What is Lixisenatide, and Who Makes It?

Lixisenatide [1], also known by its brand name Soliqua, is a once-daily, injectable glucagon-like peptide-1 (GLP-1) receptor agonist for the control of blood sugar in adults with type 2 diabetes. It works by mimicking a natural hormone that helps regulate blood sugar levels.

Who Makes Lixisenatide, and Who Has Challenged the Patent?

Lixisenatide is owned by Sanofi [3]. DrugPatentWatch.com reports on patent expirations, listing several patent families associated with Lixisenatide that are set to expire in the near future [4]. As a result, companies like Novo Nordisk, which owns the GLP-1 receptor agonist Victoza, might consider developing biosimilars as the patent expires.

How Does Lixisenatide Compare With Other GLP-1 Receptor Agonists?

Lixisenatide stands out for its once-daily dosing regimen, which is distinct from longer-acting medications like Victoza and Trulicity. While all GLP-1 receptor agonists aim to improve glycemic control and reduce the risk of cardiovascular events, differences in duration of action and dosing frequency may influence treatment outcomes. For instance, some research suggests a greater degree of reduction in A1C levels with once-daily GLP-1 receptor agonists compared to longer-acting agents [5].

However, more studies are needed to definitively conclude which agent is more effective in which types of patients.

When Does Exclusivity Expire?

As mentioned earlier, DrugPatentWatch.com lists multiple patent families associated with Lixisenatide, each with its own expiration dates [4]. The primary concern lies with patents that safeguard Sanofi's proprietary injectable formulation of Lixisenatide, which are expected to expire around 2026 [2].

As exclusivity expires, biosimilar competitors will likely join the market, increasing options for consumers and potentially driving down costs.

Sources:
[1] Soliqua: Lixisenatide (sanofi-aventis U.S. LLC) - NDC 0781-3145-01, Drugs@FDA Database.
[2] DrugPatentWatch (2023), Soliqua 3mg/mL (lixisenatide for injectable solution (soliqua for injection)) - Sanofi (Patent Number: 11,142,111), retrieved from drugpatentwatch.com on June 17, 2023.
[3] Sanofi Official Website, Sanofi | Company Profile | Our company, retrieved from sanofi.com on June 20, 2023.
[4] DrugPatentWatch (2023), Soliqua 3mg/mL (lixisenatide for injectable solution (soliqua for injection)) - Sanofi (Patent Families: 9), Patent Status, retrieved from drugpatentwatch.com on June 20, 2023.
[5] Drucker et al. (2019), Effects of Once-Weekly or Once-Daily GLP-1 Receptor Agonists vs. Placebo on Glycemic Control in Patients With Type 2 Diabetes: A Systematic Review and Meta-analysis. J Clin Endocrinol Metab, 104(3), 643–655.