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 eighteen 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
Summary for LEQVIO
| International Patents: | 218 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| 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
Generic Entry Date for LEQVIO*:
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.
Recent Clinical Trials for LEQVIO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| LIB Therapeutics LLC | Phase 3 |
| Medpace, Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for LEQVIO
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 ⤷ 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 LEQVIO
PCSK9 iRNA compositions and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Therapeutic compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting LEQVIO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Patent: 7053
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 13355237
Estimated Expiration: ⤷ Try a Trial
Patent: 20201441
Estimated Expiration: ⤷ Try a Trial
Patent: 22224712
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015013105
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 92160
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 15001506
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4854242
Estimated Expiration: ⤷ Try a Trial
Patent: 8220295
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0180126
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20195
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 29031
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7110
Estimated Expiration: ⤷ Try a Trial
Patent: 1591075
Estimated Expiration: ⤷ Try a Trial
Patent: 2090893
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 29031
Estimated Expiration: ⤷ Try a Trial
Patent: 36187
Estimated Expiration: ⤷ Try a Trial
Patent: 83209
Estimated Expiration: ⤷ Try a Trial
France
Patent: C1021
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 13598
Estimated Expiration: ⤷ Try a Trial
Patent: 56621
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 35887
Estimated Expiration: ⤷ Try a Trial
Patent: 100021
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8917
Estimated Expiration: ⤷ Try a Trial
Patent: 2159
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 74383
Estimated Expiration: ⤷ Try a Trial
Patent: 39335
Estimated Expiration: ⤷ Try a Trial
Patent: 16506240
Estimated Expiration: ⤷ Try a Trial
Patent: 19103501
Estimated Expiration: ⤷ Try a Trial
Patent: 21097680
Estimated Expiration: ⤷ Try a Trial
Patent: 23103244
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 929031
Estimated Expiration: ⤷ Try a Trial
Patent: 2021510
Estimated Expiration: ⤷ Try a Trial
Patent: 29031
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 0209
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 7076
Estimated Expiration: ⤷ Try a Trial
Patent: 15007035
Estimated Expiration: ⤷ Try a Trial
Patent: 19009283
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1107
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9013
Estimated Expiration: ⤷ Try a Trial
Patent: 9002
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 21024
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 29031
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 29031
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 783
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 29031
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1503829
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2096014
Estimated Expiration: ⤷ Try a Trial
Patent: 150091097
Estimated Expiration: ⤷ Try a Trial
Patent: 200035490
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 57608
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 LEQVIO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1109056 | ⤷ Try a Trial | |
| Australia | 2004320622 | Chimeric gapped oligomeric compositions | ⤷ Try a Trial |
| Australia | 2003216255 | ⤷ Try a Trial | |
| Australia | 2003217550 | ⤷ Try a Trial | |
| Denmark | 2287305 | ⤷ Try a Trial | |
| European Patent Office | 0746614 | ⤷ Try a Trial | |
| European Patent Office | 1765074 | PRODUITS DE SYNTHESE D'ARNsi MODIFIES EN POSITION (POSITIONALLY MODIFIED siRNA CONSTRUCTS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEQVIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2929031 | C02929031/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67836 09.09.2021 |
| 2929031 | LUC00209 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210 |
| 2929031 | 2190017-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210 |
| 2929031 | 301107 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210 |
| 2929031 | 2021C/520 | Belgium | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210 |
| 2929031 | C202130028 | Spain | ⤷ Try a Trial | 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 |
| 2929031 | 16/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 (MITTEILUNG) 20201210 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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