Pharsight

Leqvio is owned by Novartis.

Leqvio contains Inclisiran Sodium.

Leqvio has a total of 20 drug patents out of which 4 drug patents have expired.

Expired drug patents of Leqvio are:

US10590418
US9074213
US8546143
US8232383

Leqvio was authorised for market use on 22 December, 2021.

Leqvio is available in solution;subcutaneous dosage forms.

Leqvio can be used as as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (hefh) or clinical atherosclerotic cardiovascular disease (ascvd), by inhibiting expression of the pcsk9 gene.

Drug patent challenges can be filed against Leqvio from 2025-12-22.

The generics of Leqvio are possible to be released after 25 August, 2036.

Application	Filing Date	Opposition Party	Legal Status
EP06025389A	2017-12-15	Silence Therapeutics GmbH	Revoked
EP10011217A	2017-04-13	Silence Therapeutics GmbH	Opposition rejected
EP10008929A	2015-10-06	Quark Pharmaceuticals, Inc.	Patent maintained as amended
EP10008931A	2013-07-26	Alnylam Pharmaceuticals Inc.	Opposition procedure closed
EP03716126A	2013-07-16	Alnylam Pharmaceuticals Inc.	Opposition procedure closed
EP10008930A	2013-05-22	Quark Pharmaceuticals, Inc.	Patent maintained as amended
EP10008930A	2013-05-21	Alnylam Pharmaceuticals Inc.	Patent maintained as amended
EP03743684A	2011-06-01	Alcon Research, Ltd.	Patent maintained as amended
EP03743684A	2011-05-31	Alnylam Pharmaceuticals Inc.	Patent maintained as amended
EP03743684A	2011-05-31	Dharmacon, Inc.	Patent maintained as amended
EP03743684A	2011-05-26	Novartis AG	Patent maintained as amended
EP03743684A	2011-05-18	Sanofi-Aventis Deutschland GmbH	Patent maintained as amended
EP02702247A	2010-12-10	Silence Therapeutics AG	Revoked
EP02702247A	2010-12-10	Sirna Therapeutics	Revoked
EP05002454A	2009-09-24	Silence Therapeutics AG	Granted and Under Opposition
EP05002454A	2009-09-24	ROQUES, Sarah Elizabeth	Granted and Under Opposition
EP05002454A	2009-09-23	PFIZER LIMITED	Granted and Under Opposition
EP05002454A	2009-09-23	Sanofi-Aventis Deutschland GmbH	Granted and Under Opposition
EP05002454A	2009-09-21	Sirna Therapeutics	Granted and Under Opposition
EP02710786A	2007-02-28	Sirna Therapeutics	Opposition rejected
EP02003683A	2006-03-08	atugen AG	Patent maintained as amended
EP02003683A	2006-03-08	Abbott Laboratories	Patent maintained as amended
EP02003683A	2006-03-07	Sirna Therapeutics, Inc.	Patent maintained as amended
EP02003683A	2006-03-07	Quark Biotech, Inc.	Patent maintained as amended
EP00910510A	2003-05-28	atugen AG	Revoked
EP00910510A	2003-05-28	Aventis Pharma Deutschland GmbH	Revoked
EP00910510A	2003-05-28	Grund, Martin, Dr.	Revoked
EP00910510A	2003-05-28	JANSSEN PHARMACEUTICA N.V.	Revoked
EP00910510A	2003-05-28	AstraZeneca AB	Revoked
EP00910510A	2003-05-28	Novartis AG	Revoked
EP00910510A	2003-05-28	Isis Pharmaceuticals, Inc.	Revoked
EP00910510A	2003-05-20	Sirna Therapeutics, Inc.	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US10590418	April, 2012	Decision	Mark A. Kay et al

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9074213	NOVARTIS	Compositions and methods for inhibiting expression of a target gene	Mar, 2022 (1 year, 2 months ago)
US8546143	NOVARTIS	Compositions and methods for inhibiting expression of a target gene	Apr, 2022 (1 year, 1 month ago)
US8232383	NOVARTIS	RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA)	Feb, 2023 (3 months ago)
US11078485	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (4 months from now)
US9708610	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Jan, 2024 (6 months from now)
US9708615	NOVARTIS	Therapeutic compositions	Mar, 2024 (9 months from now)
US10669544	NOVARTIS	Therapeutic compositions	Mar, 2024 (9 months from now)
US10273477	NOVARTIS	Therapeutic compositions	Mar, 2024 (9 months from now)
US11530408	NOVARTIS	Therapeutic compositions	May, 2024 (11 months from now)
US8809292	NOVARTIS	Compositions and methods for inhibiting expression of the PCSK9 gene	May, 2027 (3 years from now)
US10131907	NOVARTIS	Glycoconjugates of RNA interference agents	Aug, 2028 (5 years from now)
US8828956	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US9370582	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US10806791	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US8106022	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (6 years from now)
US10125369	NOVARTIS	PCSK9 iRNA compositions and methods of use thereof	Aug, 2034 (11 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10590418	NOVARTIS	Methods and compositions for RNAi mediated inhibition of gene expression in mammals	Jul, 2022 (10 months ago)
US10266825	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (4 months from now)
US8222222	NOVARTIS	Compositions and methods for inhibiting expression of the PCSK9 gene	Dec, 2027 (4 years from now)
US10851377	NOVARTIS	Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder	Aug, 2036 (13 years from now)

Do you want to check out LEQVIO patents from before 2022?

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Dec 22, 2026

Drugs and Companies using INCLISIRAN SODIUM ingredient

NCE-1 date: 2025-12-22

Market Authorisation Date: 22 December, 2021

Treatment: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (hefh) or clinical atherosclerotic cardiovascular disease (ascv...

Dosage: SOLUTION;SUBCUTANEOUS