LEQVIO Drug Patent Profile
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Which patents cover Leqvio, and what generic alternatives are available?
Leqvio is a drug marketed by Novartis and is included in one NDA. There are thirteen patents protecting this drug.
This drug has two hundred and nineteen patent family members in thirty-three countries.
The generic ingredient in LEQVIO is inclisiran sodium. One supplier is listed for this compound. Additional details are available on the inclisiran sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Leqvio
Leqvio will be eligible for patent challenges on December 22, 2025. 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 August 18, 2034. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for LEQVIO
| International Patents: | 219 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for LEQVIO |
| What excipients (inactive ingredients) are in LEQVIO? | LEQVIO excipients list |
| DailyMed Link: | LEQVIO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEQVIO
*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.
Recent Clinical Trials for LEQVIO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis Pharmaceuticals | Phase 4 |
| Monash University | Phase 4 |
| Medpace, Inc. | Phase 3 |
US Patents and Regulatory Information for LEQVIO
LEQVIO is protected by thirteen US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LEQVIO 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 LEQVIO
PCSK9 iRNA compositions and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Glycoconjugates of RNA interference agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Therapeutic compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Therapeutic compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Compositions and methods for inhibiting expression of the PCSK9 gene
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Compositions and methods for inhibiting expression of the PCSK9 gene
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Therapeutic compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting LEQVIO
NEW CHEMICAL ENTITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 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 |
Expired US Patents for LEQVIO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEQVIO
When does loss-of-exclusivity occur for LEQVIO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3835
Patent: COMPOSICIONES DE ARNi PARA PCSK9 Y METODOS PARA USARLAS
Estimated Expiration: ⤷ Sign Up
Patent: 7053
Patent: COMPOSICIONES DE ARNI PARA PCSK9 Y MÉTODOS PARA USARLAS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 13355237
Patent: PCSK9 iRNA compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Patent: 20201441
Patent: PCSK9 iRNA compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Patent: 22224712
Patent: PCSK9 iRNA compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015013105
Patent: composições de irna de pcsk9 e métodos de uso das mesmas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 92160
Patent: COMPOSITIONS D'ARNI DE PCSK9 ET METHODES D'UTILISATION ASSOCIEES (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 15001506
Patent: Composiciones de arni de pcsk9 y métodos de usos de las mismas
Estimated Expiration: ⤷ Sign Up
China
Patent: 4854242
Patent: PCSK9 iRNA compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Patent: 8220295
Patent: PCSK9 iRNA组合物及其使用方法 (PCSK9 iRNA compositions and methods of use thereof)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0180126
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20195
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 29031
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7110
Patent: КОМПОЗИЦИИ С иРНК К PCSK9 И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 1591075
Patent: КОМПОЗИЦИИ С иРНК К PCSK9 И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
Patent: 2090893
Patent: КОМПОЗИЦИИ С иРНК К PCSK9 И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 29031
Patent: COMPOSITIONS D'ARNI DE PCSK9 ET MÉTHODES D'UTILISATION ASSOCIÉES (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 36187
Patent: COMPOSITIONS D'ARNI PCSK9 ET LEURS PROCÉDÉS D'UTILISATION (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 83209
Patent: COMPOSITIONS D'ARNI PCSK9 ET LEURS PROCÉDÉS D'UTILISATION (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1021
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 13598
Patent: 組合物及其使用方法 (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF PCSK9 IRNA)
Estimated Expiration: ⤷ Sign Up
Patent: 56621
Patent: PCSK9 IRNA組合物及其使用方法 (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 35887
Estimated Expiration: ⤷ Sign Up
Patent: 100021
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8917
Patent: תכשירים של irna ושיטות לשימוש בהם (Pcsk9 irna compositions and methods of use thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 2159
Patent: תכשירים של pcsk9 irna ושיטות לשימוש בהם (Pcsk9 irna compositions and methods of use thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 74383
Estimated Expiration: ⤷ Sign Up
Patent: 39335
Estimated Expiration: ⤷ Sign Up
Patent: 16506240
Patent: ＰＣＳＫ９ｉＲＮＡ組成物及びその使用方法
Estimated Expiration: ⤷ Sign Up
Patent: 19103501
Patent: ＰＣＳＫ９ ｉＲＮＡ組成物及びその使用方法 (PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 21097680
Patent: ＰＣＳＫ９ ｉＲＮＡ組成物及びその使用方法 (PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 23103244
Patent: ＰＣＳＫ９ ｉＲＮＡ組成物及びその使用方法 (PCSK9 iRNA COMPOSITIONS AND METHODS FOR USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 929031
Estimated Expiration: ⤷ Sign Up
Patent: 2021510
Estimated Expiration: ⤷ Sign Up
Patent: 29031
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0209
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 7076
Patent: COMPOSICIONES DE ARNI DE PROTEINA CONVERTASA SUBTILISINA KEXINA 9 (PCSK9) Y METODOS DE USO DE LAS MISMAS. (PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 15007035
Patent: COMPOSICIONES DE ARNI DE PROTEINA CONVERTASA SUBTILISINA KEXINA 9 (PCSK9) Y METODOS DE USO DE LAS MISMAS. (PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 19009283
Patent: COMPOSICIONES DE ARNI DE PROTEINA CONVERTASA SUBTILISINA KEXINA 9 (PCSK9) Y METODOS DE USO DE LAS MISMAS. (PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF.)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1107
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9013
Patent: Pcsk9 irna compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Patent: 9002
Patent: Pcsk9 irna compositions and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 21024
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 29031
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 29031
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 783
Patent: SASTAVI PCSK9 IRNK I POSTUPCI NJIHOVIH PRIMENA (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 29031
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1503829
Patent: PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2096014
Estimated Expiration: ⤷ Sign Up
Patent: 150091097
Patent: PCSK9 iRNA 조성물 및 그 사용 방법 (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 200035490
Patent: PCSK9 iRNA 조성물 및 그 사용 방법 (PCSK9 iRNA PCSK9 iRNA COMPOSITIONS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 57608
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 LEQVIO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1120292 | ⤷ Sign Up | |
| European Patent Office | 1436314 | ⤷ Sign Up | |
| Japan | 2001511003 | ⤷ Sign Up | |
| Japan | 2022190116 | 標的化脂質 | ⤷ Sign Up |
| Japan | 4948163 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEQVIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2929031 | PA2021510 | Lithuania | ⤷ Sign Up | PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209 |
| 2929031 | CA 2021 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210 |
| 2929031 | 2021C/520 | Belgium | ⤷ Sign Up | PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210 |
| 2929031 | 122021000029 | Germany | ⤷ Sign Up | PRODUCT NAME: LNCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201209 |
| 2929031 | C202130028 | Spain | ⤷ Sign Up | PRODUCT NAME: INCLISIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/20/1494; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1494; DATE OF FIRST AUTHORISATION IN EEA: 20201209 |
| >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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