Pharma Patent Cliffby readouts.io
Loss of exclusivity · Cardiometabolic

Vyndaqel patent expiration

Vyndaqel (Pfizer) is expected to face US generic competition from 2028. Pfizer 10-K: US basic patent 2026, with an extension to 2028 pending. Sales are the Vyndaqel family (Vyndaqel and Vyndamax), for a rare heart disease.

US loss of exclusivity
2028Patent-expiry estimate
2025 worldwide sales
$6.4BPfizer
Therapeutic area
Cardiometabolic
US competition from
GenericsUS date shown

What the date means

Vyndaqel'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 small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.

What past cliffs suggest

Among past small-molecule drugs facing generics: Tecfidera's US sales fell to 21% of their 2019 level in its first full year of generics (2021); Revlimid's US sales fell to 96% of their 2021 level in its first full year of generics (2022) and 57% two years later. Where settlements cap generic volumes, as with Revlimid, the decline is slower. See how past cliffs played out →

Who's lined up to copy Vyndaqel

Filed with the FDA Several generic makers filed from June 2023 for both versions (Vyndaqel and Vyndamax). Pfizer and Scripps Research sued in August 2023 over the compound, treatment and crystal-form patents; Pfizer does not name the filers.

Company (product)Stage
Several generic makers (not named by Pfizer)Generics filed; in litigation

Checked September 2026. Sources: Pfizer 10-K 2025

What's at stake for Pfizer

Vyndaqel is 10% of Pfizer's 2025 revenue ($6.4B of $62.6B). With Ibrance, Xtandi, Eliquis and Prevnar 20, the drugs tracked here add up to 43% of Pfizer's revenue losing US exclusivity by 2035. Eliquis and Xtandi are Pfizer's reported alliance and product revenue ($8.0B, $2.2B).

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

Other blockbusters losing US exclusivity in 2028

Sources

  1. Pfizer 10-K 2025
See all 45 drugs on the patent cliff →