FDA Orange Book · active-ingredient family
Eluxadoline
Eluxadoline is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VIBERZI · NDA 206940
1
Brand (NDA)
2
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIBERZIRLD×2 | ABBVIE | NDA 206940 | AB | May 27, 2015 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELUXADOLINE×2 | AUROBINDO PHARMA | ANDA 213511 | AB | Jun 02, 2026 | |
| ELUXADOLINE×2 | ZYDUS PHARMS | ANDA 213522 | — | Mar 14, 2025 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9115091 | Jul 07, 2028 | in 2 yr 1 mo | SubstanceProductU-1738 |
| 9364489 | Jul 07, 2028 | in 2 yr 1 mo | U-1709 |
| 9789125 | Jul 07, 2028 | in 2 yr 1 mo | ProductU-2152 |
| 8691860 | Jul 07, 2028 | in 2 yr 1 mo | SubstanceU-1709 |
| 7741356 | May 27, 2029 | in 3 yr | SubstanceProduct |
| 12097187 | Mar 14, 2033 | in 6 yr 10 mo | U-3475 |
| 11007179 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11311516 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 9675587 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11229627 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11160792 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 10188632 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11090291 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11484527 | Mar 14, 2033 | in 6 yr 10 mo | U-3475 |
Eluxadoline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
