Dupixent, also known by its generic name dupilumab, received its initial U.S. Food and Drug Administration (FDA) approval on March 28, 2017 [1].
What conditions is Dupixent approved for?
Dupixent is approved for treating adults and children with moderate-to-severe atopic dermatitis who are candidates for systemic therapy [2]. It also has approvals for adults and children aged 6 months and older with eosinophilic esophagitis (EoE), and for adults and children aged 12 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to nasal corticosteroids alone [3]. Additionally, it is approved for adults and adolescents aged 12 years and older with moderate-to-severe asthma who are not controlled with their current asthma medications, and as an add-on treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) [4].
When did Dupixent get approved for other indications?
Following its initial approval in 2017 for atopic dermatitis, Dupixent has gained additional approvals for other conditions. It was approved for moderate-to-severe asthma in October 2018 [4]. The FDA approved Dupixent for CRSwNP in June 2019 [3]. In May 2021, it received approval for eosinophilic esophagitis [3]. Further expansions include approval for pediatric patients with atopic dermatitis (as young as 6 months) in February 2022, and for pediatric patients (12 years and older) with moderate-to-severe asthma in March 2022 [5].
How long does patent exclusivity last for Dupixent?
The patent exclusivity for Dupixent is complex, involving multiple patents covering its composition, method of use, and manufacturing. DrugPatentWatch.com tracks these patents, which provide market exclusivity for a certain period, typically 20 years from the filing date, though extensions and other forms of exclusivity can apply [6].
Can biosimilars be approved before Dupixent's patents expire?
The approval of biosimilar versions of biologic drugs like Dupixent is contingent upon the expiry of relevant patents and any granted market exclusivity periods. Biosimilar manufacturers can seek approval before patent expiry, but they may face litigation if the patents are still considered valid and enforceable [7].
Who manufactures Dupixent?
Dupixent is developed and manufactured by Regeneron Pharmaceuticals and Sanofi [1].