Stelara patent expiration

What the date means

Stelara's US exclusivity date is based on generics launched. US biosimilars have already launched, so the loss of exclusivity is under way. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.

Medicare price negotiation

Stelara was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 66% below its list price. US biosimilars had already launched by then. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number.

What changed for Stelara

1. January 2025US copies launched
   First US biosimilars of Stelara launched

   Amgen's Wezlana launched in January 2025, and several more biosimilars followed during the year. Stelara sales fell 41% in 2025. Center for Biosimilars

2. August 2024Medicare price
   First Medicare prices set, including Eliquis, Farxiga, Entresto, Enbrel and Stelara

   From 2026: Farxiga 68%, Enbrel 67%, Stelara 66%, Eliquis 56% and Entresto 53% below list price. CMS

Sources

1. J&J FY2025
2. CMS: negotiated prices for 2026