FDA Orange Book · active-ingredient family
Rifaximin
Rifaximin is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XIFAXAN · NDA 021361
1
Brand (NDA)
1
Generics (ANDA)
20
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XIFAXANRLD×2 | SALIX PHARMS | NDA 021361 | — | May 25, 2004 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIFAXIMIN | ACTAVIS LABS FL INC | ANDA 208959 | AB | Mar 19, 2026 |
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10703763 | Feb 27, 2026 | 4 mo ago | U-2848 |
| 8741904 | Feb 27, 2026 | 4 mo ago | SubstanceProductU-2848 |
| 8518949 | Feb 27, 2026 | 4 mo ago | Product |
| 9271968 | Feb 27, 2026 | 4 mo ago | Product |
| 8193196 | Sep 02, 2027 | in 1 yr 3 mo | SubstanceProduct |
| 10456384 | Feb 26, 2029 | in 2 yr 9 mo | U-2643 |
| 10765667 | Feb 26, 2029 | in 2 yr 9 mo | U-2644 |
| 11779571 | Feb 26, 2029 | in 2 yr 9 mo | U-3706 |
| 11564912 | Feb 26, 2029 | in 2 yr 9 mo | U-3511 |
| 8309569 | Jul 18, 2029 | in 3 yr 2 mo | U-1708Delisted |
| 7928115 | Jul 24, 2029 | in 3 yr 2 mo | U-1121 |
| 8829017 | Jul 24, 2029 | in 3 yr 2 mo | U-1562 |
| 9421195 | Jul 24, 2029 | in 3 yr 2 mo | U-1481 |
| 8946252 | Jul 24, 2029 | in 3 yr 2 mo | U-1481 |
| 10335397 | Jul 24, 2029 | in 3 yr 2 mo | U-2579 |
| 9629828 | Jul 24, 2029 | in 3 yr 2 mo | U-1994 |
| 10314828 | Jul 24, 2029 | in 3 yr 2 mo | U-1481 |
| 10709694 | Jul 24, 2029 | in 3 yr 2 mo | U-2579 |
| 8642573 | Oct 02, 2029 | in 3 yr 4 mo | U-1481 |
| 8969398 | Oct 02, 2029 | in 3 yr 4 mo | U-1481 |
Rifaximin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
