Ocrelizumab patent expiry?

Ocrelizumab (brand name Ocrevus) is a humanized anti‑CD20 monoclonal antibody that was first approved in 2017 for relapsing‑form MS and, in 2022, for primary progressive MS.
Because it is a biologic, the protection it enjoys is a mix of composition‑of‑matter patents, method‑of‑use patents, and patents covering manufacturing, formulations and delivery systems. The expiration of each of those can differ.

What does this mean for exclusivity?

• United States – The earliest “composition‑of‑matter” patent that is still enforceable is US 7,046,461, which expired in 2023. However, the remaining method‑of‑use and Fc‑engineering patents extend the protection until 2029–2030. Roche also has a biosimilar exclusivity period that can last up to 5 years after the first biosimilar is approved, so additional protection beyond the patent term is possible.

• European Union – The key EU patents expire in 2028–2030. In the EU, the “first‑in‑class” (first‑to‑file) and “first‑to‑market” provisions apply, so the same 20‑year term applies but the filing dates are slightly different from the US. Roche’s EU exclusivity will last until the later of the last patent expiry or the expiry of the biologics exclusivity period (up to 5 years after the first biosimilar approval).

When can generics/biosimilars enter the market?

• In the U.S., a biosimilar could file an Abbreviated BLA (a “biosimilar” filing) once the last relevant patent expires (i.e., after 2029) and the Biologics Price Competition and Innovation Act (BPCIA) exclusivity period ends. Because the method‑of‑use and Fc‑engineering patents are still active, a biosimilar would need to either challenge those patents or wait until they expire.

• In the EU, the first biosimilar could submit a Marketing Authorization once the last EU patent expires (2028–2030) and the EU’s biosimilar exclusivity (up to 5 years after first approval) is finished.

Bottom line

While the first ocrelizumab composition patent expired in 2023, the drug still enjoys a patchwork of remaining patents that are due to expire between 2027 and 2030 (depending on the jurisdiction). Consequently, Roche will retain exclusive commercial rights for the next several years, and biosimilar competition will not be able to enter the market until those later expiry dates (and any regulatory exclusivity periods) have lapsed.

If you’re a clinician, pharmacist, or patient – this means that currently (2026) there are no approved biosimilar or generic alternatives to Ocrevus; any future biosimilar would have to wait until the last of the relevant patents expires, typically late 2029 or early 2030 in the U.S. and 2028–2030 in the EU.