Pharma Patent Cliffby readouts.io
Loss of exclusivity · Immunology

Dupixent patent expiration

Dupixent (Sanofi and Regeneron) is expected to face US biosimilar competition from 2031. Extended US patent runs to 28 March 2031. Sanofi plans to defend exclusivity beyond that.

US loss of exclusivity
2031Company guidance
2025 worldwide sales
$17.8BSanofi and Regeneron
Therapeutic area
Immunology
US competition from
BiosimilarsUS date shown

What the date means

Dupixent's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.

What's at stake for Sanofi and Regeneron

Sanofi
36%

Dupixent is 36% of Sanofi's 2025 revenue (≈$17.8B of $49.3B). Total net sales €43.6B. Sanofi books Dupixent's global sales.

Regeneron
37%

Dupixent is 37% of Regeneron's 2025 revenue ($5.2B of $14.3B). Dupixent is Regeneron's Sanofi collaboration revenue ($5.2B), mostly its share of Dupixent profits.

Bars show each company's tracked drugs as a share of its total 2025 revenue. Dupixent is highlighted.

Nearest patent cliffs to Dupixent

Sources

  1. Regeneron FY2025
  2. Fierce Pharma
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