introduction to AMVUTTRA

AMVUTTRA, developed by Alnylam Pharmaceuticals, is a groundbreaking RNA interference (RNAi) therapeutic designed to treat transthyretin-mediated amyloidosis (ATTR), including both polyneuropathy and cardiomyopathy (ATTR-CM). Here, we delve into the market dynamics and financial trajectory of this promising drug.

Current Market Performance

AMVUTTRA has shown impressive growth since its launch. In the third quarter of 2024, AMVUTTRA generated $259 million in revenues, marking a 74% year-over-year growth. This strong performance is part of Alnylam's overall TTR franchise success, which drove the company's global net product revenues to $420 million, a 34% increase from the previous year[2].

Financial Outlook

The financial outlook for AMVUTTRA is highly optimistic. Analysts project peak sales of approximately $3.7 billion in the U.S. and $1.8 billion in the European Union for the combined polyneuropathy and ATTR-CM indications. Some projections even suggest peak sales could reach $5 billion to $6 billion, although competition from Pfizer's Vyndamax is expected to continue[1][3].

Revenue Growth Projections

Alnylam's financial trajectory indicates significant revenue growth driven by AMVUTTRA. The company's revenues are expected to grow from $1,828 million in 2023 to $2,908 million in 2025. This growth is largely attributed to the strong commercial performance of AMVUTTRA and the potential expansion of its patient population with the approval for ATTR-CM[3][5].

Cash Position and Financial Health

As of September 30, 2024, Alnylam's cash position stood at $2.78 billion, up from $2.44 billion in December 2023. This strong cash position, combined with a healthy current ratio of 2.75 and an impressive gross profit margin of 85.37%, underscores the company's financial stability and ability to invest in further research and development[2][5].

Competitive Landscape

AMVUTTRA operates in a competitive market, particularly against Pfizer's Vyndamax. However, AMVUTTRA's strong clinical profile, including a 36% reduction in all-cause mortality, sets it apart. The drug's quarterly dosing regimen and novel mechanism of action as an RNAi therapeutic are additional advantages that could lead to guideline updates recommending AMVUTTRA as the preferred initial treatment for ATTR-CM[3].

Challenges and Risks

Despite the promising outlook, Alnylam faces several challenges that could impact AMVUTTRA's commercial success. These include reimbursement hurdles, potential manufacturing and supply chain issues, regulatory delays, and the challenge of convincing physicians to switch from established therapies like tafamidis[3].

Pipeline and Future Growth Opportunities

Beyond AMVUTTRA, Alnylam's pipeline includes several promising candidates that could further drive growth. These include next-generation therapies that could be dosed annually, advanced pipeline programs such as Zilebesiran and ALN-APP, and potential extrahepatic programs. The success of HELIOS-B has heightened expectations for these pipeline assets[3].

Impact on Alnylam's Financial Future

The successful commercialization of AMVUTTRA is crucial for Alnylam's financial future. While the company is currently operating at a loss with negative EPS projected through 2024, the positive HELIOS-B results have reinforced the goal of achieving non-GAAP operating profitability by the end of 2025. The strong uptake of AMVUTTRA and its potential to become a first-line therapy for ATTR-CM are key factors in this financial strategy[3][5].

Clinical and Commercial Success Factors

AMVUTTRA's clinical success, particularly its mortality benefit, is a significant driver of its adoption. The drug's ability to reduce all-cause mortality by 36% provides clear clinical value and differentiates it from existing therapies. The quarterly dosing regimen and potential for combination therapy with tafamidis further enhance its market appeal[3].

Market Expansion and Patient Population

The approval for ATTR-CM could expand AMVUTTRA's patient population significantly. With noninvasive diagnosis techniques becoming more available, the patient population for AMVUTTRA could increase 10-fold, from between 30,000 to 60,000 for polyneuropathy to a much larger population for ATTR-CM[1].

Regulatory Approvals and Submissions

Alnylam has submitted regulatory applications in the U.S. and EU for AMVUTTRA for the treatment of ATTR-CM. The successful outcome of these submissions is critical for the drug's commercial expansion and the company's financial growth[2].

Key Takeaways

• AMVUTTRA has shown strong revenue growth, generating $259 million in Q3 2024.
• Projected peak sales range from $3.7 billion to $6 billion.
• Alnylam's financial trajectory indicates significant revenue growth to $2.908 billion by 2025.
• The company faces challenges such as reimbursement hurdles and market penetration.
• AMVUTTRA's clinical profile, including a 36% reduction in all-cause mortality, is a key driver of its adoption.
• Successful commercialization of AMVUTTRA is crucial for Alnylam's financial future.

FAQs

What is AMVUTTRA and how does it work?

AMVUTTRA is an RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals to treat transthyretin-mediated amyloidosis (ATTR), including polyneuropathy and cardiomyopathy (ATTR-CM). It works by silencing the gene responsible for producing the transthyretin protein, thereby reducing the formation of amyloid deposits.

How has AMVUTTRA performed financially since its launch?

AMVUTTRA has shown significant financial growth, with revenues of $259 million in the third quarter of 2024, representing a 74% year-over-year increase.

What are the projected peak sales for AMVUTTRA?

Analysts project peak sales of approximately $3.7 billion in the U.S. and $1.8 billion in the European Union for the combined polyneuropathy and ATTR-CM indications, with some projections as high as $5 billion to $6 billion.

What challenges does Alnylam face in achieving profitability with AMVUTTRA?

Alnylam faces challenges such as reimbursement hurdles, manufacturing and supply chain issues, regulatory delays, and market penetration challenges in convincing physicians to switch from established therapies.

How does AMVUTTRA differentiate itself from other treatments for ATTR-CM?

AMVUTTRA's strong clinical profile, including a 36% reduction in all-cause mortality, its quarterly dosing regimen, and its novel mechanism of action as an RNAi therapeutic differentiate it from other treatments like tafamidis.

What is the impact of AMVUTTRA on Alnylam's overall financial health?

The successful commercialization of AMVUTTRA is crucial for Alnylam's financial future, aiming to achieve non-GAAP operating profitability by the end of 2025, despite current operating losses.

Cited Sources:

1. Biospace: "Alnylam Could Challenge Pfizer in ATTR-CM But Experts Want Full Data"[1]
2. Stocktitan: "Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results"[2]
3. Investing.com: "Alnylam's SWOT analysis: strong helios-b data bolsters amvuttra stock outlook"[3]
4. Fiercepharma: "Amvuttra makes inroads in ATTR as Alnylam scraps heart disease trial"[4]
5. Investing.com: "Alnylam's SWOT analysis: strong helios-b data bolsters amvuttra stock outlook"[5]