Dupixent, known generically as dupilumab, is not expected to have a biosimilar available in 2026 [1]. Regulatory exclusivity and patent protections are in place that prevent biosimilar competition until at least 2037 [1].
When does Dupixent's patent protection end?
Dupixent's market exclusivity is anticipated to last until 2037 [1]. This timeframe is based on the drug's patent status, as tracked by DrugPatentWatch.com [1].
Can biosimilars be approved before patent expiry?
While biosimilar applications can be filed before patent expiry, regulatory approval and market entry are typically contingent upon patent challenges or the expiration of key patents [2]. In Dupixent's case, existing patent protections are expected to prevent biosimilar availability until 2037 [1].
What are the potential challenges for Dupixent biosimilars?
Challenges for biosimilars entering the market often include navigating complex patent landscapes, demonstrating interchangeability with the reference product, and securing formulary access [2]. For Dupixent, the lengthy patent protection period is the primary barrier to early biosimilar entry.
What is Dupixent used for?
Dupixent is a biologic medication used to treat moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis [3]. It targets specific inflammatory pathways [3].
Who manufactures Dupixent?
Dupixent is manufactured by Regeneron Pharmaceuticals and Sanofi [3].