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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 twelve patents protecting this drug.

This drug has two hundred and eighteen 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:	218
US Patents:	12
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

Anatomical Therapeutic Chemical (ATC) Classes for AMVUTTRA

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

US Patents and Regulatory Information for AMVUTTRA

AMVUTTRA is protected by twelve 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.

Patents protecting AMVUTTRA

FDA Regulatory Exclusivity protecting AMVUTTRA

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

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
European Patent Office	4321177	CONJUGUÉS GLUCIDIQUES UTILISÉS COMME AGENTS D'ADMINISTRATION POUR DES OLIGONUCLÉOTIDES (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)
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)
Serbia	61297	TRANSTIRETINSKE (TTR) KOMPOZICIJE IRNK I POSTUPCI ZA NJIHOVU PRIMENU U LEČENJU ILI PREVENCIJI BOLESTI POVEZANIH SA TTR-OM (TRANSTHYRETIN (TTR) IRNA COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING OR PREVENTING TTR-ASSOCIATED DISEASES)

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	CA 2023 00008	Denmark		PRODUCT NAME: VUTRISIRAN; REG. NO/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