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Last Updated: April 29, 2024

Vutrisiran sodium - Generic Drug Details

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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 twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for vutrisiran sodium

International Patents:	218
US Patents:	12
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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alnylam Pharms Inc	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for vutrisiran sodium

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for vutrisiran sodium

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Country	Patent Number	Title	Estimated Expiration
Slovenia	3329002		⤷ Try a Trial
European Patent Office	3366775	AGENTS D'ARNI MODIFIÉS (MODIFIED RNAI AGENTS)	⤷ Try a Trial
Japan	2018029599	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)	⤷ Try a Trial
Japan	5519523		⤷ Try a Trial
Japan	2021080299	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)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for vutrisiran sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3329002	C20230004 00401	Estonia	⤷ Try a Trial	PRODUCT NAME: VUTRISIRAAN;REG NO/DATE: EU/1/22/1681 16.09.2022
3329002	CA 2023 00008	Denmark	⤷ Try a Trial	PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916
3329002	2023C/507	Belgium	⤷ Try a Trial	PRODUCT NAME: VUTRISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1681 20220916
3329002	2390008-7	Sweden	⤷ Try a Trial	PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916
3329002	LUC00297	Luxembourg	⤷ Try a Trial	PRODUCT NAME: VUTRISIRAN SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/22/1681 20220916
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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