Drug facts
MoleculeIbrutinib (Imbruvica)
Generics already compete: 1 maker on the market. 1 A-rated product from 1 maker substitute at the counter.
Imbruvica was first approved by the FDA on 11/13/2013 under NDA 205552; the application holder is Pharmacyclics LLC.
Holder Pharmacyclics LLCApplication NDA 205552Approved 11/13/2013
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.
3,097days until the latest NDA 205552 patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved11/13/2013
Exclusivity ends02/24/2030
Last patent04/24/2035
201420182022202620302034
- Latest patent
- 04/24/2035Imbruvica Orange Book
- Exclusivity
- 02/24/2030Imbruvica Orange Book
- Later patents, other products
- Imbruvica (NDA 217003) 06/14/2039; Imbruvica (NDA 210563) 09/03/2036 Orange Book
02Competition
- Generics
- 1 generic maker Orange Book
- Staged generics
- 6 passed FDA review, awaiting market entry FDA
- First generic approved
- 03/31/2021 Orange Book
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 Ibrutinib profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Pharmacyclics LLC Orange Book
- Application
- NDA 205552 Orange Book
- First approved
- 11/13/2013 Orange Book
- Dosage forms
- capsule; suspension; tablet
- 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.