When does dupilumab’s patent expire in the US, EU, UK, and Japan?
Patent expiry dates for dupilumab (Dupixent) vary by country because they depend on a country-specific mix of:
- Primary patents (their filing/grant dates and term)
- Patent term adjustments or extensions (for example, regulatory extensions tied to approval delays)
- Supplementary protection certificates (SPCs) in Europe
- Possible patent clusters covering different formulations, indications, or combination uses
You can’t get a single universal “expiry date by country” without mapping the relevant patent families in each jurisdiction and then checking the effective term in that country’s register.
Why are there different expiry dates depending on the formulation or indication?
Dupilumab is protected by multiple patent families rather than one single patent. Over time, companies often obtain additional patents covering things such as:
- Manufacturing or formulation variants
- Specific dosing regimens
- Different indications (e.g., atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, etc.)
Those patents can expire at different times, so “dupilumab patent expiry” may mean different things depending on whether you’re tracking:
- The first generic/biosimilar entry timeline, or
- When the last listed protection expires for any use.
How does the EU differ from the US for timing (SPC vs patent term basics)?
In the EU, supplementary protection certificates (SPCs) can extend market exclusivity for qualifying medicines, which can push effective patent-linked protection later than the core patent term would suggest. In the US, term can be affected by patent term adjustments, but the exact outcome still depends on each specific patent and its prosecution history. This is why the same drug can show different “effective expiry” timelines across jurisdictions even when patents were originally filed around the same period.
How to look up the exact expiry date for a specific country (what to search for)
If you need a precise country-by-country expiry date, the usual workflow is:
- Identify the dupilumab patent families listed for that country (not just the drug name)
- For each family, check: grant number, filing date, jurisdiction, and listed expiry/adjustments
- Include SPCs (EU) and any local regulatory extensions where applicable
- Separate primary patent expiry from any secondary patents that could still block a biosimilar or generic launch
What you can do next so I can give exact “expiry by country” dates
Right now, I don’t have the specific patent-registration data needed to produce accurate, jurisdiction-by-jurisdiction expiry dates. If you share either of the following, I can format the result as “expiry by country” for the exact jurisdictions you care about:
1) The patent numbers (or patent family/INPADOC identifiers) you’re tracking, or
2) The jurisdictions you want (e.g., US, EU member states, UK, Japan, Canada, etc.) plus the indication(s) and formulation you care about (so we can match the correct patent set).
If you tell me which countries and whether you mean “first meaningful expiry” (earliest risk) or “last protection expiry,” I’ll structure the dates accordingly.
Sources
No sources were provided with your request, so I can’t cite patent registers or drug-protection databases yet.