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 twenty 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for LEQVIO?
- What are the global sales for LEQVIO?
- What is Average Wholesale Price for LEQVIO?
Summary for LEQVIO
International Patents: | 220 |
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
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 |
---|---|
Monash University | Phase 4 |
Novartis Pharmaceuticals | Phase 4 |
LIB Therapeutics LLC | 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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Subscribe | ⤷ Subscribe |
>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: ⤷ Subscribe
Patent: 7053
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 13355237
Estimated Expiration: ⤷ Subscribe
Patent: 20201441
Estimated Expiration: ⤷ Subscribe
Patent: 22224712
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2015013105
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 92160
Estimated Expiration: ⤷ Subscribe
Chile
Patent: 15001506
Estimated Expiration: ⤷ Subscribe
China
Patent: 4854242
Estimated Expiration: ⤷ Subscribe
Patent: 8220295
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0180126
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 20195
Estimated Expiration: ⤷ Subscribe
Patent: 21017
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 29031
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 7110
Estimated Expiration: ⤷ Subscribe
Patent: 1591075
Estimated Expiration: ⤷ Subscribe
Patent: 2090893
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 29031
Estimated Expiration: ⤷ Subscribe
Patent: 36187
Estimated Expiration: ⤷ Subscribe
Patent: 83209
Estimated Expiration: ⤷ Subscribe
France
Patent: C1021
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 13598
Estimated Expiration: ⤷ Subscribe
Patent: 56621
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 35887
Estimated Expiration: ⤷ Subscribe
Patent: 100021
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 8917
Estimated Expiration: ⤷ Subscribe
Patent: 2159
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 74383
Estimated Expiration: ⤷ Subscribe
Patent: 39335
Estimated Expiration: ⤷ Subscribe
Patent: 16506240
Estimated Expiration: ⤷ Subscribe
Patent: 19103501
Estimated Expiration: ⤷ Subscribe
Patent: 21097680
Estimated Expiration: ⤷ Subscribe
Patent: 23103244
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 929031
Estimated Expiration: ⤷ Subscribe
Patent: 2021510
Estimated Expiration: ⤷ Subscribe
Patent: 29031
Estimated Expiration: ⤷ Subscribe
Luxembourg
Patent: 0209
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 7076
Estimated Expiration: ⤷ Subscribe
Patent: 15007035
Estimated Expiration: ⤷ Subscribe
Patent: 19009283
Estimated Expiration: ⤷ Subscribe
Netherlands
Patent: 1107
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 9013
Estimated Expiration: ⤷ Subscribe
Patent: 9002
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 21024
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 29031
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 29031
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 783
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 29031
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1503829
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 2096014
Estimated Expiration: ⤷ Subscribe
Patent: 150091097
Estimated Expiration: ⤷ Subscribe
Patent: 200035490
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 57608
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Australia | 2003290596 | SUGAR SURROGATE-CONTAINING OLIGOMERIC COMPOUNDS AND COMPOSITIONS FOR USE IN GENE MODULATION | ⤷ Subscribe |
Australia | 2003216265 | ⤷ Subscribe | |
Mexico | 2019009283 | ⤷ Subscribe | |
Austria | 556720 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEQVIO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2929031 | 2021024 | Norway | ⤷ Subscribe | PRODUCT NAME: INKLISIRAN; REG. NO/DATE: EU/1/20/1494 20201215 |
2929031 | 2190017-0 | Sweden | ⤷ Subscribe | PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210 |
2929031 | CA 2021 00016 | Denmark | ⤷ Subscribe | PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210 |
2929031 | PA2021510 | Lithuania | ⤷ Subscribe | PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
LEQVIO Market Analysis and Financial Projection Experimental
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