Tools / Drug approvals and letters / Drugs Levetiracetam Treats partial-onset seizures. Sold as Keppra, Keppra Xr, Levetiracetam In Sodium Chloride, Elepsia Xr, Spritam. Every FDA application for this active ingredient: 7 branded and 106 generic.
As of Nov 15, 2026, FDA lists 113 applications for Levetiracetam (sold as Keppra, Keppra Xr, Levetiracetam In Sodium Chloride and others), first approved Nov 30, 1999, with 18 new uses approved and 3 published complete response letters.
First approved : Nov 30, 1999 Applications : 113 New uses approved : 18 Complete response letters : 3 Medicare spending, 2025 : $264M First approved in the EU : Sep 29, 2000 First approved in Japan : Jul 23, 2010
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Levetiracetam Part D $156M +9% 831,390 Keppra Part D $68.2M -5% 4,969 Keppra XR Part D $23.8M -5% 1,845 Levetiracetam ER Part D $14.4M +12% 41,870 Spritam Part D $1.1M -28% 292 Keppra Part B $2K -35% 115 Roweepra Part D $1K +45% 0
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change LEVETIRACETAM 1,000 MG TABLET: $0.164 per unit Generic · +2% in a year LEVETIRACETAM 100 MG/ML SOLN: $0.030 per ML Generic · -3% in a year LEVETIRACETAM 250 MG TABLET: $0.057 per unit Generic · -4% in a year LEVETIRACETAM 500 MG TABLET: $0.072 per unit Generic · -6% in a year LEVETIRACETAM 750 MG TABLET: $0.111 per unit Generic · -4% in a year LEVETIRACETAM ER 500 MG TABLET: $0.177 per unit Generic · -1% in a year LEVETIRACETAM ER 750 MG TABLET: $0.237 per unit Generic · -11% in a year KEPPRA 1,000 MG TABLET: $19.87 per unit Brand · +2% in a year KEPPRA 100 MG/ML ORAL SOLN: $1.92 per ML Brand · +2% in a year KEPPRA 250 MG TABLET: $8.08 per unit Brand · +2% in a year KEPPRA 500 MG TABLET: $9.92 per unit Brand · +3% in a year KEPPRA 750 MG TABLET: $13.45 per unit Brand · +3% in a year FDA Drug Safety Communications One communication since 2020 that name this drug; see all communications Approvals in the EU (EMA) First approved in the EU 10 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals Levetiracetam Hospira, generic Pfizer Europe MA EEIG · Jan 7, 2014 Levetiracetam Sun, generic Sun Pharmaceutical Industries Europe B.V. · Dec 14, 2011 Levetiracetam Actavis Group, generic Actavis Group PTC ehf · Dec 4, 2011 Levetiracetam Actavis, generic Actavis Group PTC ehf · Oct 3, 2011 Matever, generic Pharmathen S.A. · Oct 3, 2011 Levetiracetam Accord, generic Accord Healthcare S.L.U. · Oct 3, 2011 Levetiracetam ratiopharm, generic ratiopharm GmbH · Aug 26, 2011 Levetiracetam Teva, generic Teva B.V. · Aug 25, 2011 Approvals in Japan (PMDA) First approved in Japan 128 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals E Keppra Drugs with a new additional pediatric dosage indicated for the treatment of partial seizures (including secondary generalized seizures) in patients with… · UCB Japan Co., Ltd. · Jun 26, 2023 E Keppra A drug with a new indication and a new dosage for the treatment of status epilepticus. · UCB Japan Co., Ltd. · Dec 23, 2022 E Keppra Drugs with a new additional indication for use as an adjunctive therapy with other antiepileptic drugs to treat tonic-clonic seizures in patients with… · UCB Japan Co., Ltd. · Feb 29, 2016 E Keppra Drugs with a revised indication and a new dosage for the treatment of partial seizure