Dupixent Patent Protection
0 patents · Regeneron Pharmaceuticals Inc., Sanofi
Biosimilar Pathway
Dupixent (dupilumab) is a biologic, not a small-molecule drug. Biologics are not listed in the FDA Orange Book and do not face conventional “generic” competition. Instead, follow-on competitors called biosimilars can be approved through the FDA’s BPCIA pathway, typically after the reference product’s 12-year exclusivity period and the resolution of any patent litigation.
For the current biosimilar approvals and exclusivity status of Dupixent, see the authoritative FDA Purple Book listing for dupilumab.
Related Drug Patent Expirations
0 patents · Regeneron Pharmaceuticals Inc.
0 patents · Genentech Inc.
9 patents · earliest expires 2033 · Gilead Sciences Inc.
0 patents · Novartis AG
0 patents · Janssen Biotech Inc.
2 patents · earliest expires 2027 · Bristol-Myers Squibb Company
The Dupixent record above pulls directly from the FDA Orange Book and USPTO patent records. What follows is the per-entity context — how Dupixent sits in the broader U.S. pharmaceutical patent expirations distribution and which underlying factors drive the headline numbers.
The methodology behind every numeric value on this page is publicly documented on the the FDA Orange Book and USPTO patent records portal and described in detail on this site’s methodology page. Refresh cadence varies by underlying series; the page surfaces the as-of date for each number so readers can trace any figure back to the source release.
For readers using this page as a decision input, the related-entity pages elsewhere on the site provide the comparison set. The most useful comparison for Dupixent is typically a peer within U.S. brand-name drugs with similar size, similar exposure, or similar geography — not the national-level summary alone.