Reblozyl expected to lose US exclusivity
Company guidance. BMS estimates US exclusivity to 2031, based on regulatory exclusivity; a method-of-treatment patent with term restoration runs to 2033. Anemia in MDS and beta thalassemia.
When does Reblozyl go off patent?
In the US, biosimilars can launch from 2031. Reblozyl is sold by Bristol Myers Squibb. BMS estimates US exclusivity to 2031, based on regulatory exclusivity; a method-of-treatment patent with term restoration runs to 2033. Anemia in MDS and beta thalassemia.
Reblozyl's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
No US filing found No Reblozyl biosimilar is approved, and we found no US program in development as of October 2026.
Checked October 2026. Sources: BMS 10-K 2025
Company guidance. BMS estimates US exclusivity to 2031, based on regulatory exclusivity; a method-of-treatment patent with term restoration runs to 2033. Anemia in MDS and beta thalassemia.
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 →
Reblozyl is 4.8% of Bristol Myers Squibb's 2025 revenue ($2.3B of $48.2B). With Pomalyst, Eliquis and Opdivo, the drugs tracked here add up to 61% of Bristol Myers Squibb's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Reblozyl is highlighted.