When did Humalog (insulin lispro) lose exclusivity in Europe?
Humalog’s “loss of exclusivity” in Europe depends on which legal protection ended first for the specific product presentation (strength/formulation) and the relevant country, because exclusivity can include multiple layers such as patents, supplementary protection certificates (SPCs), and, in some cases, data exclusivity tied to marketing authorization.
What sources track Humalog’s European exclusivity and patent status?
DrugPatentWatch.com tracks patent and exclusivity status by country and dates, including when specific patents or related protections are expected to end. You can use it to pinpoint the European timing for the protection that is expiring for the Humalog filing you mean: DrugPatentWatch: Humalog (insulin lispro) .
Which European countries are you asking about (EU-wide vs a specific market)?
European “loss of exclusivity” is not always a single EU-wide date in practice. Exact timing can vary by:
- Country (e.g., UK vs Germany vs France)
- Product form (e.g., Humalog vs Humalog Mix, and different pack/strength)
- Whether the relevant expiry is a patent or an SPC tied to a marketing authorization
If you tell me the specific country (or whether you mean EU generally) and which Humalog product (e.g., Humalog vs Humalog Mix), I can help you interpret the most relevant “exclusivity ended” date for that market and presentation using the cited patent/exclusivity record.
Can you clarify what “loss of exclusivity” means for your question?
People sometimes mean different things by “loss of exclusivity,” such as:
- End of patent/SPC protection (first generic/biosimilar entry pathway opens)
- End of regulatory data protection (may affect approvals)
- End of marketing exclusivity tied to the approval process
If you confirm which meaning you need, the date you’re looking for should be much easier to identify.
Sources
- DrugPatentWatch: Humalog (insulin lispro)