Drug facts
BrandJakafi (Ruxolitinib)
No generic ruxolitinib is approved; the latest Jakafi patent or exclusivity in the Orange Book runs to 03/22/2029. 2 staged generic applications passed FDA review and wait on patents or exclusivity.
Jakafi was first approved by the FDA on 11/16/2011 under NDA 202192; the application holder is Incyte Corp.
Holder Incyte CorpApplication NDA 202192Approved 11/16/2011
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.
873days until Jakafi exclusivity ends
ExclusivityPatent onlyOpen to generics
Today
Approved11/16/2011
Last patent12/12/2028
Exclusivity ends03/22/2029
2012201520182021202420272030
- Latest patent
- 12/12/2028Jakafi Orange Book
- Exclusivity
- 03/22/2029Jakafi Orange Book
- Later patents, other products
- Opzelura 05/05/2041; Jakafi XR 07/17/2034 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 Jakafi profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Incyte Corp Orange Book
- Application
- NDA 202192 Orange Book
- First approved
- 11/16/2011 Orange Book
- Dosage forms
- tablet
- Routes
- oral
- Other brand names
- Jakafi XROpzelura
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.