AMVUTTRA Drug Patent Profile
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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 thirteen patents protecting this drug.
This drug has two hundred and thirty-two 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
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Summary for AMVUTTRA
| International Patents: | 232 |
| US Patents: | 13 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMVUTTRA
*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 |
US Patents and Regulatory Information for AMVUTTRA
AMVUTTRA is protected by thirteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMVUTTRA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
Glycoconjugates of RNA interference agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Modified double-stranded RNA agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Modified double-stranded RNA agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
FDA Regulatory Exclusivity protecting AMVUTTRA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: ⤷ Sign Up
| 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 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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
Patent: 5543
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2018000542
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 94285
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 18000198
Estimated Expiration: ⤷ Sign Up
China
Patent: 8138182
Estimated Expiration: ⤷ Sign Up
Patent: 6064515
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0202082
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 24545
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 29002
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1890394
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 29002
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 0230006
Estimated Expiration: ⤷ Sign Up
France
Patent: C1008
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 56494
Estimated Expiration: ⤷ Sign Up
Patent: 56683
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 51998
Estimated Expiration: ⤷ Sign Up
Patent: 300007
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6614
Estimated Expiration: ⤷ Sign Up
Patent: 6476
Estimated Expiration: ⤷ Sign Up
Patent: 3082
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 96703
Estimated Expiration: ⤷ Sign Up
Patent: 17559
Estimated Expiration: ⤷ Sign Up
Patent: 18523655
Estimated Expiration: ⤷ Sign Up
Patent: 21167313
Estimated Expiration: ⤷ Sign Up
Patent: 24028749
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 2023505
Estimated Expiration: ⤷ Sign Up
Patent: 29002
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 5720
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 18000981
Estimated Expiration: ⤷ Sign Up
Patent: 23012080
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 335
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1216
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 23007
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 29002
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 29002
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 297
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201912341S
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 29002
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1800571
Estimated Expiration: ⤷ Sign Up
Patent: 1902447
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2667020
Estimated Expiration: ⤷ Sign Up
Patent: 180028537
Estimated Expiration: ⤷ Sign Up
Patent: 240074895
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 42300
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 27963
Estimated Expiration: ⤷ Sign Up
Patent: 07302
Estimated Expiration: ⤷ Sign Up
Patent: 1718855
Estimated Expiration: ⤷ Sign Up
Patent: 2130810
Estimated Expiration: ⤷ Sign Up
Patent: 2344688
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 6276
Estimated Expiration: ⤷ Sign Up
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 | 3913056 | AGENTS D'ARNI, COMPOSITIONS ET PROCÉDÉS D'UTILISATION CORRESPONDANTS POUR TRAITER DES MALADIES ASSOCIÉES À LA TRANSTHYRÉTINE (TTR) (RNAI AGENTS, COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING TRANSTHYRETIN (TTR) ASSOCIATED DISEASES) | ⤷ Sign Up |
| Mexico | 2017002144 | ⤷ Sign Up | |
| Japan | 5519523 | ⤷ Sign Up | |
| Japan | 2021073183 | 修飾二本鎖ＲＮＡ剤 (MODIFIED DOUBLE-STRANDED RNA AGENTS) | ⤷ Sign Up |
| Mexico | 2014005971 | AGENTES DE IARN MODIFICADOS. (MODIFIED RNAI AGENTS.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMVUTTRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | C20230004 00401 | Estonia | ⤷ Sign Up | PRODUCT NAME: VUTRISIRAAN;REG NO/DATE: EU/1/22/1681 16.09.2022 |
| 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 | CR 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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