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 twenty-one patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for VUTRISIRAN SODIUM
International Patents: | 221 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Alnylam Pharms Inc | AMVUTTRA | vutrisiran sodium | SOLUTION;SUBCUTANEOUS | 215515-001 | Jun 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2018012038 | AGENTES DE IARN MODIFICADOS. (MODIFIED RNAI AGENTS.) | ⤷ Sign Up |
Israel | 256614 | תכשירים של טרנסטירתין (ttr) irna ושיטות לשימוש בהם לטיפול או מניעה של מחלות הקשורות ל-ttr (Transthyretin (ttr) irna compositions and methods of use thereof for treating or preventing ttr-associated diseases) | ⤷ Sign Up |
Japan | 2021167313 | TTR関連疾患を治療または予防するためのトランスサイレチン(TTR)iRNA組成物およびその使用方法 (TRANSTHYRETIN (TTR) iRNA COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING OR PREVENTING TTR-ASSOCIATED DISEASES) | ⤷ Sign Up |
Lithuania | PA2023505 | ⤷ Sign Up | |
Israel | 293434 | גורמי rnai, תכשירים ושיטות לשימוש בהם לטיפול במחלות הקשורות לטרנסתיראתין (Rnai agents, compositions and methods of use thereof for treating transthyretin (ttr) associated diseases) | ⤷ Sign Up |
Serbia | 60414 | AGENSI RNKI, KOMPOZICIJE I POSTUPCI ZA NJIHOVU PRIMENU U LEČENJU BOLESTI POVEZANIH SA TRANSTIRETINOM (TTR) (RNAI AGENTS, COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING TRANSTHYRETIN (TTR) ASSOCIATED DISEASES) | ⤷ Sign Up |
South Korea | 20210068624 | 트랜스티레틴(TTR) 관련 질병을 치료하기 위한 RNAi 제제, 조성 및 그의 사용방법 (RNAi AGENTS COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING TRANSTHYRETIN TTR ASSOCIATED DISEASES) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VUTRISIRAN SODIUM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3329002 | C202330008 | Spain | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/22/1681; DATE OF AUTHORISATION: 20220915; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1681; DATE OF FIRST AUTHORISATION IN EEA: 20220915 |
3329002 | 23C1008 | France | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN DANS TOUTES LES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE; REGISTRATION NO/DATE: EU/1/22/1681 20220916 |
3329002 | 2023C/507 | Belgium | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1681 20220916 |
3329002 | C20230004 00401 | Estonia | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAAN;REG NO/DATE: EU/1/22/1681 16.09.2022 |
3329002 | 122023000011 | Germany | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: EU/1/22/1681 20220915 |
3329002 | 301216 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: EU/1/22/1681 20220916 |
3329002 | CA 2023 00008 | Denmark | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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