Short answer: in major markets the core patents on Remicade (infliximab) have largely expired, which has enabled biosimilar infliximab products. The exact expiry dates depend on country and on which patent family (composition, manufacturing process, formulation, or use) you’re looking at. If you need precise dates for a specific country, I can help look them up.
What to know at a high level
- Composition-of-matter patents (the molecule infliximab) typically expired many years ago in the US, EU, and other large markets.
- Secondary patents (manufacturing processes, formulations, methods of use) may have expired in some jurisdictions earlier or later, and occasionally there are still limited protections in certain places.
- Regulatory exclusivity mechanisms (such as data exclusivity for biologics, SPCs in the EU, or other market protections) can affect when biosimilars can enter a market, even if patents have expired. In the US, the 12-year data exclusivity for the original biologic generally expired long ago, so it’s not a broad barrier for infliximab today, though country-specific rules apply.
- Today, multiple infliximab biosimilars are marketed in the US, EU, and other regions (e.g., Inflectra, Renflexis, Ixifi in the US; several biosimilars in Europe), which reflects broad patent expiry in many jurisdictions.
If you want precise expiry dates for a specific country (US, EU member states, UK, Japan, etc.), tell me:
- which country or region you care about,
- whether you want the status for the original molecule patent, manufacturing/process patents, or use/formulation patents, and
- if you want dates only or also patent numbers.
I can then pull the current official sources (FDA Purple Book, USPTO/EPO/JP patent databases, Espacenet, etc.) and give you a country-by-country rundown with patent numbers and expiry dates.