Orange Book product · Brand (NDA)
VIBERZI
ELUXADOLINE
At a glance
May 27, 2015
Approved
Brand (NDA)
Application
AB
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2015
11 yr 3 mo ago
Today
Patent 8691860 expires
Listed drug substance patent expiration.
Jul 07, 2028
in 2 yr 1 mo
Patent 9115091 expires
Listed drug substance patent expiration.
Jul 07, 2028
in 2 yr 1 mo
Patent 9364489 expires
Listed method-of-use patent (U-1709) expiration.
Jul 07, 2028
in 2 yr 1 mo
Patent 9789125 expires
Listed drug product patent expiration.
Jul 07, 2028
in 2 yr 1 mo
Patent 9789125 expires
Listed drug product patent expiration.
Jul 07, 2028
in 2 yr 1 mo
Patent 7741356 expires
Listed drug substance patent expiration.
May 27, 2029
in 3 yr
Patent 10188632 expires
Listed drug product patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Patent 11007179 expires
Listed drug product patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Patent 11090291 expires
Listed drug product patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Patent 11160792 expires
Listed drug product patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Patent 11229627 expires
Listed drug product patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Patent 11311516 expires
Listed drug product patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Patent 12097187 expires
Listed method-of-use patent (U-3475) expiration.
Mar 14, 2033
in 6 yr 10 mo
Patent 9675587 expires
Listed drug product patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
ELUXADOLINE
Strength
75MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 206940
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8691860 | Jul 07, 2028 | in 2 yr 1 mo | SubstanceU-1709 |
| 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 |
| 9789125 | Jul 07, 2028 | in 2 yr 1 mo | ProductU-1709 |
| 7741356 | May 27, 2029 | in 3 yr | SubstanceProduct |
| 10188632 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11007179 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11090291 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11160792 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11229627 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 11311516 | Mar 14, 2033 | in 6 yr 10 mo | Product |
| 12097187 | Mar 14, 2033 | in 6 yr 10 mo | U-3475 |
| 9675587 | Mar 14, 2033 | in 6 yr 10 mo | Product |
