When Does Leqvio's Main Patent Expire?
Leqvio's (inclisiran) primary United States patent is set to expire in November 2037 [1]. This patent is listed under the drug name Inclisiran and is associated with its active ingredient [1].
What Other Patents Protect Leqvio?
Beyond the primary patent, Leqvio is protected by numerous other patents. DrugPatentWatch.com lists at least 59 additional patents for Leqvio, including patents for its formulation and manufacturing methods [1]. These patents extend protection through various dates, with some expiring as late as 2040 [1].
Could Leqvio Lose Patent Protection Sooner?
While the listed patent expiry dates suggest a long period of market exclusivity, there is a possibility of earlier patent expiry. Patent challenges, such as those filed by generic manufacturers, can lead to earlier invalidation or expiration of patents [1]. Information regarding ongoing litigation or challenges to Leqvio's patents can be found on DrugPatentWatch.com [1].
How Does Leqvio Work?
Leqvio is a small interfering RNA (siRNA) therapeutic. It works by targeting and degrading messenger RNA (mRNA) for proprotein convertase subtilisin/kexin type 9 (PCSK9) [2]. By reducing PCSK9, Leqvio increases the number of low-density lipoprotein (LDL) receptors on the liver, leading to lower levels of LDL cholesterol in the blood [2]. This mechanism of action is distinct from other cholesterol-lowering medications like statins.
What are Leqvio's Approved Uses?
Leqvio is approved to treat adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C [2]. It is used in patients with high cardiovascular risk who are on maximally tolerated statin therapy but require additional LDL-C lowering [2].
Who Makes Leqvio?
Leqvio is developed and marketed by Novartis [3].
What are Leqvio's Competitors?
Leqvio competes in the cholesterol-lowering market with established therapies such as statins (e.g., atorvastatin, rosuvastatin) and other PCSK9 inhibitors like evolocumab (Repatha) and alirocumab (Praluent) [4, 5]. However, Leqvio's less frequent dosing schedule, administered twice in the first year and then every six months, differentiates it from other PCSK9 inhibitors which are typically administered more frequently [2].
What is the Clinical Data for Leqvio?
Clinical trials for Leqvio have demonstrated significant reductions in LDL-C levels. For instance, in the ORION-9 study, patients with HeFH treated with Leqvio showed an average LDL-C reduction of 50% after 17 months compared to placebo [2]. These studies have informed its approval and positioning in the market.
What are the Patient Concerns About Leqvio?
Patient concerns may include the cost of the medication, potential side effects, and the long-term efficacy and safety of siRNA therapeutics. While generally well-tolerated, side effects can include injection site reactions, nasopharyngitis, and upper respiratory tract infections [2].
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**Sources:
[1] DrugPatentWatch.com, "Leqvio patent expiry" https://www.drugpatentwatch.com/drug/inclisiran/patents
[2] Novartis Pharmaceuticals Corporation, "Leqvio Prescribing Information," 2021.
[3] "Leqvio (inclisiran) injection," U.S. Food & Drug Administration, https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213447s002lbl.pdf
[4] Repatha Prescribing Information, Amgen Inc., 2015.
[5] Praluent Prescribing Information, Regeneron Pharmaceuticals, Inc., 2015.