in patients with epilepsy (including secondary generalized seizure). · UCB Japan Co., Ltd. · Feb 20, 2015 E Keppra, new approval A drug with a new route of administration indicated for use as an adjunctive therapy with other antiepileptic drugs to treat partial seizure (including… · UCB Japan Co., Ltd. · Jul 4, 2014 E Keppra, new approval A drug with a new additional pediatric dosage in an additional dosage form indicated for use as an adjunctive therapy with other antiepileptic drugs to… · UCB Japan Co., Ltd. · Jun 28, 2013 E Keppra Drugs with a new additional pediatric dosage indicated for use as an adjunctive therapy with other antiepileptic drugs to treat partial seizures (including… · UCB Japan Co., Ltd. · May 31, 2013 E Keppra, new ingredient Drugs with a new active ingredient indicated for use as an adjunctive therapy with other antiepileptic drugs to treat partial seizures (including secondary… · UCB Japan Co., Ltd. · Jul 23, 2010 Clinical Trials 41 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics · Chulalongkorn University — Recruiting Nov 5, 2026 Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection · Alexandria University Not applicable Not yet recruiting Oct 27, 2026 Metabolically Fit CD19 CAR T Cells With CD34 Selection Markers in Adults With CD19-Positive B-Cell Acute Lymphocytic Leukemia CD19 Positive, B-ALL · Medical University of South Carolina Phase 1 Not yet recruiting Oct 26, 2026 Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma Glioblastoma · Tianjin Medical University General Hospital Phase 2 Not yet recruiting Aug 11, 2026 Levetiracetam Three Times Daily in Epilepsy Epilepsy · Waad Alkathiri Phase 3 Recruiting Mar 24, 2026 Levetiracetam for Persons at Risk for Alzheimer's Disease Hippocampal Hyperactivation, Prodromal Alzheimer Disease · Sunnybrook Health Sciences Centre Phase 2 Recruiting Mar 17, 2026 Efficacy of Prophylactic Levetiracetam for Improving Functional Outcome in the Acute Phase of Intracerebral Haemorrhage: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial Spontaneous Intracerebral Hemorrhage · Hospices Civils de Lyon Phase 3 Not yet recruiting Jan 13, 2026 Treatment of Seizures in Neonate With HIE Neonatal Seizures, HIE - Hypoxic - Ischemic Encephalopathy · Mansoura University Phase 4 Not yet recruiting Dec 16, 2025
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Nov 30, 1999 Keppra NDA 21035 · New molecular entity Ucb Inc54 Marketed Jul 15, 2003 Keppra NDA 21505 · New dosage form Ucb Inc28 Marketed Jul 31, 2006 Keppra NDA 21872 · New dosage form Ucb Inc18 Marketed Sep 12, 2008 Keppra Xr NDA 22285 · New dosage form Ucb Inc20 Marketed Nov 4, 2008 Levetiracetam ANDA 76919 Mylan15 Marketed Jan 15, 2009 Levetiracetam ANDA 76920 Pharmazone4 Marketed Jan 15, 2009 Levetiracetam ANDA 77324 Fosun Pharma6 Discontinued Jan 15, 2009 Levetiracetam ANDA 78101 Teva Pharms7 Discontinued Jan 15, 2009 Levetiracetam ANDA 78154 Lupin16 Marketed Jan 15, 2009 Levetiracetam ANDA 78234 Invagen Pharms1 Discontinued Jan 15, 2009 Levetiracetam ANDA 78526 Orbion Pharms15 Marketed Jan 15, 2009 Levetiracetam ANDA 78797 Watson Labs Inc1 Discontinued Jan 15, 2009 Levetiracetam ANDA 78858 Torrent Pharms20 Marketed Jan 15, 2009 Levetiracetam ANDA 78904 Pharmazone4 Marketed Jan 15, 2009 Levetiracetam ANDA 78976 Actavis