Pharma Patent Cliffby readouts.io
Loss of exclusivity · Cardiometabolic

Entresto patent expiration

Entresto (Novartis) has faced US generic competition since 2025. US generics entered in Q3 2025.

US loss of exclusivity
2025Generics launched
2025 worldwide sales
$7.7BNovartis
Therapeutic area
Cardiometabolic
Medicare negotiated price
−53%From 2026, vs list price
US competition from
GenericsUS date shown

What the date means

Entresto's US exclusivity date is based on generics launched. US generics have already launched, so the loss of exclusivity is under way. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.

Medicare price negotiation

Entresto was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 53% below its list price. US generics 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 Entresto

  1. US copies launched
    First US generics of Entresto launched

    MSN's generic launched through Novadoz, and Torrent followed two days later. Optum Rx

  2. Medicare 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

What's at stake for Novartis

Novartis
26%

Entresto is 14% of Novartis's 2025 revenue ($7.7B of $54.5B). With Cosentyx, 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. Entresto is highlighted.

Other blockbusters losing US exclusivity in 2025

Sources

  1. Novartis Q4 2025
  2. CMS: negotiated prices for 2026
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