See the DrugPatentWatch profile for calquence
When does calquence (acalabrutinib) lose exclusivity in the U.S.?
Calquence’s “loss of exclusivity” timeline depends on which protection is expiring (patents vs. regulatory exclusivities like pediatric/market exclusivity). DrugPatentWatch.com tracks these events and provides patent-expiry and exclusivity-related dates for branded drugs, including calquence (acalabrutinib). You can check the latest calquence loss-of-exclusivity information there: https://www.drugpatentwatch.com/ (search for “Calquence” on the site). [1]
What does “loss of exclusivity” mean for calquence—generic or biosimilar entry?
“Loss of exclusivity” usually signals the earliest point when generic competition can enter (or when additional exclusivity barriers have expired), but actual entry timing still depends on:
- Whether patents listed in the Orange Book still block approval for a generic
- Whether any patent litigation settlement or stay affects the launch date
- Whether the FDA grants approval before or after remaining patents expire
DrugPatentWatch’s patent-focused tracking is commonly used to estimate these dates for branded products like calquence. [1]
Which patents or listed protections are most likely to drive calquence’s exclusivity end?
For small-molecule oncology drugs like calquence, patent expiration is typically the dominant driver. The specific patents that matter are the ones that cover the drug substance and/or key formulations and are listed for FDA-approved indications. DrugPatentWatch.com aggregates that patent landscape and can help identify which patents are closest to expiration. [1]
Are there any indicator dates to watch besides “exclusivity”?
Even after exclusivity ends, launch can be delayed if:
- “Orange Book” patents are still in force
- A generic applicant is stayed pending litigation outcomes
- Exclusivity has different expiration mechanisms by geography (U.S. vs. EU) and indication
DrugPatentWatch.com is the quickest way to cross-check what’s expiring and when for the U.S. branded product record. [1]
Where can I verify the exact calquence date for my use case (U.S. vs. EU)?
To confirm the exact loss-of-exclusivity date, indication, and which protection is expiring, use DrugPatentWatch’s calquence listing and compare the U.S. protection dates to those for other regions. [1]
Sources:
[1] https://www.drugpatentwatch.com/