Keppra(levetiracetam)
Keppra, Levetiracetam, Matever, Spritam (levetiracetam) is a small molecule pharmaceutical. Levetiracetam was first approved as Keppra on 1999-11-30. It is used to treat epilepsy, juvenile myoclonic epilepsy, partial epilepsies, and tonic-clonic epilepsy in the USA. It has been approved in Europe to treat epilepsy. The pharmaceutical is active against synaptic vesicle glycoprotein 2A.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Keppra, Levetiracetam, Spritam (discontinued: Elepsia, Levetiracetam)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levetiracetam
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SPRITAM | Aprecia Pharmaceuticals | N-207958 RX | 2015-07-31 | 4 products, RLD, RS |
| LEVETIRACETAM IN SODIUM CHLORIDE | HQ Specialty Pharma | N-202543 RX | 2011-11-09 | 3 products, RLD, RS |
| KEPPRA | UCB | N-021035 RX | 1999-11-30 | 4 products, RLD |
| KEPPRA | UCB | N-021505 RX | 2003-07-15 | 1 products, RLD, RS |
| KEPPRA | UCB | N-021872 RX | 2006-07-31 | 1 products, RLD, RS |
| KEPPRA XR | UCB | N-022285 RX | 2008-09-12 | 2 products, RLD |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elepsia xr | New Drug Application | 2021-01-06 |
| elepsia xr 1000 mg elepsia xr 1500 mg | New Drug Application | 2024-03-25 |
| keppra | New Drug Application | 2024-04-22 |
| keppra keppra | 2009-05-11 | |
| keppra xr | 2009-05-21 | |
| levetiracetam | ANDA | 2025-04-08 |
| levetiracetam er | ANDA | 2025-01-22 |
| levetiracetam extended-release | ANDA | 2009-08-15 |
| levetiracetam in sodium chloride | ANDA | 2024-04-30 |
| levetiracetam levetiracetam | ANDA | 2024-08-01 |
Show 3 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Levetiracetam, Spritam, Aprecia Pharms | |||
| 9339489 | 2034-03-14 | DP | U-1850 |
| 9669009 | 2034-03-14 | U-1850, U-2021, U-2022 | |
| 11160786 | 2034-03-14 | DP | |
| Levetiracetam, Keppra, Ucb Inc | |||
| 8802142 | 2031-06-07 | DP | |
| Levetiracetam, Keppra Xr, Ucb Inc | |||
| 7858122 | 2028-09-17 | DP | |
| Levetiracetam, Elepsia Xr, Tripoint | |||
| 8431156 | 2027-10-31 | DP | |
| 8470367 | 2027-10-31 | DP | |
| 8163306 | 2027-09-03 | DP | |
| 8425938 | 2026-02-22 | DP | |
| 8535717 | 2026-02-22 | DP | |
HCPCS
Code | Description |
|---|---|
| J1953 | Injection, levetiracetam, 10 mg |
Clinical
Clinical Trials
286 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 2 | 10 | 24 | 10 | 6 | 51 |
| Seizures | D012640 | — | G40.4 | — | 6 | 12 | 1 | 2 | 20 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | 2 | 6 | 5 | — | 13 |
| Dyskinesias | D020820 | — | G24 | — | 3 | 1 | 1 | — | 5 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | 1 | — | 4 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | — | 1 | — | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 1 | 1 | 1 | — | 3 |
| Syndrome | D013577 | — | — | — | 1 | — | 1 | — | 2 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | — | 1 | — | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 1 | — | 1 |
Show 10 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Generalized epilepsy | D004829 | — | — | — | — | 6 | — | — | 6 |
| Tardive dyskinesia | D000071057 | — | G24.01 | — | 1 | 1 | — | — | 2 |
| Panic disorder | D016584 | EFO_0004262 | F41.0 | — | 1 | 1 | — | — | 2 |
| Tonic-clonic epilepsy | D004830 | EFO_0007262 | — | — | — | 2 | — | — | 2 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | 1 | — | — | 1 |
| Compulsive personality disorder | D003193 | — | F60.5 | — | 1 | 1 | — | — | 1 |
| Reflex epilepsy | D020195 | EFO_1001146 | — | — | 1 | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Post-traumatic epilepsy | D004834 | — | — | — | — | 1 | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 2 | — | — | — | 2 |
| Social phobia | D000072861 | EFO_1001917 | F40.1 | — | 2 | — | — | — | 2 |
| Absence epilepsy | D004832 | — | G40.A | — | 1 | — | — | 1 | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
| Alcohol withdrawal seizures | D020270 | — | — | — | 1 | — | — | — | 1 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | — | — | — | 1 |
| Muscle spasticity | D009128 | — | — | — | 1 | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 1 | — | — | — | 1 |
| Muscular atrophy | D009133 | — | — | — | 1 | — | — | — | 1 |
Show 9 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | — | — | 1 | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | — | 1 | 1 |
| Premenstrual dysphoric disorder | D065446 | — | F32.81 | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 1 | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Levetiracetam |
| INN | levetiracetam |
| Description | Levetiracetam is a pyrrolidinone and carboxamide that is N-methylpyrrolidin-2-one in which one of the methyl hydrogens is replaced by an aminocarbonyl group, while another is replaced by an ethyl group (the S enantiomer). An anticonvulsant, it is used for the treatment of epilepsy in both human and veterinary medicine. It has a role as an anticonvulsant, an environmental contaminant and a xenobiotic. |
| Classification | Small molecule |
| Drug class | nootropic agents (learning, cognitive enhancers), piracetam type |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H](C(N)=O)N1CCCC1=O |
Identifiers
| PDB | — |
| CAS-ID | 102767-28-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1286 |
| ChEBI ID | 6437 |
| PubChem CID | 5284583 |
| DrugBank | DB01202 |
| UNII ID | 44YRR34555 (ChemIDplus, GSRS) |
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Levetiracetam
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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75,801 adverse events reported
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