Inclisiran Sodium Patent Expiration

Inclisiran Sodium is Used for reducing cholesterol levels in adults with certain genetic disorders or cardiovascular diseases by inhibiting the PCSK9 gene expression in combination with diet and statin therapy. It was first introduced by Novartis Pharmaceuticals Corp in its drug Leqvio on Dec 22, 2021.


Inclisiran Sodium Patents

Given below is the list of patents protecting Inclisiran Sodium, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Leqvio US10851377 Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder Aug 25, 2036 Novartis
Leqvio US10125369 PCSK9 iRNA compositions and methods of use thereof Aug 18, 2034 Novartis
Leqvio US12460206 Pcsk9 Irna Compositions And Methods Of Use Thereof Aug 18, 2034 Novartis
Leqvio US8106022 Carbohydrate conjugates as delivery agents for oligonucleotides Dec 12, 2029 Novartis
Leqvio US10806791 Carbohydrate conjugates as delivery agents for oligonucleotides Dec 04, 2028 Novartis
Leqvio US8828956 Carbohydrate conjugates as delivery agents for oligonucleotides Dec 04, 2028 Novartis
Leqvio US9370582 Carbohydrate conjugates as delivery agents for oligonucleotides Dec 04, 2028 Novartis
Leqvio US10131907 Glycoconjugates of RNA interference agents Aug 24, 2028 Novartis
Leqvio US8222222 Compositions and methods for inhibiting expression of the PCSK9 gene Dec 29, 2027 Novartis
Leqvio US8809292 Compositions and methods for inhibiting expression of the PCSK9 gene May 10, 2027 Novartis
Leqvio US11530408 Therapeutic compositions May 18, 2024

(Expired)

Novartis
Leqvio US10273477 Therapeutic compositions Mar 08, 2024

(Expired)

Novartis
Leqvio US10669544 Therapeutic compositions Mar 08, 2024

(Expired)

Novartis
Leqvio US9708615 Therapeutic compositions Mar 08, 2024

(Expired)

Novartis
Leqvio US9708610 Compositions comprising alternating 2′-modified nucleosides for use in gene modulation Jan 01, 2024

(Expired)

Novartis
Leqvio US10266825 Compositions comprising alternating 2′-modified nucleosides for use in gene modulation Nov 04, 2023

(Expired)

Novartis
Leqvio US11078485 Compositions comprising alternating 2′-modified nucleosides for use in gene modulation Nov 04, 2023

(Expired)

Novartis
Leqvio US8232383 RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA) Feb 20, 2023

(Expired)

Novartis
Leqvio US10590418 Methods and compositions for RNAi mediated inhibition of gene expression in mammals Jul 19, 2022

(Expired)

Novartis
Leqvio US8546143 Compositions and methods for inhibiting expression of a target gene Apr 23, 2022

(Expired)

Novartis
Leqvio US9074213 Compositions and methods for inhibiting expression of a target gene Mar 09, 2022

(Expired)

Novartis



Inclisiran Sodium's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Inclisiran Sodium:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients. Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE3
Phase 2 Clinical Study of MWX203 Injection Alone or in Combination With Inclisiran Sodium Injection in Patients With Mixed Dyslipidemia Shanghai Minwei Biotechnology Co., Ltd NA RECRUITING
(Sep 1, 2026)
PHASE2
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia Novartis Pharmaceuticals NA RECRUITING
(Jul 1, 2026)
PHASE3
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia Novartis Pharmaceuticals NA RECRUITING
(May 1, 2026)
PHASE3
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease University of Oxford NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3


Inclisiran Sodium Generic API Manufacturers

Given below is the list of companies who have filed for Inclisiran Sodium generic, along with the locations of their manufacturing plants worldwide.