Pharma Patent Cliffby readouts.io
Loss of exclusivity · Immunology

Cosentyx patent expiration

Cosentyx (Novartis) is expected to face US biosimilar competition from 2029. Key exclusivities expected to end around 2029.

US loss of exclusivity
2029Patent-expiry estimate
2025 worldwide sales
$6.7BNovartis
Therapeutic area
Immunology
Medicare negotiated price
PendingTakes effect 2028
US competition from
BiosimilarsUS date shown

What the date means

Cosentyx'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.

Medicare price negotiation

Cosentyx was selected for the Medicare Drug Price Negotiation Program. CMS is negotiating its Medicare price now; the price takes effect in 2028 and is due to be published by 30 November 2026. That is 1 year before US biosimilars can launch, so Medicare revenue comes under pressure first. For the 25 drugs negotiated so far, Medicare prices came in 38% to 85% below list price. Those discounts are measured before the rebates drugmakers already pay and apply to Medicare only.

What changed for Cosentyx

  1. Medicare price
    Trulicity, Biktarvy, Cosentyx and Entyvio selected for Medicare price negotiation

    Negotiated prices take effect in 2028. CMS must publish them by 30 November 2026. CMS

What's at stake for Novartis

Novartis
26%

Cosentyx is 12% of Novartis's 2025 revenue ($6.7B of $54.5B). With Entresto, the drugs tracked here add up to 26% of Novartis's revenue losing US exclusivity by 2029.

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

Other blockbusters losing US exclusivity in 2029

Sources

  1. Novartis Q4 2025
  2. CMS: drugs selected for 2028
See all 26 drugs on the patent cliff →