Drug facts
BrandXifaxan (Rifaximin)
1 generic maker holds FDA approval for rifaximin, but no generic is priced in NADAC yet; the latest Xifaxan patent or exclusivity in the Orange Book runs to 10/02/2029. 7 staged generic applications passed FDA review and wait on patents or exclusivity.
Xifaxan was first approved by the FDA on 05/25/2004 under NDA 021361; the application holder is Salix Pharmaceuticals Inc.
Holder Salix Pharmaceuticals IncApplication NDA 021361Approved 05/25/2004
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.
1,067days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved05/25/2004
Last patent10/02/2029
2005200920132017202120252029
- Latest patent
- 10/02/2029Xifaxan Orange Book
02Competition
- Generics
- 1 generic maker approved, none priced in NADAC yet Orange Book
- Staged generics
- 7 passed FDA review, awaiting market entry FDA
- First generic approved
- 03/19/2026 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 Xifaxan profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Salix Pharmaceuticals Inc Orange Book
- Application
- NDA 021361 Orange Book
- First approved
- 05/25/2004 Orange Book
- Dosage forms
- 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.