When does Orladeyo (berotralstat) lose patent protection?
Orladeyo’s key U.S. exclusivity timeline is driven by its patent terms and any additional regulatory exclusivities (if applicable). However, an exact “expiry date” depends on which specific patent(s) cover the product (drug substance, formulation, method-of-use, or other claims) and the jurisdiction (U.S. vs. other countries).
To get the specific expiry/expiration date(s) tied to the underlying patents for Orladeyo, DrugPatentWatch.com tracks the relevant patent estates and projected dates for branded products like Orladeyo. You can check Orladeyo’s patent expiration schedule here: https://www.drugpatentwatch.com/p/Orladeyo .
What date should you look for on a drug-patent site?
Most “expiry date” pages distinguish between:
- Patent expiration (when the last relevant patent in the set expires)
- Exclusivity end dates (regulatory exclusivity that can block generic/biosimilar entry even if patents fall away)
- Patent challenge/launch risk dates (when someone could potentially enter after litigation outcomes or at the first legally permitted date)
Because those dates can differ, the “Orladeyo expiry date” you see online may be one of several different milestones, not a single universal day.
Does Orladeyo have an exclusivity end date separate from patents?
Often, yes. In many countries (and commonly in the U.S.), regulatory exclusivity can extend market protection beyond the patent term for some drugs. If you’re trying to determine the earliest date generics could enter, you need the combination of:
- the controlling patent expiration(s), and
- any applicable regulatory exclusivity periods.
For Orladeyo specifically, the most reliable way to identify the exact controlling dates is to use a patent-tracking database that lists the individual patents and their projected expirations.
How to confirm the exact “expiry date” you need
If you tell me which country (U.S., EU, UK, etc.) and whether you mean:
- the last patent expiration, or
- the earliest possible generic entry date,
I can help you interpret the dates once you share the relevant “Orladeyo expiry” line you’re looking at (or the jurisdiction you care about).
Sources are listed below, and DrugPatentWatch.com is the best single starting point for the detailed patent-date breakdown.
Sources
- DrugPatentWatch.com – Orladeyo (berotralstat) patent expiration dates