Mid Atlantic10 Marketed Jan 15, 2009 Levetiracetam ANDA 78993 Aurobindo Pharma16 Marketed Jan 15, 2009 Levetiracetam ANDA 79042 Ingenus Pharms LLC4 Marketed Jan 15, 2009 Levetiracetam ANDA 79107 Tolmar7 Discontinued Jan 15, 2009 Levetiracetam ANDA 90025 Lupin16 Marketed Jan 15, 2009 Levetiracetam ANDA 79063 Aurobindo Pharma16 Marketed Jan 15, 2009 Levetiracetam ANDA 78042 Strides Pharma7 Discontinued Jan 15, 2009 Levetiracetam ANDA 78582 Strides Pharma11 Discontinued Jan 16, 2009 Levetiracetam ANDA 79120 Bionpharma13 Marketed Feb 10, 2009 Levetiracetam ANDA 78106 Prinston Inc11 Marketed Feb 10, 2009 Levetiracetam ANDA 78731 Mylan0 Discontinued Feb 10, 2009 Levetiracetam ANDA 78774 Taro6 Marketed Mar 2, 2009 Levetiracetam ANDA 77408 Actavis Labs Fl Inc0 Discontinued Mar 13, 2009 Levetiracetam ANDA 78869 Novax6 Marketed Mar 20, 2009 Levetiracetam ANDA 77319 Oxford Pharms3 Marketed Apr 3, 2009 Levetiracetam ANDA 90263 Chartwell Molecular12 Marketed Apr 29, 2009 Levetiracetam ANDA 78918 Zydus Pharms USA Inc9 Marketed Oct 27, 2009 Levetiracetam ANDA 90992 Amneal Pharms11 Marketed Dec 8, 2009 Levetiracetam ANDA 90261 Mylan14 Marketed Feb 1, 2010 Levetiracetam ANDA 78960 Taro5 Discontinued Mar 3, 2010 Levetiracetam ANDA 90028 Pharmobedient Cnsltg0 Discontinued May 26, 2010 Levetiracetam ANDA 90813 Fresenius Kabi USA2 Discontinued Jun 16, 2010 Levetiracetam ANDA 90754 Sun Pharm Inds Ltd0 Discontinued Jul 28, 2010 Levetiracetam ANDA 90767 Rising13 Marketed Aug 5, 2010 Levetiracetam ANDA 90484 Orbion Pharms12 Marketed Sep 30, 2010 Levetiracetam ANDA 90461 Ajenat Pharms3 Marketed Oct 8, 2010 Levetiracetam ANDA 90515 Hetero Labs Ltd Iii7 Marketed Nov 5, 2010 Levetiracetam ANDA 90906 Lotus Pharm Co Ltd4 Discontinued Dec 14, 2010 Levetiracetam ANDA 91491 Zhejiang Jingxin6 Marketed Feb 14, 2011 Levetiracetam ANDA 90843 Accord Hlthcare10 Discontinued Jun 14, 2011 Levetiracetam ANDA 201293 Chartwell Rx2 Marketed Aug 5, 2011 Levetiracetam ANDA 90187 Apotex Inc9 Discontinued Aug 5, 2011 Levetiracetam ANDA 91485 Xgen Pharms2 Marketed Aug 18, 2011 Levetiracetam ANDA 90511 Mpp Pharma1 Discontinued Sep 12, 2011 Levetiracetam ANDA 91093 Actavis Labs Fl Inc1 Marketed Sep 12, 2011 Levetiracetam ANDA 91285 Sun Pharm Industries2 Discontinued Sep 12, 2011 Levetiracetam ANDA 91399 Lupin Ltd14 Marketed Sep 12, 2011 Levetiracetam ANDA 91557 Actavis Elizabeth7 Discontinued Sep 12, 2011 Levetiracetam ANDA 91291 Chartwell Rx6 Discontinued Sep 12, 2011 Levetiracetam ANDA 91261 Apotex Inc11 Marketed Sep 12, 2011 Levetiracetam ANDA 91430 Teva Pharms5 Discontinued Oct 4, 2011 Levetiracetam ANDA 91360 Ph Health0 Discontinued Oct 13, 2011 Levetiracetam ANDA 90981 Hikma Farmaceutica9 Marketed Oct 17, 2011 Levetiracetam ANDA 90893 Lupin Ltd12 Discontinued Nov 9, 2011 Levetiracetam In Sodium Chloride NDA 202543 · New dosage form Hq Spclt Pharma12 Marketed Dec 19, 2011 Levetiracetam ANDA 200475 Aurobindo Pharma USA7 Discontinued Jan 31, 2012 Levetiracetam ANDA 202143 Am Regent3 Discontinued Feb 28, 2012 Levetiracetam ANDA 90601 Hikma5 Discontinued Apr 6, 2012 Levetiracetam ANDA 202869 Hospira Inc7 Marketed Apr 11, 2012 Levetiracetam ANDA 90079 Quagen5 Marketed May 25, 2012 Levetiracetam ANDA 201464 Alicora3 Discontinued May 29, 2012 Levetiracetam ANDA 91338 Torrent Pharms Ltd8 Marketed Jul 20, 2012 