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 |
Anatomical Therapeutic Chemical (ATC) Classes for vutrisiran sodium
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 | 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 | ||
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 |
---|---|---|---|
Taiwan | 202344688 | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases | ⤷ Sign Up |
Japan | 2018007657 | トランスサイレチン(TTR)関連疾患を治療するためのRNAi剤、組成物、およびこれらの使用方法 (RNAI AGENT, COMPOSITION, AND METHOD FOR USING THE SAME FOR TREATING TRANSTHYRETIN (TTR) ASSOCIATED DISEASES) | ⤷ Sign Up |
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) | ⤷ Sign Up |
Eurasian Patent Organization | 201790420 | СРЕДСТВА, ПРЕДСТАВЛЯЮЩИЕ СОБОЙ МОДИФИЦИРОВАННУЮ ДВУХНИТЕВУЮ РНК | ⤷ Sign Up |
South Korea | 102534909 | ⤷ 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 | LUC00297 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/22/1681 20220916 |
3329002 | PA2023505 | Lithuania | ⤷ Sign Up | PRODUCT NAME: VUTRISIRANAS; REGISTRATION NO/DATE: EU/1/22/1681 20220915 |
3329002 | 2390008-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; REG. NO/DATE: EU/1/22/1681 20220916 |
3329002 | 7/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: EU/1/22/1681 (MITTEILUNG) 20220916 |
3329002 | 122023000011 | Germany | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: EU/1/22/1681 20220915 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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