FDA Orange Book
Is there a generic for Horizant?
Horizant contains gabapentin enacarbil. 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 Horizant (gabapentin enacarbil). The Orange Book shows its last listed patent expires June 10, 2029.
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Horizant products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 300MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 600MG | Marketed (Rx) | None | 0 | None |
NDA 022399, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Horizant patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8114909 | April 11, 2026 | Method of use | U-1231 | 022399 |
| 8026279 | November 10, 2026 | Drug substance, Drug product | None | 022399 |
| 8795725 | June 10, 2029 | Drug product | U-1231 | 022399 |
| 8795725 | June 10, 2029 | Drug product | U-1247 | 022399 |
Horizant NDC codes
Questions
Is there a generic for Horizant?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Horizant (gabapentin enacarbil). The Orange Book shows its last listed patent expires June 10, 2029.
What is the generic name for Horizant?
The active ingredient in Horizant is gabapentin enacarbil, per the FDA Orange Book.
When does the Horizant patent expire?
The last patent listed for Horizant in the Orange Book expires June 10, 2029. 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.