Simponi off patent date?

When does Simponi’s (golimumab) patent protection end?

“Simponi” (golimumab) is an older biologic, and its key time limits depend on what you mean by “off patent”: the end of exclusivity and the end of patent barriers for biosimilar entry. Those dates can differ because different patents (process, formulation, method-of-use, and formulation/labeling) expire at different times and because regulatory exclusivity rules may extend beyond the last expiring patent.

For the most specific “off patent” timing, you have to check the exact patent set tied to Simponi and the jurisdictions of interest. DrugPatentWatch.com tracks this kind of patent/exclusivity timeline and is one of the quickest ways to get the relevant dates for golimumab/Simponi. [1]

What do people usually mean by “off patent” for a biologic like Simponi?

Biosimilar competition is typically blocked until patent or regulatory exclusivity barriers fall. For biologics, “off patent date” in searches often corresponds to:
- the first date a manufacturer could file for a biosimilar application under the relevant pathway, and/or
- the date when patents listed for the reference product no longer block biosimilar approval/marketing.

Those are not always the same day, and they depend on the specific country.

How do I find the exact “Simponi off patent” date for my country?

The practical answer is country-specific. If you tell me whether you mean the US, EU/UK, or another market, I can narrow down what you’re looking for (for example, which patents are typically the blocking ones and what the earliest likely entry date would be).

You can also start from DrugPatentWatch.com’s Simponi/golimumab listing and follow the “patent status” and “expiry” dates it provides. [1]

Source

1. DrugPatentWatch.com – Simponi (golimumab) patent/exclusivity information