FDA Orange Book
Generic for Keppra
Keppra 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 is levetiracetam. 38 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
Run it in Rivvi
Map Keppra and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Keppra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 500MG/5ML (100MG/ML) | Marketed (Rx) | AP | 12 | AP |
| solution, oral | 100MG/ML | Marketed (Rx) | AA | 13 | AA |
| tablet, oral | 1GM | Marketed (Rx) | AB | 17 | AB |
| tablet, oral | 250MG | Marketed (Rx) | AB | 17 | AB |
| tablet, oral | 500MG | Marketed (Rx) | AB | 17 | AB |
| tablet, oral | 750MG | Marketed (Rx) | AB | 17 | AB |
NDA 021872, 021505, 021035, 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 |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 076919 | AB (A-rated, therapeutically equivalent) | November 4, 2008 | 500MG, 750MG |
| ACTAVIS MID ATLANTIC LLC | 078976 | AA (A-rated, therapeutically equivalent) | January 15, 2009 | 100MG/ML |
| AUROBINDO PHARMA LTD | 079063 | AA (A-rated, therapeutically equivalent) | January 15, 2009 | 100MG/ML |
| AUROBINDO PHARMA LTD | 078993 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 1GM, 250MG, 500MG, 750MG |
| INGENUS PHARMACEUTICALS LLC | 079042 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 1GM, 250MG, 500MG, 750MG |
| LUPIN LTD | 090025 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 1GM |
| PHARMAZONE | 078904 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 1GM |
| TORRENT PHARMACEUTICALS LTD | 078858 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 1GM, 250MG, 500MG, 750MG |
| LUPIN LTD | 078154 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 250MG, 500MG, 750MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 078526 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 250MG, 500MG, 750MG |
| PHARMAZONE | 076920 | AB (A-rated, therapeutically equivalent) | January 15, 2009 | 250MG, 500MG, 750MG |
| BIONPHARMA INC | 079120 | AA (A-rated, therapeutically equivalent) | January 16, 2009 | 100MG/ML |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 078774 | AA (A-rated, therapeutically equivalent) | February 10, 2009 | 100MG/ML |
| PRINSTON PHARMACEUTICAL INC | 078106 | AB (A-rated, therapeutically equivalent) | February 10, 2009 | 1GM, 250MG, 500MG, 750MG |
| NOVAX PRO PHARMA LLC | 078869 | AB (A-rated, therapeutically equivalent) | March 13, 2009 | 1GM, 250MG, 500MG, 750MG |
| OXFORD PHARMACEUTICALS LLC | 077319 | AB (A-rated, therapeutically equivalent) | March 20, 2009 | 250MG, 500MG, 750MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 090263 | AA (A-rated, therapeutically equivalent) | April 3, 2009 | 100MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 078918 | AB (A-rated, therapeutically equivalent) | April 29, 2009 | 1GM, 250MG |
| AMNEAL PHARMACEUTICALS | 090992 | AA (A-rated, therapeutically equivalent) | October 27, 2009 | 100MG/ML |
| MYLAN PHARMACEUTICALS INC | 090261 | AB (A-rated, therapeutically equivalent) | December 8, 2009 | 1GM |
| RISING PHARMA HOLDINGS INC | 090767 | AB (A-rated, therapeutically equivalent) | July 28, 2010 | 1GM, 250MG, 500MG, 750MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 090484 | AB (A-rated, therapeutically equivalent) | August 5, 2010 | 1GM |
| AJENAT PHARMACEUTICALS LLC | 090461 | AA (A-rated, therapeutically equivalent) | September 30, 2010 | 100MG/ML |
| HETERO LABS LTD UNIT III | 090515 | AB (A-rated, therapeutically equivalent) | October 8, 2010 | 1GM, 250MG, 500MG, 750MG |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD | 091491 | AB (A-rated, therapeutically equivalent) | December 14, 2010 | 1GM, 250MG, 500MG, 750MG |
