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Last Updated: December 9, 2024

Inclisiran sodium - Generic Drug Details


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What are the generic sources for inclisiran sodium and what is the scope of patent protection?

Inclisiran sodium is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Inclisiran sodium has two hundred and nineteen patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for inclisiran sodium
International Patents:219
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 13
DailyMed Link:inclisiran sodium at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for inclisiran sodium
Generic Entry Date for inclisiran sodium*:
Constraining patent/regulatory exclusivity:
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 inclisiran sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novartis PharmaceuticalsPhase 4
Novartis PharmaceuticalsPhase 2
The TIMI Study GroupPhase 3

See all inclisiran sodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for inclisiran sodium

US Patents and Regulatory Information for inclisiran sodium

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 Y Y ⤷  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 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
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 ⤷  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 inclisiran sodium

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
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 inclisiran sodium

Country Patent Number Title Estimated Expiration
China 108220295 PCSK9 iRNA组合物及其使用方法 (PCSK9 iRNA compositions and methods of use thereof) ⤷  Sign Up
European Patent Office 2835429 Compositions et procédés d'inhibition d'expression du gène PCSK9 (Compositions and methods for inhibiting expression of the PCSK9 gene) ⤷  Sign Up
Japan 5843914 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2017035340 ⤷  Sign Up
Lithuania PA2021510 ⤷  Sign Up
Spain 2702942 ⤷  Sign Up
European Patent Office 1608735 CONJUGUES D'ARNI (IRNA CONJUGATES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for inclisiran sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2929031 C20210012 00398 Estonia ⤷  Sign Up PRODUCT NAME: INKLISIRAAN;REG NO/DATE: EU/1/20/1494 10.12.2020
2929031 132021000000077 Italy ⤷  Sign Up PRODUCT NAME: INCLISIRAN(LEQVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1494, 20201210
2929031 122021000029 Germany ⤷  Sign Up PRODUCT NAME: LNCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201209
2929031 16/2021 Austria ⤷  Sign Up PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 (MITTEILUNG) 20201210
2929031 2021C/520 Belgium ⤷  Sign Up PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210
2929031 LUC00209 Luxembourg ⤷  Sign Up PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210
2929031 PA2021510,C2929031 Lithuania ⤷  Sign Up PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 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.