Orange Book product · Brand (NDA)
XIFAXAN
RIFAXIMIN
At a glance
May 25, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 2004
22 yr 5 mo ago
Patent 10703763 expires
Listed method-of-use patent (U-2848) expiration.
Feb 27, 2026
4 mo ago
Patent 8518949 expires
Listed drug product patent expiration.
Feb 27, 2026
4 mo ago
Patent 8741904 expires
Listed drug substance patent expiration.
Feb 27, 2026
4 mo ago
Patent 9271968 expires
Listed drug product patent expiration.
Feb 27, 2026
4 mo ago
Today
Patent 8193196 expires
Listed drug substance patent expiration.
Sep 02, 2027
in 1 yr 3 mo
Patent 7928115 expires
Listed method-of-use patent (U-1121) expiration.
Jul 24, 2029
in 3 yr 2 mo
Pharmaceutical detail
Active ingredient
RIFAXIMIN
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021361
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10703763 | Feb 27, 2026 | 4 mo ago | U-2848 |
| 8518949 | Feb 27, 2026 | 4 mo ago | Product |
| 8741904 | Feb 27, 2026 | 4 mo ago | SubstanceProductU-2848 |
| 9271968 | Feb 27, 2026 | 4 mo ago | Product |
| 8193196 | Sep 02, 2027 | in 1 yr 3 mo | SubstanceProduct |
| 7928115 | Jul 24, 2029 | in 3 yr 2 mo | U-1121 |
