FDA Orange Book
Generic for Keppra XR
Keppra XR contains levetiracetam. 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
Yes. The generic name for Keppra XR is levetiracetam. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Keppra XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 500MG | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | 750MG | Marketed (Rx) | AB | 10 | AB |
NDA 022285, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levetiracetam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 091093 | AB (A-rated, therapeutically equivalent) | September 12, 2011 | 500MG, 750MG |
| APOTEX INC | 091261 | AB (A-rated, therapeutically equivalent) | September 12, 2011 | 500MG, 750MG |
| LUPIN LIMITED | 091399 | AB (A-rated, therapeutically equivalent) | September 12, 2011 | 500MG, 750MG |
| TORRENT PHARMACEUTICALS LTD | 091338 | AB (A-rated, therapeutically equivalent) | May 29, 2012 | 500MG, 750MG |
| PRINSTON PHARMACEUTICAL INC | 203468 | AB (A-rated, therapeutically equivalent) | May 21, 2015 | 500MG, 750MG |
| ANDA REPOSITORY LLC | 204511 | AB (A-rated, therapeutically equivalent) | February 23, 2016 | 500MG, 750MG |
| AIPING PHARMACEUTICAL INC | 204754 | AB (A-rated, therapeutically equivalent) | August 26, 2016 | 500MG, 750MG |
| HISUN PHARMACEUTICAL (HANGZHOU) CO LTD | 207175 | AB (A-rated, therapeutically equivalent) | September 28, 2017 | 500MG, 750MG |
| SCIEGEN PHARMACEUTICALS INC | 205130 | AB (A-rated, therapeutically equivalent) | November 27, 2020 | 500MG, 750MG |
| YABAO PHARMACEUTICAL CO LTD BEIJING | 212688 | AB (A-rated, therapeutically equivalent) | May 5, 2023 | 500MG, 750MG |
Keppra XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7858122 | September 17, 2028 | Drug product | None | 022285 |
Keppra XR NDC codes
Questions
Is there a generic for Keppra XR?
Yes. The generic name for Keppra XR is levetiracetam. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Keppra XR?
The active ingredient in Keppra XR is levetiracetam, per the FDA Orange Book.
When does the Keppra XR patent expire?
The last patent listed for Keppra XR in the Orange Book expires September 17, 2028. 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.