When did Dotarem (gadoteric acid) patents expire worldwide?
Dotarem’s active ingredient is gadoteric acid, and the “patent expired worldwide” date is not a single uniform day. Patent and related exclusivity timelines are set country-by-country (and sometimes by product formulation, method-of-use, or local regulatory exclusivity), so different countries can reach generic entry at different times even when the drug is the same worldwide.
What should you check to find the exact expiry date in each country?
To determine when generic competition can start in a specific market, you typically need to review:
- The primary compound patent for gadoteric acid (if still active in that territory).
- Any secondary patents (salt/formulation, manufacturing process, or specific claims tied to the product).
- Local regulatory exclusivity rules (these can delay generic launch even after a patent date passes).
- Whether the patent was litigated, invalidated, or had term adjustments in that country.
Without the specific country list (or the specific Dotarem patent numbers/assignee), a precise “worldwide expiry” date can’t be stated accurately.
Is there one global generic-entry date you can use?
No. A global “expiry date” is usually a misconception for branded pharmaceuticals. The earliest expiry among major markets may not match the latest expiry, and some territories can have additional protections that extend timelines.
If you tell me the country (or patent numbers), can you map the expiry?
Yes. If you share either:
- the countries you care about (for example: US, EU5, UK, Canada, Japan, China, India, etc.), or
- the relevant Dotarem patent numbers/holders you’re looking at,
then I can help you determine the expected earliest expiry/launch windows by territory based on the provided materials.
What I need from you to answer precisely
Reply with:
1) Which markets you mean by “worldwide” (all countries is too broad), and
2) Whether you want “patent expiry” only, or also “earliest generic launch” considering regulatory exclusivity.