FDA Orange Book
Is there a generic for Viberzi?
Viberzi contains eluxadoline. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Viberzi (eluxadoline). The Orange Book shows its last listed patent expires March 14, 2033.
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Viberzi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 75MG | Marketed (Rx) | None | 0 | None |
NDA 206940, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Viberzi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9115091 | July 7, 2028 | Drug substance, Drug product | U-1738 | 206940 |
| 9364489 | July 7, 2028 | Method of use | U-1709 | 206940 |
| 9789125 | July 7, 2028 | Drug product | U-2152 | 206940 |
| 9789125 | July 7, 2028 | Drug product | U-1709 | 206940 |
| 8691860 | July 7, 2028 | Drug substance | U-1709 | 206940 |
| 7741356 | May 27, 2029 | Drug substance, Drug product | None | 206940 |
| 12097187 | March 14, 2033 | Method of use | U-3475 | 206940 |
| 11007179 | March 14, 2033 | Drug product | None | 206940 |
| 11311516 | March 14, 2033 | Drug product | None | 206940 |
| 9675587 | March 14, 2033 | Drug product | None | 206940 |
| 11229627 | March 14, 2033 | Drug product | None | 206940 |
| 11160792 | March 14, 2033 | Drug product | None | 206940 |
| 10188632 | March 14, 2033 | Drug product | None | 206940 |
| 11090291 | March 14, 2033 | Drug product | None | 206940 |
| 11484527 | March 14, 2033 | Method of use | U-3475 | 206940 |
Viberzi NDC codes
Questions
Is there a generic for Viberzi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Viberzi (eluxadoline). The Orange Book shows its last listed patent expires March 14, 2033.
What is the generic name for Viberzi?
The active ingredient in Viberzi is eluxadoline, per the FDA Orange Book.
When does the Viberzi patent expire?
The last patent listed for Viberzi in the Orange Book expires March 14, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.