Orange Book product · Brand (NDA)
HORIZANT
GABAPENTIN ENACARBIL
At a glance
Dec 13, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2011
14 yr 9 mo ago
Patent 8114909 expires
Listed method-of-use patent (U-1231) expiration.
Apr 11, 2026
2 mo ago
Today
Patent 8026279 expires
Listed drug substance patent expiration.
Nov 10, 2026
in 5 mo
Patent 8795725 expires
Listed drug product patent expiration.
Jun 10, 2029
in 3 yr
Patent 8795725 expires
Listed drug product patent expiration.
Jun 10, 2029
in 3 yr
Pharmaceutical detail
Active ingredient
GABAPENTIN ENACARBIL
Strength
300MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022399
Product number
002
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 (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8114909 | Apr 11, 2026 | 2 mo ago | U-1231 |
| 8026279 | Nov 10, 2026 | in 5 mo | SubstanceProduct |
| 8795725 | Jun 10, 2029 | in 3 yr | ProductU-1231 |
| 8795725 | Jun 10, 2029 | in 3 yr | ProductU-1247 |
