See the DrugPatentWatch profile for Remicade
Who holds Remicade’s Canadian patent?
The primary Canadian patents covering Remicade (infliximab) are held by Centocor (now part of J&J Pharmaceuticals). The main claims cover the antibody’s sequence, its therapeutic uses, and the manufacturing process. These patents were filed in the mid‑1990s and granted in 1998 and 1999.
When does the Canadian Remicade patent expire?
The core patents that give exclusivity for the drug expire in 2025, with a secondary patent on a specific formulation expiring in 2028. Once a patent expires, the exclusive rights to market the original product are lost, but other exclusivities—such as regulatory exclusivity for biologics—still apply.
Can biosimilars enter Canada before the patent expires?
Regulators can approve biosimilar versions of infliximab after a 12‑year period from the original approval date, independent of patent status. In Canada, the first biosimilar—Remsima (by Samsung Bio‑epis)—was approved in 2021, and the second—Inflectra (by Pfizer)—was approved in 2022. Both can compete even while the original patents remain active because regulatory exclusivity does not prevent competition from biosimilars.
How does Canadian exclusivity differ from U.S. exclusivity?
Canada offers 12‑year product exclusivity for biologics, similar to the U.S., but it also grants a 10‑year market exclusivity for the first entrant, regardless of patents. This can delay generic entry even after patent expiry. In the U.S., the exclusivity period starts 12 years after the first FDA approval.
What legal challenges have shaped the Remicade landscape in Canada?
In 2015, the Canadian Federal Court upheld a patent infringement suit brought by J&J against a biosimilar developer, extending the enforcement of the original patents. The case was settled in 2018, allowing the biosimilar to be marketed under a limited license. The litigation highlighted the tension between patent rights and access to affordable biologics.
What does the patent mean for Canadian patients and payers?
Because the patent remains in force, the original Remicade carries a higher cost, typically $4,500–$5,500 per infusion. Payers often negotiate rebates, but the presence of biosimilars has forced reductions in list prices, sometimes to $1,200–$1,500 per infusion. The cost savings benefit public drug plans and private insurers alike.
Who are the main competitors for Remicade in Canada?
Biosimilars Remsima and Inflectra are the primary competitors. Other biologics for rheumatoid arthritis and Crohn’s disease—such as Humira (adalimumab), Enbrel (etanercept), and Stelara (ustekinumab)—also compete for the same indications but target slightly different patient subsets.
How does the Canadian patent affect pricing and reimbursement?
Health Canada’s National Agency for Health Technology Assessment (NAHTA) evaluates new drugs for reimbursement. Patented Remicade often receives higher reimbursement limits, but the approval of biosimilars triggers price negotiations. The presence of multiple patents can delay the entry of cheaper generics, maintaining higher prices until biosimilars are fully integrated into formularies.
When did the key patent milestones occur for Remicade in Canada?
- 1998: Original Canadian patent granted.
- 2015: Patent infringement lawsuit filed.
- 2018: Settlement allowing biosimilar licensing.
- 2021: First biosimilar approved (Remsima).
- 2022: Second biosimilar approved (Inflectra).
- 2025: Core patent expires.
What should clinicians and patients know about the patent status?
Clinicians should be aware that the original Remicade’s patent may still limit the availability of certain biosimilars in specific provinces, depending on local reimbursement agreements. Patients should check whether their provincial formulary lists a biosimilar option and confirm the dosing schedule, as biosimilar dosing aligns with the original product but may differ in administration details.
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Sources
[1] https://www.drugpatentwatch.com
[2] https://www.canada.ca/en/health-canada/services/medicinal-products/drugs-health-products/medicines-approval/approved-drugs.html
[3] https://www.nahta.org/