Pharma Patent Cliffby readouts.io
Loss of exclusivity · Oncology

Perjeta patent expiration

When does Perjeta go off patent?

In the US, biosimilars can launch from 2026. Perjeta is sold by Roche. Roche says its primary US and EU patents expired in Q2 2025 and expects the first biosimilars in 2026. Sales CHF 2.97B, down 13% as patients move to Phesgo, which combines Perjeta and Herceptin in one injection.

US loss of exclusivity
2026Company guidance
2025 worldwide sales
≈$3.6BRoche
Therapeutic area
Oncology
US competition from
BiosimilarsUS date shown

What the date means

Perjeta'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.

Who's lined up to copy Perjeta

Approved, waiting to launch The FDA approved Henlius and Organon's Poherdy as an interchangeable biosimilar in November 2025. Genentech's patent suit was settled in January 2026 on confidential terms, and no US launch has been announced.

Company (product)Stage
Henlius / Organon (Poherdy)FDA-approved Nov 2025; not yet launched

Checked October 2026. Sources: Organon press release · Pearce IP: settlement

Coming up for Perjeta

2026, date not disclosed

Perjeta expected to lose US exclusivity

Company guidance. Roche says its primary US and EU patents expired in Q2 2025 and expects the first biosimilars in 2026. Sales CHF 2.97B, down 13% as patients move to Phesgo, which combines Perjeta and Herceptin in one injection.

See every upcoming date on the patent cliff calendar →

What past cliffs suggest

Among past biologics facing biosimilars: Humira's US sales fell to 65% of their 2022 level in its first full year of biosimilars (2023) and 16% two years later; Stelara's US sales fell to 57% of their 2024 level in its first full year of biosimilars (2025). See how past cliffs played out →

What's at stake for Roche

Perjeta is 4.8% of Roche's 2025 revenue (≈$3.6B of $74.1B). With Xolair, Tecentriq, Ocrevus and Vabysmo, the drugs tracked here add up to 34% of Roche's revenue losing US exclusivity by 2034. Group sales CHF 61.5B, including Diagnostics.

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

Sources

  1. Roche Finance Report 2025
See all 63 drugs on the patent cliff →

Other blockbusters losing US exclusivity in 2026

All drugs going off patent in 2026 →

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Pharma Patent Cliff by readouts.io. "Perjeta patent expiration: US loss of exclusivity 2026." Updated 8 October 2026. https://pharmapatentcliff.com/perjeta

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