Last Updated: August 11, 2026

Details for Patent: 10,125,369


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Which drugs does patent 10,125,369 protect, and when does it expire?

Patent 10,125,369 protects LEQVIO and is included in one NDA.

This patent has fifty-nine patent family members in thirty-one countries.

Summary for Patent: 10,125,369
Title:PCSK9 iRNA compositions and methods of use thereof
Abstract:The invention relates to RNAi agents, e.g., double-stranded RNAi agents, targeting the PCSK9 gene, and methods of using such RNAi agents to inhibit expression of PCSK9 and methods of treating subjects having a lipid disorder, such as a hyperlipidemia.
Inventor(s):Anna Borodovsky, Kallanthottathil G. Rajeev, Kevin Fitzgerald, Maria Frank-Kamenetsky, William Querbes, Martin Maier, Klaus Charisse, Satyanarayana KUCHIMANCHI, Muthiah Manoharan, Stuart Milstein
Assignee: Alnylam Pharmaceuticals Inc
Application Number:US14/650,128
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,125,369
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;

Drugs Protected by US Patent 10,125,369

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 RX Yes Yes 10,125,369 ⤷  Start Trial Y Y AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE ⤷  Start Trial
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 RX Yes Yes 10,125,369 ⤷  Start Trial Y Y AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE ⤷  Start Trial
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 RX Yes Yes 10,125,369 ⤷  Start Trial Y Y AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,125,369

PCT Information
PCT FiledDecember 05, 2013PCT Application Number:PCT/US2013/073349
PCT Publication Date:June 12, 2014PCT Publication Number: WO2014/089313

International Family Members for US Patent 10,125,369

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2929031 ⤷  Start Trial 301107 Netherlands ⤷  Start Trial
European Patent Office 2929031 ⤷  Start Trial PA2021510 Lithuania ⤷  Start Trial
European Patent Office 2929031 ⤷  Start Trial 2021C/520 Belgium ⤷  Start Trial
European Patent Office 2929031 ⤷  Start Trial 16/2021 Austria ⤷  Start Trial
European Patent Office 2929031 ⤷  Start Trial LUC00209 Luxembourg ⤷  Start Trial
European Patent Office 2929031 ⤷  Start Trial CA 2021 00016 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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