| CHARTWELL RX SCIENCES LLC | 201293 | AB (A-rated, therapeutically equivalent) | June 14, 2011 | 1GM, 250MG, 500MG, 750MG |
| XGEN PHARMACEUTICALS DJB INC | 091485 | AP (A-rated, therapeutically equivalent) | August 5, 2011 | 500MG/5ML (100MG/ML) |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 090981 | AP (A-rated, therapeutically equivalent) | October 13, 2011 | 500MG/5ML (100MG/ML) |
| HOSPIRA INC | 202869 | AP (A-rated, therapeutically equivalent) | April 6, 2012 | 500MG/5ML (100MG/ML) |
| QUAGEN PHARMACEUTICALS LLC | 090079 | AA (A-rated, therapeutically equivalent) | April 11, 2012 | 100MG/ML |
| HETERO LABS LTD UNIT III | 203052 | AA (A-rated, therapeutically equivalent) | February 28, 2013 | 100MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 203067 | AA (A-rated, therapeutically equivalent) | May 9, 2013 | 100MG/ML |
| SAGENT PHARMACEUTICALS INC | 091627 | AP (A-rated, therapeutically equivalent) | June 26, 2013 | 500MG/5ML (100MG/ML) |
| PHARMACEUTICAL ASSOCIATES INC | 201157 | AA (A-rated, therapeutically equivalent) | June 4, 2015 | 100MG/ML |
| FRESENIUS KABI USA LLC | 090876 | AP (A-rated, therapeutically equivalent) | August 13, 2015 | 500MG/5ML (100MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 204312 | AP (A-rated, therapeutically equivalent) | February 1, 2016 | 500MG/5ML (100MG/ML) |
| MYLAN LABORATORIES LTD | 203308 | AP (A-rated, therapeutically equivalent) | September 16, 2016 | 500MG/5ML (100MG/ML) |
| HAINAN POLY PHARMACEUTICAL CO LTD | 209781 | AP (A-rated, therapeutically equivalent) | March 20, 2018 | 500MG/5ML (100MG/ML) |
| MICRO LABS LTD | 211954 | AP (A-rated, therapeutically equivalent) | August 9, 2019 | 500MG/5ML (100MG/ML) |
| SCIEGEN PHARMACEUTICALS INC | 215069 | AB (A-rated, therapeutically equivalent) | June 11, 2021 | 1GM, 250MG, 500MG, 750MG |
| PRINSTON PHARMACEUTICAL INC | 209474 | AP (A-rated, therapeutically equivalent) | March 28, 2022 | 500MG/5ML (100MG/ML) |
| ALKEM LABORATORIES LTD | 216375 | AB (A-rated, therapeutically equivalent) | May 27, 2022 | 1GM, 250MG, 500MG, 750MG |
| MSN LABORATORIES PRIVATE LTD | 214757 | AA (A-rated, therapeutically equivalent) | July 15, 2022 | 100MG/ML |
| MSN LABORATORIES PRIVATE LTD | 214815 | AB (A-rated, therapeutically equivalent) | October 7, 2022 | 1GM, 250MG, 500MG, 750MG |
| MSN LABORATORIES PRIVATE LTD | 215980 | AP (A-rated, therapeutically equivalent) | November 15, 2022 | 500MG/5ML (100MG/ML) |
| ADAPTIS PHARMA PRIVATE LTD | 218080 | AA (A-rated, therapeutically equivalent) | November 21, 2025 | 100MG/ML |
| BAXTER HEALTHCARE CORP | 208458 | AP (A-rated, therapeutically equivalent) | August 6, 2026 | 500MG/5ML (100MG/ML) |
Keppra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8802142 | June 7, 2031 | Drug product | None | 021035 |
| 8802142*PED | December 7, 2031 | Method of use | None | 021035 |
Keppra NDC codes
Questions
Is there a generic for Keppra?
Yes. The generic name for Keppra is levetiracetam. 38 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
What is the generic name for Keppra?
The active ingredient in Keppra is levetiracetam, per the FDA Orange Book.
When does the Keppra patent expire?
The last patent listed for Keppra in the Orange Book expires December 7, 2031. 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.
More on Keppra and Levetiracetam
- What is Keppra used for?FDA label uses
- Is Keppra a controlled substance?Federal schedule
- What is Levetiracetam used for?FDA label uses
- Is Levetiracetam a controlled substance?Federal schedule
- Generic for Keppra XRFDA Orange Book
- Generic for SpritamFDA Orange Book
- NDC 50474-001Keppra NDC record
- NDC 50474-002Keppra NDC record
- NDC 50474-594Keppra NDC record