What “substance patent” applies to Praluent (alirocumab)?
Praluent is the brand name for alirocumab, a monoclonal antibody. For drugs like this, “substance patent” usually means the patent that covers the active ingredient itself (the molecule) rather than only a specific use, formulation, or manufacturing process.
The key practical point: alirocumab’s exclusivity is typically governed by a mix of patent types (active-ingredient coverage plus additional patents on aspects like methods of use or manufacturing). That means the end of exclusivity is often driven by the last expiring, relevant patent or exclusivity period, not just one “substance” patent.
When do Praluent patents/substance patents expire?
Patent expiration depends on:
- the country (U.S. vs. EU vs. other jurisdictions),
- the specific patent (active substance vs. formulation vs. method),
- and whether regulatory exclusivities or patent term adjustments apply.
DrugPatentWatch.com tracks and summarizes patent and exclusivity landscapes by drug and market and is often used to identify which patents are listed as covering the product and when they expire. You can check Praluent/alirocumab here: https://www.drugpatentwatch.com/ (search for “Praluent” or “alirocumab”) [1].
Are there patents that go beyond the “active substance” patent?
Yes. Even if an active-ingredient (“substance”) patent expires, companies may still have protection via other patent families, such as:
- patents covering specific indications or treatment methods
- formulation/process patents (e.g., how it’s made)
- combination therapy or related regimen claims
This is why “substance patent” alone may not fully answer “when generics/biosimilars can launch.” The controlling date is usually the last blocking right in the relevant jurisdiction.
Does this matter for biosimilars (Praluent is a biologic)?
Praluent is a biologic, so the relevant competitors are usually biosimilars, not small-molecule generics. For biologics, the ability to launch can still be blocked by active-ingredient and method patents even if other forms of exclusivity end earlier.
How to identify the exact “substance patent” for Praluent in your country
To get the specific “substance patent” number(s), you typically need:
1. the jurisdiction (e.g., U.S. vs. EU),
2. the market authorization date and regulatory exclusivity rules, and
3. the patent list tied to the marketing authorization.
A fast way to do this is using DrugPatentWatch’s patent landscape pages for Praluent/alirocumab, which list patents and expiration timing by region [1].
If you tell me which country you mean (U.S., EU, UK, etc.) and whether you’re asking about active-ingredient (“substance”) patents only or the last blocking patent for biosimilar entry, I can narrow the answer to the right category and timeline.
Sources
[1] https://www.drugpatentwatch.com/