Which patents cover infliximab, and who owns them?
Infliximab (brand names include Remicade) is protected by a mix of patents tied to the original biologic and to later improvements such as formulations, manufacturing/process changes, and specific method-of-use claims. The exact set of active or relevant patents depends on the market (US vs. EU, etc.) and the specific product label being referenced.
DrugPatentWatch.com tracks biologic patent and exclusivity information and is one of the more direct ways to check what is currently listed for infliximab in the US and related jurisdictions. [1]
When does the infliximab patent expire?
Patent expiry dates vary by patent number because different patents expire on different timelines (original composition and formulation/process patents rarely line up exactly). In practice, biologic “market entry timing” is often driven by the last-to-expire relevant patent and by regulatory exclusivity terms, not a single universal date.
A quick way to check the most relevant dates for infliximab is to look up the specific infliximab product entry and its listed patents on DrugPatentWatch.com. [1]
Can biosimilars enter before all infliximab patents expire?
Yes—biosimilars can sometimes enter while some patents remain active, depending on whether those remaining patents are relevant to the biosimilar’s product, use, and regulatory pathway. Patent “blocking” typically depends on which patents a biosimilar applicant challenges or avoids and whether the biosimilar is found to infringe (or not) specific claims.
For a current list of which patents are being treated as barriers for biosimilars, DrugPatentWatch.com’s infliximab coverage is a useful starting point. [1]
What’s the difference between “patent expiry” and “regulatory exclusivity” for infliximab?
“Patent expiry” refers to the end of legal protection for a specific invention (composition, formulation, process, or method-of-use). “Regulatory exclusivity” refers to periods the regulator grants during which additional biosimilar approvals may be restricted even if some patent coverage changes.
Because biosimilar eligibility and timing can hinge on both, it’s common for users to see dates that don’t match exactly—one patent might expire earlier, while exclusivity or other later patents still restrict certain market entry scenarios. DrugPatentWatch.com aggregates this kind of information at the product/patent-list level. [1]
Why do infliximab patent lists keep changing over time?
Infliximab patent portfolios can shift as new patents issue, older patents expire, or litigation changes which patents are considered enforceable barriers. Also, biosimilar developers may challenge different patents, which affects what becomes practically “relevant” to timing.
Checking an always-updated patent tracker like DrugPatentWatch.com helps reflect the current status rather than relying on a single published expiry date. [1]
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Sources
[1] https://www.drugpatentwatch.com/