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Drug ReportsPaliperidone
Invega(paliperidone)
Byannli, Erzofri, Invega, Paliperidone, Trevicta, Xeplion (paliperidone) is a small molecule pharmaceutical. Paliperidone was first approved as Invega on 2006-12-19. It is used to treat bipolar disorder, depressive disorder, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat psychotic disorders and schizophrenia.
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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
Invega, Invega hafyera, Invega sustenna, Paliperidone (discontinued: Invega, Paliperidone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Paliperidone
Tradename
Company
Number
Date
Products
INVEGAJohnson & JohnsonN-021999 RX2006-12-19
3 products, RLD
Show 1 discontinued
Paliperidone palmitate
Tradename
Company
Number
Date
Products
INVEGA TRINZAJohnson & JohnsonN-207946 RX2015-05-18
4 products, RLD, RS
INVEGA HAFYERAJohnson & JohnsonN-207946 RX2021-08-30
2 products, RLD
INVEGA SUSTENNAJohnson & JohnsonN-022264 RX2009-07-31
5 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
invegaNew Drug Application2023-08-23
invega hafyeraNew Drug Application2024-09-18
invega sustennaNew Drug Application2024-09-18
invega trinzaNew Drug Application2024-09-18
paliperidoneANDA2024-10-10
paliperidone palmitateExport only2024-01-09
Agency Specific
FDA
EMA
Expiration
Code
PALIPERIDONE PALMITATE, INVEGA HAFYERA, JANSSEN PHARMS
2024-08-30NS
PALIPERIDONE PALMITATE, INVEGA TRINZA, JANSSEN PHARMS
2024-08-30NS
Patent Expiration
Patent
Expires
Flag
FDA Information
Paliperidone Palmitate, Invega Hafyera, Janssen Pharms
116666972041-11-24U-3626
113049512041-05-07U-3349
113247512041-05-07U-3359
101436932036-04-05U-2457, U-2458
Paliperidone Palmitate, Invega Sustenna, Janssen Pharms
94399062031-01-26U-543, U-1901, U-2757, U-2758
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05A: Antipsychotics
N05AX: Other antipsychotics in atc
N05AX13: Paliperidone
HCPCS
Code
Description
J2426
Injection, paliperidone palmitate extended release, 1 mg
Clinical
Clinical Trials
211 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F204015504830180
Psychotic disordersD011618F20.81103813841
Mental disordersD001523EFO_0000677F91.93144314
Bipolar disorderD001714EFO_0000289F30.9342514
RecurrenceD0120085128
Schizophrenia spectrum and other psychotic disordersD0199672226
DepressionD003863F33.91135
Depressive disorderD003866EFO_1002014F32.A123
Weight gainD015430HP_0004324112
Drug therapyD0043581112
Show 20 more
Indications Phases 3
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Schizotypal personality disorderD012569F2111
ImmunoassayD00711811
Healthy volunteers/patients11
Central nervous system diseasesD002493HP_0002011G96.911
Nervous system diseasesD009422G00-G9911
EpilepsyD004827EFO_0000474G40.911
Renal insufficiencyD051437HP_0000083N1911
Hepatic insufficiencyD04855011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.911
Type 2 diabetes mellitusD003924EFO_0001360E1111
EmergenciesD00463011
Medication adherenceD055118EFO_000634411
DelusionsD003702HP_000074611
Paranoid schizophreniaD012563F20.011
Breast feedingD00194211
PregnancyD011247EFO_0002950Z33.111
Periodontal diseasesD010510K05.611
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePaliperidone
INNpaliperidone
Description
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one is a member of the class of pyridopyrimidines that is 9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2. It is a member of 1,2-benzoxazoles, a heteroarylpiperidine, an organofluorine compound, a pyridopyrimidine and a secondary alcohol.
Classification
Small molecule
Drug classantipsychotics (risperidone type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Identifiers
PDB
CAS-ID1020719-55-4
RxCUI
ChEMBL IDCHEMBL1621
ChEBI ID83804
PubChem CID115237
DrugBankDB01267
UNII ID838F01T721 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Invega Alkermes
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Invega Johnson & Johnson
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Estimated US medical usage
Paliperidone
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 4,719 documents
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Safety
Black-box Warning
Black-box warning for: Invega, Invega hafyera, Invega sustenna, Invega trinza, Paliperidone
Adverse Events
Top Adverse Reactions
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49,314 adverse events reported
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