Pharma Patent Cliffby readouts.io
Loss of exclusivity · Cardiometabolic

Farxiga patent expiration

Farxiga (AstraZeneca) has faced US generic competition since 2026. FDA approved the first US generics on 7 April 2026.

US loss of exclusivity
2026Generics launched
2025 worldwide sales
$8.4BAstraZeneca
Therapeutic area
Cardiometabolic
Medicare negotiated price
−68%From 2026, vs list price
US competition from
GenericsUS date shown

What the date means

Farxiga'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

Farxiga was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 68% below its list price. That is the same year US generics can launch. 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 Farxiga

  1. US copies launched
    FDA approved the first US generics of Farxiga

    Several generic dapagliflozin makers were approved at once, ending US exclusivity. FDA

  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 AstraZeneca

AstraZeneca
27%

Farxiga is 14% of AstraZeneca's 2025 revenue ($8.4B of $58.7B). With Tagrisso, the drugs tracked here add up to 27% of AstraZeneca's revenue losing US exclusivity by 2032.

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

Other blockbusters losing US exclusivity in 2026

Sources

  1. AZ FY2025
  2. FDA
  3. CMS: negotiated prices for 2026
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