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 and one Paragraph IV challenge.

The generic ingredient in AMVUTTRA is vutrisiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vutrisiran sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Amvuttra

Amvuttra was eligible for patent challenges on June 13, 2026.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 20, 2032. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AMVUTTRA

US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for AMVUTTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Constraining patent/regulatory exclusivity:

TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS

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

Paragraph IV (Patent) Challenges for AMVUTTRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMVUTTRA	Subcutaneous Solution	vutrisiran sodium	25 mg/0.5 mL	215515	1	2026-06-15

US Patents and Regulatory Information for AMVUTTRA

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

This potential generic entry date is based on TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS.

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

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/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 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:

Australia

Canada

China

European Patent Office

Japan

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
Australia	2008242583
Canada	2685127
World Intellectual Property Organization (WIPO)	2008131419
Argentina	105543
Brazil	112018000542
Canada	2994285

Supplementary Protection Certificates for AMVUTTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3329002	301216	Netherlands		PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: EU/1/22/1681 20220916
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	2023C/507	Belgium		PRODUCT NAME: VUTRISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1681 20220916
3329002	LUC00297	Luxembourg		PRODUCT NAME: VUTRISIRAN SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/22/1681 20220916
3329002	CA 2023 00008	Denmark		PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916

AMVUTTRA (vutrisiran) Market Dynamics and Financial Trajectory: Pricing, Uptake, Exclusivity, and Competitive Pressure

Last updated: June 26, 2026

AMVUTTRA (vutrisiran) is an ALN (N-acetylgalactosamine)–conjugated, RNAi therapeutic for hereditary transthyretin-mediated amyloidosis (hATTR) in adults with polyneuropathy. Revenue trajectory and near-term market dynamics are driven by (1) payer access and site-of-care economics, (2) treatment adherence in chronic dosing, (3) switching from infused competitors, and (4) exclusivity and patent risk around RNAi and formulation. Competitive pressure centers on tafamidis in ATTR cardiomyopathy and polyneuropathy segments, as well as TTR stabilizers and gene-silencing/knockdown entrants that may re-shape payer willingness to cover long-term high-cost therapy.

How much revenue does AMVUTTRA make and what is its financial trajectory?

Answer: The financial trajectory depends on audited company reporting (Ionis/Renal? and/or Alnylam financials, depending on the reporting entity for U.S. commercialization). Without confirmed, current financial figures (annual revenue, quarter-by-quarter sales, segment attribution, and net price), a complete revenue model cannot be stated accurately.

Which business lines track AMVUTTRA sales

• Brand-level or product-level sales reporting for vutrisiran.
• Regional reporting by U.S., EU, and other markets.
• Net-to-gross and reimbursement outcomes (rebates, discounts, patient assistance).

What drives volatility in reported AMVUTTRA revenue

• Timing of new starts vs. churn (discontinuation, death, loss to follow-up).
• Payer step edits and prior authorization denials.
• Patient migration across indications (polyneuropathy stage and cardiac involvement).
• Competitive switching from prior TTR therapies.

What market dynamics shape AMVUTTRA uptake in hATTR polyneuropathy?

Answer: Uptake is primarily governed by payer coverage criteria, neurologist and amyloid specialist prescribing patterns, and infusion versus injection site-of-care differences that alter total cost of treatment.

Coverage criteria and access mechanisms

• Prior authorization tied to confirmed hATTR diagnosis and polyneuropathy staging.
• Evidence requirements: genetic test for TTR mutation and phenotype confirmation.
• Limits or incentives based on baseline severity and treatment history.

Site-of-care and administration economics

• RNAi delivery typically uses a clinic/hospital infusions paradigm early in treatment, which can shift payer preference when compared with competing modalities.
• Under value-based contracting, payers may seek outcomes tied to neuropathy and functional metrics.

Persistence and adherence effects

• Chronic dosing supports compounding revenue once a patient is established.
• Discontinuation risk rises with advanced comorbidity, access denials, and tolerability management.

How does AMVUTTRA pricing work and what is the net price exposure?

Answer: Net price exposure is driven by list price, payer rebates, patient assistance, and contracting outcomes. A quantitative net-price view requires specific list price, payer discount, and contract terms that are not available in the supplied context.

Key pricing components affecting financial outcomes

• Wholesale acquisition cost (WAC) and ASP-based reimbursement dynamics.
• Commercial rebates and Medicare Part D vs. Part B exposure based on billing category.
• Specialty pharmacy vs. medical benefit routing.

What payers focus on in RNAi contracting

• Cost-per-patient-year vs. response categories.
• Outcome-linked reimbursement when available.
• Real-world evidence commitments for continuation therapy.

How does AMVUTTRA compare with competing hATTR therapies on market share drivers?

Answer: Competitive advantage is shaped by mechanism (RNA interference knockdown of TTR), dosing logistics, and payer willingness to cover high-cost therapies versus TTR stabilizers and other modalities.

Competitive set by therapeutic strategy

• TTR stabilizers (class comparator): tafamidis and diflunisal-type considerations where used.
• Gene-silencing and knockdown competitors: other RNAi or antisense programs depending on geography and approvals.
• Supportive and symptom management: analgesics, autonomic neuropathy care, and cardiac symptom management where relevant.

Switching behavior: what triggers patient migration

• Inadequate disease control on TTR stabilizers.
• Treatment novelty and formulary alignment.
• Insurance step therapy that pushes patients toward approved alternatives.

When does AMVUTTRA lose exclusivity and what patent expiry risk exists?

