Generic competition · all medicines · read 12 November 2026
Is there a generic of Levetiracetam, and who makes it?
Levetiracetam appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 48 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 3 and 8.9 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Levetiracetam appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 48 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 3 and 8.9 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Keppra. 18 generic makers with 68 generic products listed as marketed; the first generic approval is dated 4 November 2008.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Pharmaceuticals Inc | 4 November 2008 | 3 |
| Aurobindo Pharma Ltd | 15 January 2009 | 4 |
| Ingenus Pharmaceuticals Llc | 15 January 2009 | 4 |
| Lupin Ltd | 15 January 2009 | 4 |
| Orbion Pharmaceuticals Private Ltd | 15 January 2009 | 4 |
| Pharmazone | 15 January 2009 | 4 |
| Torrent Pharmaceuticals Ltd | 15 January 2009 | 4 |
| Prinston Pharmaceutical Inc | 10 February 2009 | 4 |
| Novax Pro Pharma Llc | 13 March 2009 | 4 |
| Oxford Pharmaceuticals Llc | 20 March 2009 | 3 |
| Zydus Pharmaceuticals Usa Inc | 29 April 2009 | 2 |
| Rising Pharma Holdings Inc | 28 July 2010 | 4 |
6 more makers are listed in the data.
Patents and exclusivities still listed
- 7 June 2031Patent 8802142 drug product
- 7 December 2031Patent 8802142*PED
Tablet, Extended Release, Oral
Four or more generic makers listed
Brand listed as marketed: Keppra Xr. 10 generic makers with 20 generic products listed as marketed; the first generic approval is dated 12 September 2011.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Actavis Laboratories Fl Inc | 12 September 2011 | 2 |
| Apotex Inc | 12 September 2011 | 2 |
| Lupin Limited | 12 September 2011 | 2 |
| Torrent Pharmaceuticals Ltd | 29 May 2012 | 2 |
| Prinston Pharmaceutical Inc | 21 May 2015 | 2 |
| Anda Repository Llc | 23 February 2016 | 2 |
| Aiping Pharmaceutical Inc | 26 August 2016 | 2 |
| Hisun Pharmaceutical (Hangzhou) Co Ltd | 28 September 2017 | 2 |
| Yabao Pharmaceutical Co Ltd Beijing | 11 June 2020 | 2 |
| Sciegen Pharmaceuticals Inc | 27 November 2020 | 2 |
Patents and exclusivities still listed
- 17 September 2028Patent 7858122 drug product
Injectable, Intravenous
Four or more generic makers listed
Brand listed as marketed: Keppra and Levetiracetam In Sodium Chloride. 17 generic makers with 39 generic products listed as marketed; the first generic approval is dated 26 May 2010.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Xgen Pharmaceuticals Djb Inc | 5 August 2011 | 1 |
| Hikma Farmaceutica (Portugal) Sa | 13 October 2011 | 1 |
| Hospira Inc | 6 April 2012 | 1 |
| Sagent Pharmaceuticals Inc | 26 June 2013 | 1 |
| Fresenius Kabi Usa Llc | 13 August 2015 | 4 |
| Eugia Pharma Specialities Ltd | 1 February 2016 | 4 |
| Mylan Laboratories Ltd | 16 September 2016 | 4 |
| Gland Pharma Ltd | 25 October 2017 | 3 |
| Hainan Poly Pharmaceutical Co Ltd | 20 March 2018 | 1 |
| Micro Labs Ltd | 9 August 2019 | 1 |
| Nexus Pharmaceuticals Llc | 6 July 2020 | 3 |
| Prinston Pharmaceutical Inc | 28 March 2022 | 1 |
5 more makers are listed in the data.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Oral
Four or more generic makers listed
Brand listed as marketed: Keppra. 13 generic makers with 13 generic products listed as marketed; the first generic approval is dated 15 January 2009.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Actavis Mid Atlantic Llc | 15 January 2009 | 1 |
| Aurobindo Pharma Ltd | 15 January 2009 | 1 |
| Bionpharma Inc | 16 January 2009 | 1 |
| Taro Pharmaceutical Industries Ltd | 10 February 2009 | 1 |
| Chartwell Molecular Holdings Llc | 3 April 2009 | 1 |
| Amneal Pharmaceuticals | 27 October 2009 | 1 |
| Ajenat Pharmaceuticals Llc | 30 September 2010 | 1 |
| Quagen Pharmaceuticals Llc | 11 April 2012 | 1 |
| Hetero Labs Ltd Unit Iii | 28 February 2013 | 1 |
| Alembic Pharmaceuticals Ltd | 9 May 2013 | 1 |
| Pharmaceutical Associates Inc | 4 June 2015 | 1 |
| Msn Laboratories Private Ltd | 15 July 2022 | 1 |
1 more makers are listed in the data.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, For Suspension, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Spritam. No generic is listed as marketed.
Patents and exclusivities still listed
- 14 March 2034Patent 9339489 drug product
- 14 March 2034Patent 9669009
- 14 March 2034Patent 11160786 drug product
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.