rifaximin · Salix Pharms · NDA 021361
Xifaxan
Other strengths are listed to 2 Oct 2029.
Blocked by patent: US 10314828, US 10335397, US 10709694, US 7928115, US 8829017, US 8946252, US 9421195, US 9629828. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 1 generic application (ANDA) for Xifaxan, though its earliest generic-entry date is 24 Jul 2029 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 15 unexpired
20 Orange Book listing rows for 15 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8642573 | use U-1481 | 2 Oct 2029 |
| US 8969398 | use U-1481 | 2 Oct 2029 |
| US 10314828 | use U-1481 · sets the listed date | 24 Jul 2029 |
| US 10335397 | use U-2579 · sets the listed date | 24 Jul 2029 |
| US 10709694 | use U-2579 · sets the listed date | 24 Jul 2029 |
| US 7928115 | use U-1121 · sets the listed date | 24 Jul 2029 |
| US 8829017 | use U-1562 · sets the listed date | 24 Jul 2029 |
| US 8946252 | use U-1481 · sets the listed date | 24 Jul 2029 |
| US 9421195 | use U-1481 · sets the listed date | 24 Jul 2029 |
| US 9629828 | use U-1994 · sets the listed date | 24 Jul 2029 |
| US 10456384 | use U-2643, U-2644 | 26 Feb 2029 |
| US 10456384 listing row | use U-2643 | 26 Feb 2029 |
| US 10456384 listing row | use U-2644 | 26 Feb 2029 |
| US 10765667 | use U-2643, U-2644 | 26 Feb 2029 |
| US 10765667 listing row | use U-2643 | 26 Feb 2029 |
| US 10765667 listing row | use U-2644 | 26 Feb 2029 |
| US 11564912 | use U-3511, U-3512 | 26 Feb 2029 |
| US 11564912 listing row | use U-3511 | 26 Feb 2029 |
| US 11564912 listing row | use U-3512 | 26 Feb 2029 |
| US 11779571 | use U-3706 | 26 Feb 2029 |
| US 8193196 | drug substance, drug product, use U-1707, U-1708 | 2 Sep 2027 |
| US 8193196 listing row | drug substance, drug product | 2 Sep 2027 |
| US 8193196 listing row | drug substance, drug product, use U-1707 | 2 Sep 2027 |
| US 8193196 listing row | drug substance, drug product, use U-1708 | 2 Sep 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- First generic approved · ANDA 208959, Actavis Labs Fl Inc · 021361-001Approved 19 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 208959, Actavis Labs Fl Inc · 021361-001Approved 19 Mar 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 220451, Alkem Laboratories Limited · 021361-001Tentative approval 20 Mar 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 219687, Mylan Pharmaceuticals Inc · 021361-001Tentative approval 7 Jan 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 219570, Cipla Ltd · 021361-001Tentative approval 16 Mar 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021361 · 001 · RLD | tablet, oral | 200MG | 24 Jul 2029 |
| 021361 · 002 · RLD | tablet, oral | 550MG | 2 Oct 2029 |
Expired or delisted (11)
- US 8309569 · use U-1707 · 18 Jul 2029 · delisted
- US 8309569 · use U-1708 · 18 Jul 2029 · delisted
- US 10703763 · use U-2847 · 27 Feb 2026
- US 10703763 · use U-2848 · 27 Feb 2026
- US 10703763 · use U-1708 · 27 Feb 2026
- US 8518949 · product · 27 Feb 2026
- US 8741904 · substance, product, use U-1707 · 27 Feb 2026
- US 8741904 · substance, product, use U-1708 · 27 Feb 2026
- US 8741904 · substance, product, use U-2848 · 27 Feb 2026
- US 8741904 · substance, product, use U-2847 · 27 Feb 2026
- US 9271968 · product · 27 Feb 2026