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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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