Drug facts
BrandCalquence (Acalabrutinib)
No generic version of Calquence is approved; the latest Calquence patent or exclusivity in the Orange Book runs to 07/01/2036. 2 staged generic applications passed FDA review and wait on patents or exclusivity.
Calquence was first approved by the FDA on 10/31/2017 under NDA 210259; the application holder is Astrazeneca UK Ltd.
Holder Astrazeneca UK LtdApplication NDA 210259Approved 10/31/2017
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
3,531days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved10/31/2017
Exclusivity ends02/19/2029
Last patent07/01/2036
2018202120242027203020332036
- Latest patent
- 07/01/2036Calquence Orange Book
- Exclusivity
- 02/19/2029Calquence Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 2 passed FDA review, awaiting market entry FDA
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Calquence profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Astrazeneca UK Ltd Orange Book
- Application
- NDA 210259 Orange Book
- First approved
- 10/31/2017 Orange Book
- Dosage forms
- capsule
- Routes
- oral
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.