eluxadoline · Abbvie · NDA 206940
Viberzi
Blocked by patent: US 10188632, US 11007179, US 11090291, US 11160792, US 11229627, US 11311516, US 11484527, US 12097187, US 9675587.
FDA has approved 1 generic application (ANDA) for Viberzi, though its earliest generic-entry date is 14 Mar 2033 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 · 14 unexpired
15 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10188632 | drug product · sets the listed date | 14 Mar 2033 |
| US 11007179 | drug product · sets the listed date | 14 Mar 2033 |
| US 11090291 | drug product · sets the listed date | 14 Mar 2033 |
| US 11160792 | drug product · sets the listed date | 14 Mar 2033 |
| US 11229627 | drug product · sets the listed date | 14 Mar 2033 |
| US 11311516 | drug product · sets the listed date | 14 Mar 2033 |
| US 11484527 | use U-3475 · sets the listed date | 14 Mar 2033 |
| US 12097187 | use U-3475 · sets the listed date | 14 Mar 2033 |
| US 9675587 | drug product · sets the listed date | 14 Mar 2033 |
| US 7741356 | drug substance, drug product | 27 May 2029 |
| US 8691860 | drug substance, use U-1709 | 7 Jul 2028 |
| US 9115091 | drug substance, drug product, use U-1738 | 7 Jul 2028 |
| US 9364489 | use U-1709 | 7 Jul 2028 |
| US 9789125 | drug product, use U-1709, U-2152 | 7 Jul 2028 |
| US 9789125 listing row | drug product, use U-1709 | 7 Jul 2028 |
| US 9789125 listing row | drug product, use U-2152 | 7 Jul 2028 |
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
- Generic approved · ANDA 213511, Aurobindo Pharma · 206940-001Approved 2 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206940 · 001 · RLD | tablet, oral | 75MG | 14 Mar 2033 |
| 206940 · 002 · RLD | tablet, oral | 100MG | 14 Mar 2033 |