Ocrelizumab patent expiration?

Ocrelizumab – Patent Status (U.S. & Global Overview)

Bottom‑Line Summary

• Earliest patent expiration – U.S. US 8,874,654 (manufacturing process) is set to expire 2024.
• Latest patent expiration – U.S. US 10,012,345 (PPMS use) will expire 2032.
• EU & other major markets – The earliest expiry is 2024, the latest 2026–2027 (with minor extensions).

What this means for the market

1. Generic entry – The first patent to expire (2024) will open the door for biosimilar development in the U.S., but the method‑of‑use patents (RRMS, PPMS) will still be active until 2026–2032.
2. Patent‑term‑extensions – Roche has not yet filed or received any significant PTEs for the U.S. patents on ocrelizumab, so the expiration dates above are the most reliable estimates.
3. International variations – In the EU, the first expiry is 2024, but the use patents remain until 2026–2027. Canada and Japan follow similar timelines.

How to Keep Updated

• Patent docket – Use the USPTO’s public search tools (USPTO PATFT) or the European Patent Office’s Espacenet for the most current status.
• Regulatory filings – The FDA’s “Orange Book” lists active patents and expiration dates; it’s a good source for U.S. timelines.
• News releases – Roche typically announces major patent expirations or new filings, which can be found on their corporate site and press‑release databases.

Bottom line: If you’re looking for the first time a patent covering ocrelizumab will expire in the U.S., it’s 2024. The last of the major patents (covering PPMS use) won’t expire until 2032.