Levetiracetam ANDA 202533 Prinston4 Discontinued Aug 27, 2012 Levetiracetam ANDA 202524 Rouses Point Pharms0 Discontinued Nov 1, 2012 Levetiracetam ANDA 91668 Sandoz3 Discontinued Feb 28, 2013 Levetiracetam ANDA 203052 Hetero Labs Ltd Iii8 Marketed May 9, 2013 Levetiracetam ANDA 203067 Alembic0 Marketed Jun 26, 2013 Levetiracetam ANDA 91627 Sagent Pharms8 Marketed Sep 9, 2013 Levetiracetam ANDA 203059 Sun Pharm11 Discontinued Feb 25, 2015 Levetiracetam ANDA 202958 Apotex9 Discontinued May 21, 2015 Levetiracetam ANDA 203468 Prinston7 Marketed Jun 4, 2015 Levetiracetam ANDA 201157 Pharm Assoc7 Marketed Jul 31, 2015 Spritam NDA 207958 · New dosage form Aprecia Pharms9 Marketed Aug 13, 2015 Levetiracetam ANDA 90876 Fresenius Kabi USA4 Marketed Sep 4, 2015 Levetiracetam ANDA 202167 Adaptis5 Discontinued Dec 16, 2015 Levetiracetam ANDA 205102 China Resources3 Discontinued Feb 1, 2016 Levetiracetam ANDA 204312 Eugia Pharma6 Marketed Feb 23, 2016 Levetiracetam ANDA 204511 Anda Repository0 Marketed Jun 2, 2016 Levetiracetam ANDA 206838 Jubilant Generics1 Discontinued Jun 6, 2016 Levetiracetam ANDA 202095 Lotus Pharm Co Ltd6 Discontinued Aug 26, 2016 Levetiracetam ANDA 204754 Aiping Pharm Inc2 Marketed Sep 16, 2016 Levetiracetam ANDA 203308 Mylan Labs Ltd6 Marketed Jan 4, 2017 Levetiracetam In Sodium Chloride ANDA 207160 Eugia Pharma5 Marketed Sep 28, 2017 Levetiracetam ANDA 207175 Hisun Pharm Hangzhou5 Marketed Oct 25, 2017 Levetiracetam In Sodium Chloride ANDA 206880 Gland4 Marketed Mar 20, 2018 Levetiracetam ANDA 209781 Hainan Poly Pharm2 Marketed May 4, 2018 Levetiracetam ANDA 209934 Epic Pharma LLC2 Discontinued Dec 20, 2018 Elepsia Xr NDA 204417 · New formulation or manufacturer Tripoint2 Discontinued Aug 9, 2019 Levetiracetam ANDA 211954 Micro Labs4 Marketed Jun 11, 2020 Levetiracetam ANDA 212688 Yabao Pharm1 Marketed Jul 6, 2020 Levetiracetam In Sodium Chloride ANDA 213532 Nexus1 Marketed Nov 27, 2020 Levetiracetam ANDA 205130 Sciegen Pharms2 Marketed Mar 28, 2022 Levetiracetam ANDA 209474 Prinston1 Marketed May 27, 2022 Levetiracetam ANDA 216375 Alkem Labs Ltd1 Marketed May 27, 2022 Levetiracetam ANDA 215069 Sciegen Pharms3 Marketed Jul 15, 2022 Levetiracetam ANDA 214757 Msn2 Marketed Oct 7, 2022 Levetiracetam ANDA 214815 Msn1 Marketed Nov 15, 2022 Levetiracetam ANDA 215980 Msn0 Marketed Jan 31, 2023 Levetiracetam In Sodium Chloride ANDA 208619 Fresenius Kabi USA0 Marketed Jun 13, 2023 Levetiracetam ANDA 217878 Granules2 Discontinued Oct 2, 2023 Levetiracetam In Sodium Chloride ANDA 217059 Baxter Hlthcare Corp1 Marketed Nov 20, 2023 Levetiracetam ANDA 214673 Strides Pharma2 Discontinued Feb 12, 2024 Levetiracetam In Sodium Chloride ANDA 211356 Hikma1 Marketed Feb 27, 2024 Levetiracetam In Sodium Chloride ANDA 209705 B Braun Medical1 Marketed Jan 16, 2025 Levetiracetam In Sodium Chloride ANDA 219562 Caplin0 Marketed Nov 21, 2025 Levetiracetam ANDA 218080 Adaptis0 Marketed Dec 2, 2025 Levetiracetam ANDA 215465 Knack0 Discontinued May 8, 2026 Levetiracetam In Sodium Chloride ANDA 218364 Mylan Labs Ltd0 Marketed Aug 6, 2026 Levetiracetam ANDA 208458 Baxter Hlthcare Corp0 Marketed
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Complete Response Letters FDA's published letters for these applications Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA