In the US, biosimilars can launch from 2036. Vyvgart is sold by argenx. argenx: the US composition-of-matter patent expires in 2036, before any extension, and 12-year biologic exclusivity runs to December 2033. Myasthenia gravis and CIDP. Sales are argenx's product net sales, including Vyvgart Hytrulo.
Vyvgart'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.
Who's lined up to copy Vyvgart
No US filing found No Vyvgart biosimilar is approved or known to be in US development. Rival FcRn blockers such as J&J's Imaavy compete instead.
Patent-expiry estimate. argenx: the US composition-of-matter patent expires in 2036, before any extension, and 12-year biologic exclusivity runs to December 2033. Myasthenia gravis and CIDP. Sales are argenx's product net sales, including Vyvgart Hytrulo.
Among past biologics facing biosimilars: Humira's US sales fell to 65% of their 2022 level in its first full year of biosimilars (2023) and 16% two years later; Stelara's US sales fell to 57% of their 2024 level in its first full year of biosimilars (2025). See how past cliffs played out →
Pharma Patent Cliff by readouts.io. "Vyvgart patent expiration: US loss of exclusivity 2036." Updated 8 October 2026. https://pharmapatentcliff.com/vyvgart
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