Pharma Patent Cliffby readouts.io
Loss of exclusivity · Oncology

Darzalex patent expiration

Darzalex (Johnson & Johnson) is expected to face US biosimilar competition from 2029. Core US patents expire 2029. Formulation patents on subcutaneous Darzalex Faspro run longer.

US loss of exclusivity
2029Patent-expiry estimate
2025 worldwide sales
$14.3BJohnson & Johnson
Therapeutic area
Oncology
US competition from
BiosimilarsUS date shown

What the date means

Darzalex's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. 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 Johnson & Johnson

Johnson & Johnson
22%

Darzalex is 15% of Johnson & Johnson's 2025 revenue ($14.3B of $94.2B). With Stelara, the drugs tracked here add up to 22% of Johnson & Johnson's revenue losing US exclusivity by 2029. Total includes MedTech.

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

Other blockbusters losing US exclusivity in 2029

Sources

  1. J&J FY2025
See all 26 drugs on the patent cliff →