When does the patent for Leqvio expire?
DrugPatentWatch.com reports that the primary patent for Leqvio (inclisiran) is scheduled to expire on December 11, 2037. [1]
What other exclusivity periods might Leqvio have?
Beyond the primary patent, Leqvio may benefit from other forms of market exclusivity. For instance, it could be eligible for an additional five years of New Chemical Entity (NCE) exclusivity in the United States after its initial approval, which would extend until 2027 if approved in 2022. Orphan Drug Exclusivity (ODE) and Pediatric Exclusivity are also potential avenues that could add time to market protection. [2]
How does Leqvio's patent situation compare to other cholesterol-lowering drugs?
The patent landscape for Leqvio is distinct from older classes of cholesterol-lowering medications like statins, which have long been off-patent and face significant generic competition. Leqvio, as a novel siRNA therapeutic targeting PCSK9, entered the market much later, with its patent protection extending further into the future compared to many existing treatments. [1]
When can generic or biosimilar versions of Leqvio potentially enter the market?
Generic competition for Leqvio cannot legally enter the market until its patents expire, which is currently set for December 2037. However, the specific timing for generic entry can be influenced by patent litigation and the expiration of other exclusivity periods. [1][2]
What is Leqvio and how does it work?
Leqvio is an injectable medication used to lower low-density lipoprotein cholesterol (LDL-C) in adults. It works by using small interfering RNA (siRNA) to reduce the production of PCSK9 protein in the liver. This reduction in PCSK9 leads to more LDL receptors on the liver surface, which then remove more LDL cholesterol from the blood. [3]
What clinical data supports Leqvio's effectiveness?
Leqvio's efficacy has been demonstrated in clinical trials such as the ORION-9, ORION-10, ORION-11, and ORION-12 studies. These trials showed that Leqvio significantly reduced LDL-C levels when used in conjunction with maximally tolerated statin therapy or as monotherapy for patients who cannot tolerate statins. [3]
What are the main side effects associated with Leqvio?
Common side effects reported for Leqvio include injection site reactions, upper respiratory tract infections, and influenza. [3]
Who developed and markets Leqvio?
Leqvio was developed by Alnylam Pharmaceuticals and is marketed by Novartis. [4]
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Sources:
1. "Leqvio Patent Expiration Date." DrugPatentWatch.com. Accessed [Date of Access].
2. "Drug Exclusivity." U.S. Food and Drug Administration. Accessed [Date of Access].
3. "Leqvio Prescribing Information." Novartis. Accessed [Date of Access].
4. "Alnylam and Novartis Announce FDA Approval of Leqvio (inclisiran) for the Treatment of Hypercholesterolemia." Novartis Press Release. November 29, 2021. Accessed [Date of Access].