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 twelve patents protecting this drug.
This drug has two hundred and eighteen 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
Summary for AMVUTTRA
International Patents: | 218 |
US Patents: | 12 |
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
Generic Entry Date for AMVUTTRA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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 |
Anatomical Therapeutic Chemical (ATC) Classes for AMVUTTRA
US Patents and Regulatory Information for AMVUTTRA
AMVUTTRA is protected by twelve US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMVUTTRA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Brazil
Patent: 2018000542
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 94285
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 18000198
Estimated Expiration: ⤷ Try a Trial
China
Patent: 8138182
Estimated Expiration: ⤷ Try a Trial
Patent: 6064515
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0202082
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 24545
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 29002
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1890394
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 29002
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 0230006
Estimated Expiration: ⤷ Try a Trial
France
Patent: C1008
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 56494
Estimated Expiration: ⤷ Try a Trial
Patent: 56683
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 51998
Estimated Expiration: ⤷ Try a Trial
Patent: 300007
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6614
Estimated Expiration: ⤷ Try a Trial
Patent: 6476
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 96703
Estimated Expiration: ⤷ Try a Trial
Patent: 17559
Estimated Expiration: ⤷ Try a Trial
Patent: 18523655
Estimated Expiration: ⤷ Try a Trial
Patent: 21167313
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 2023505
Estimated Expiration: ⤷ Try a Trial
Patent: 29002
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 5720
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 18000981
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 335
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1216
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 23007
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 29002
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 29002
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 297
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201912341S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 29002
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1800571
Estimated Expiration: ⤷ Try a Trial
Patent: 1902447
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 180028537
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 42300
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 27963
Estimated Expiration: ⤷ Try a Trial
Patent: 07302
Estimated Expiration: ⤷ Try a Trial
Patent: 1718855
Estimated Expiration: ⤷ Try a Trial
Patent: 2130810
Estimated Expiration: ⤷ Try a Trial
Patent: 2344688
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 6276
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
China | 104080794 | RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases | ⤷ Try a Trial |
Lithuania | 3329002 | ⤷ Try a Trial | |
Brazil | 112018000542 | composições de irna de transtirretina (ttr) e métodos de uso das mesmas para o tratamento ou prevenção de doenças associadas à ttr | ⤷ Try a Trial |
South Korea | 20140092921 | RNAI AGENTS, COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING TRANSTHYRETIN (TTR) ASSOCIATED DISEASES | ⤷ Try a Trial |
Taiwan | 202130810 | Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases | ⤷ Try a Trial |
Canada | 2994285 | COMPOSITIONS D'ARNI DE TRANSTHYRETINE (TTR) ET PROCEDES POUR LES UTILISER POUR LE TRAITEMENT OU LA PREVENTION DE MALADIES ASSOCIEES A TTR (TRANSTHYRETIN (TTR) IRNA COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING OR PREVENTING TTR-ASSOCIATED DISEASES) | ⤷ Try a Trial |
Malaysia | 167390 | RNAI AGENTS, COMPOSITIONS AND METHODS OF USE THEREOF FOR TREATING TRANSTHYRETIN (TTR) ASSOCIATED DISEASES | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMVUTTRA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3329002 | C03329002/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VUTRISIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69074 23.06.2023 |
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 |
3329002 | C202330008 | Spain | ⤷ Try a Trial | 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 | 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 | PA2023505 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VUTRISIRANAS; REGISTRATION NO/DATE: EU/1/22/1681 20220915 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |