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Drug ReportsOlanzapine
Zyprexa(olanzapine)
Lybalvi, Olanzapine, Olazax, Zalasta, Zypadhera, Zyprexa (olanzapine) is a small molecule pharmaceutical. Olanzapine was first approved as Zyprexa on 1996-09-27. It is used to treat bipolar disorder, psychotic disorders, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat bipolar disorder and schizophrenia. The pharmaceutical is active against 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2C, and D(2) dopamine receptor. In addition, it is known to target alpha-1A adrenergic receptor, 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1F, 5-hydroxytryptamine receptor 7, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 1D, alpha-1D adrenergic receptor, histamine H1 receptor, 5-hydroxytryptamine receptor 1E, and 5-hydroxytryptamine receptor 1A.
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FDA Novel Drug Approvals 2021
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Olanzapine, Zyprexa, Zyprexa relprevv, Zyprexa zydis (discontinued: Olanzapine)
Combinations
Lybalvi, Olanzapine fluoxetine (discontinued: Symbyax)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluoxetine hydrochloride
+
Olanzapine
Tradename
Company
Number
Date
Products
SYMBYAXEli LillyN-021520 DISCN2003-12-24
5 products, RLD
Hide discontinued
Olanzapine
Tradename
Company
Number
Date
Products
ZYPREXACHEPLAPHARM ArzneimittelN-021253 RX2004-03-29
1 products, RLD, RS
ZYPREXACHEPLAPHARM ArzneimittelN-020592 RX1996-09-30
6 products, RLD
ZYPREXA ZYDISCHEPLAPHARM ArzneimittelN-021086 RX2000-04-06
4 products, RLD
Olanzapine
+
Samidorphan l-malate
Tradename
Company
Number
Date
Products
LYBALVIAlkermesN-213378 RX2021-05-28
4 products, RLD
Olanzapine pamoate
Tradename
Company
Number
Date
Products
ZYPREXA RELPREVVCHEPLAPHARM ArzneimittelN-022173 RX2009-12-11
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lybalviNew Drug Application2025-02-28
olanzapineANDA2025-09-20
olanzapine and fluoxetineANDA2025-03-27
symbyaxNew Drug Application2025-01-22
zyprexaNew Drug Application2025-07-25
zyprexa zyprexaNew Drug Application2025-01-08
zyprexa zyprexaNew Drug Application2025-01-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
schizophreniaEFO_0000692D012559F20
psychotic disorders—D011618F20.81
bipolar disorderEFO_0000289D001714F30.9
schizophrenia spectrum and other psychotic disorders—D019967—
bulimia—D002032F50.2
panic disorderEFO_0004262D016584F41.0
major depressive disorderEFO_0003761D003865F22
obsessive-compulsive disorderEFO_0004242D009771F42
Agency Specific
FDA
EMA
Expiration
Code
OLANZAPINE / SAMIDORPHAN L-MALATE, LYBALVI, ALKERMES INC
2026-05-28NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Olanzapine / Samidorphan L-Malate, Lybalvi, Alkermes Inc
117074662041-11-12DP
87789602032-02-13U-3136, U-3137
91198482031-08-30DP
91269772031-08-23DPU-3136, U-3137
95172352031-08-23U-3138, U-3139
103000542031-08-23DPU-3140, U-3141
107167852031-08-23U-3136, U-3137
111855412031-08-23U-3140
112414252031-08-23U-3137
113511662031-08-23U-3140, U-3141
117938052031-08-23U-3734
72622982025-11-23DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AH: Diazepines, oxazepines, thiazepines and oxepines antipsychotic drugs
— N05AH03: Olanzapine
— N05AH53: Olanzapine and samidorphan
HCPCS
Code
Description
J2358
Injection, olanzapine, long-acting, 1 mg
S0166
Injection, olanzapine, 2.5 mg
Clinical
Clinical Trials
542 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20128——11
Bipolar disorderD001714EFO_0000289F30.91—4——5
Psychotic disordersD011618—F20.81——2——2
Body weightD001835EFO_0004338———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.1—1———1
Alcohol drinkingD000428EFO_0004329——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614E88.8191————1
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOlanzapine
INNolanzapine
Description
Olanzapine, sold under the brand name Zyprexa among others, is an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder. For schizophrenia, it can be used for both new-onset disease and long-term maintenance. It is taken by mouth or by injection into a muscle.
Classification
Small molecule
Drug classtricyclic compounds
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Identifiers
PDB—
CAS-ID132539-06-1
RxCUI—
ChEMBL IDCHEMBL715
ChEBI ID7735
PubChem CID4585
DrugBankDB00334
UNII IDN7U69T4SZR (ChemIDplus, GSRS)
Target
Agency Approved
HTR2A
HTR2A
HTR2C
HTR2C
DRD2
DRD2
Organism
Homo sapiens
Gene name
HTR2A
Gene synonyms
HTR2
NCBI Gene ID
3356
Protein name
5-hydroxytryptamine receptor 2A
Protein synonyms
5-HT2 receptor, 5-hydroxytryptamine (serotonin) receptor 2A, G protein-coupled, serotonin 5-HT-2A receptor, Serotonin receptor 2A
Uniprot ID
Q5T8C0
Mouse ortholog
Htr2a (15558)
5-hydroxytryptamine receptor 2A (P35363)
Alternate
ADRA1A
ADRA1A
HTR1B
HTR1B
HTR1F
HTR1F
HTR7
HTR7
HTR6
HTR6
HTR1D
HTR1D
ADRA1D
ADRA1D
HRH1
HRH1
HTR1E
HTR1E
HTR1A
HTR1A
Organism
Homo sapiens
Gene name
ADRA1A
Gene synonyms
ADRA1C
NCBI Gene ID
148
Protein name
alpha-1A adrenergic receptor
Protein synonyms
Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor
Uniprot ID
Q9UD67
Mouse ortholog
Adra1a (11549)
alpha-1A adrenergic receptor (Q8BV77)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Lybalvi – Alkermes
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Zyprexa – Eli Lilly
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Estimated US medical usage
Olanzapine
+
Fluoxetine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Olanzapine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,437 documents
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Safety
Black-box Warning
Black-box warning for: Lybalvi, Olanzapine, Olanzapine and fluoxetine, Symbyax, Zyprexa, Zyprexa zyprexa, Zyprexa zyprexa
Adverse Events
Top Adverse Reactions
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83,251 adverse events reported
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