Answer: Exclusivity and patent expiry timing must be mapped from the specific Orange Book entries (U.S.) and parallel patent families across jurisdictions. A complete, accurate exclusivity timeline cannot be produced without the underlying Orange Book/patent listing set for vutrisiran.

What to check in a full exclusivity model

• Composition-of-matter vs. method-of-use vs. formulation patents.
• Pediatric exclusivity and data exclusivity (where applicable).
• Regulatory exclusivity dates tied to FDA approvals and label expansions.

How patent expiry translates into financial exposure

• Probability-weighted generic or biosimilar risk is low for most small-molecule patterns but higher for follow-on biologic-like modalities, depending on regulatory classification and manufacturing/IP barriers.
• Settlement-backed launches can compress peak revenue.

What patents protect AMVUTTRA in the US and Europe, and how strong is the estate?

Answer: The patent estate strength must be derived from patent numbers, assignee structure, remaining term, and any litigation/terminal disclaimers tied to vutrisiran. That dataset is not available in the provided context, so a defensible “strong/weak” assessment cannot be stated.

Common patent clusters in ALN products

• RNAi duplexes and sequence-specific constructs.
• Targeting ligands (GalNAc) and conjugate chemistry.
• Formulation, manufacturing intermediates, and process claims.
• Indications and dosing regimens.

Are there any Paragraph IV challenges or biosimilar risks for AMVUTTRA?

Answer: Paragraph IV challenges are a small-molecule generics construct tied to FDA NDA ANDA. AMVUTTRA’s regulatory and product classification affects applicability. Without specific FDA status and ANDA/505(b)(2) submissions, the existence and timing of challenges cannot be stated.

Biosimilar risk assessment logic

• If classified as a biologic or “biologic-like,” biosimilar pathways apply.
• Even when regulatory pathway exists, manufacturing and IP barriers for RNAi payloads can limit entry.

What is the Orange Book status of AMVUTTRA and what does it mean for generic entry?

Answer: Orange Book listings must be reviewed entry-by-entry (active ingredients, dosage forms, patent numbers, and expiration dates). A complete Orange Book status summary cannot be produced from the current input.

How to translate Orange Book data into entry timing

• Identify earliest expiration by patent listed for each product/dosage form.
• Identify any listed non-expiring patents tied to claims that block approval.
• Overlay FDA exclusivity grants if relevant to the NDA/BLA.

What FDA regulatory milestones and label expansions impact AMVUTTRA revenue?

Answer: Revenue impact depends on approved indications, population expansion, and new dosing or eligibility criteria. Without verified FDA labeling history for vutrisiran, a timeline cannot be stated.

Signals that typically move revenue

• New indication approvals for earlier-stage disease or broader mutation coverage.
• Label expansions tied to combination therapy decisions.
• Realignment of clinical endpoints that improve payer coverage.

What litigation or settlements affect AMVUTTRA competition?

Answer: Patent litigation affects market entry timing and manufacturing/IP workarounds, but the presence, forum, and docket details for vutrisiran cannot be enumerated without the underlying litigation dataset.

What matters for financial impact

• Injunction risk and scope (product, method, or process).
• Settlement terms including “launch at risk” dates.
• Exclusivity carve-outs for specific dosage forms or patient subsets.

How do geographic coverage and reimbursement systems affect AMVUTTRA sales growth?

Answer: Global demand is shaped by HTA coverage decisions, reimbursement ceilings, and national pricing negotiations. A quantified geographic trajectory cannot be produced without country-by-country pricing and reimbursement status.

Where payer behavior varies most

• EU via EMA-aligned access plus country HTA decisions.
• UK via NICE appraisal and managed access.
• Commercial payer systems in major markets that use tendering and formulary controls.

What commercialization strategy drives AMVUTTRA financial performance?

Answer: Revenue trajectory is linked to patient identification, specialist engagement, support services, and contracting discipline that reduces payer friction.

Commercial levers that move net revenue

• Case management programs tied to diagnostic pathways.
• Copay and adherence support to reduce abandonment.
• Specialty pharmacy distribution controls to maintain continuity of supply.

Key Takeaways

• AMVUTTRA’s market dynamics are dominated by chronic payer access, persistence, and competition for eligible hATTR polyneuropathy patients.
• Financial trajectory depends on net pricing, contracting outcomes, and pace of patient starts, not just gross label approvals.
• A precise exclusivity and patent-risk view requires Orange Book/patent-family data and litigation/settlement records for vutrisiran, which are not available in the supplied context.
• Near-term competitive pressure is likely to come from alternative ATTR disease-modifying strategies, with payer step edits and outcomes-based contracting shaping relative share.

FAQs

1. How does payer step therapy affect AMVUTTRA initiation for hATTR polyneuropathy patients?
2. What is the typical total cost of treatment for AMVUTTRA vs infusion-based TTR therapies in managed care?
3. Which factors determine AMVUTTRA persistence and discontinuation in real-world cohorts?
4. How do HTA decisions in the EU and NICE guidance in the UK influence AMVUTTRA uptake?
5. What does an Orange Book patent “expiration” mean for follow-on competition timing in the U.S. for vutrisiran?

References

1. FDA Orange Book. Drug Products Listed in the Orange Book. U.S. Food and Drug Administration. (Access required for vutrisiran-specific entries.)
2. FDA Labeling Database. AMVUTTRA (vutrisiran) Prescribing Information. U.S. Food and Drug Administration. (Access required for labeling history.)
3. Company financial reports for the commercialization entity reporting AMVUTTRA sales. (Access required for product-level revenue data.)

DrugChatter Q&A for AMVUTTRA

Amvuttra ema approval?