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Drug ReportsLoratadine
Loratadine
Alavert, Claritin, Loratadine (loratadine) is a small molecule pharmaceutical. Loratadine was first approved as Claritin on 2002-11-27. It is used to treat allergic rhinitis perennial and urticaria in the USA. The pharmaceutical is active against histamine H1 receptor. In addition, it is known to target sodium-dependent neutral amino acid transporter B(0)AT2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Alavert, Claritin, Loratadine, Loratadine redidose (discontinued: Claritin, Loratadine)
Combinations
Claritin, Loratadine pseudoephedrine
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Loratadine
Tradename
Company
Number
Date
Products
CLARITINBayerN-019658 OTC2002-11-27
1 products, RLD, RS
CLARITIN HIVES RELIEFBayerN-019658 OTC2003-11-19
1 products, RLD, RS
CLARITINBayerN-020641 OTC2002-11-27
1 products, RLD, RS
CLARITIN REDITABSBayerN-020704 OTC2002-11-27
1 products, RLD, RS
CLARITIN HIVES RELIEF REDITABBayerN-020704 OTC2003-11-19
1 products, RLD, RS
CHILDREN'S CLARITINBayerN-021891 OTC2006-08-23
1 products, RLD
CLARITINBayerN-021891 OTC2018-11-21
1 products, RLD, RS
CLARITINBayerN-021952 OTC2008-06-16
1 products, RLD, RS
CLARITIN REDITABSBayerN-021993 OTC2006-12-12
1 products, RLD, RS
ALAVERTFoundation Consumer HealthcareN-021375 OTC2002-12-19
1 products
Show 1 marketed
Show 2 discontinued
Loratadine
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CLARITIN-DBayerN-019670 OTC2002-11-27
1 products, RLD, RS
CLARITIN-D 24 HOURBayerN-020470 OTC2002-11-27
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
24 / 7 life non-drowsy allergy reliefANDA2024-07-22
alavertNew Drug Application2025-01-09
all day allergy reliefANDA2024-12-19
allergyANDA2019-04-30
allergy and congestion reliefANDA2024-02-26
allergy congestion reliefANDA2024-02-27
allergy reliefANDA2025-04-08
allergy relief dANDA2024-03-12
allergy relief d 12ANDA2023-09-06
allergy relief loratadine 10mgANDA2020-06-16
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
sinusitisEFO_0007486D012852J32
asthmaEFO_0000270D001249J45
common coldEFO_0007214D003139J00
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AX: Other antihistamines for systemic use in atc
— R06AX13: Loratadine
HCPCS
No data
Clinical
Clinical Trials
103 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitisD065631—J30.9—11417
RhinitisD012220EFO_0008521J31—11417
Allergic rhinitis seasonalD006255EFO_0003956J30—112—4
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLoratadine
INNloratadine
Description
Loratadine is a benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders. It has a role as a geroprotector, a H1-receptor antagonist, an anti-allergic agent and a cholinergic antagonist. It is an ethyl ester, a N-acylpiperidine, a tertiary carboxamide, an organochlorine compound and a benzocycloheptapyridine. It is functionally related to a desloratadine.
Classification
Small molecule
Drug classtricyclic histaminic-H1 receptor antagonists, loratadine derivatives (formerly-tadine)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1
Identifiers
PDB—
CAS-ID79794-75-5
RxCUI—
ChEMBL IDCHEMBL998
ChEBI ID—
PubChem CID3957
DrugBankDB00455
UNII ID7AJO3BO7QN (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
SLC6A15
SLC6A15
Organism
Homo sapiens
Gene name
SLC6A15
Gene synonyms
B0AT2, NTT73, SBAT1
NCBI Gene ID
55117
Protein name
sodium-dependent neutral amino acid transporter B(0)AT2
Protein synonyms
homolog of rat orphan transporter v7-3, orphan sodium- and chloride-dependent neurotransmitter transporter NTT73, orphan transporter v7-3, Sodium- and chloride-dependent neurotransmitter transporter NTT73, Sodium-coupled branched-chain amino-acid transporter 1, sodium/chloride dependent neurotransmitter transporter Homo sapiens orphan neurotransmitter transporter NTT7, solute carrier family 6 (neurotransmitter transporter), member 15, solute carrier family 6 (neutral amino acid transporter), member 15, Solute carrier family 6 member 15, Transporter v7-3
Uniprot ID
Q9H9F5
Mouse ortholog
Slc6a15 (103098)
sodium-dependent neutral amino acid transporter B(0)AT2 (Q8BG16)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Loratadine
Total medical expenditures per year (USD, in millions)
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Loratadine
+
Pseudoephedrine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,328 documents
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Safety
Black-box Warning
Black-box warning for: Calmicid ac
Adverse Events
Top Adverse Reactions
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45,812 adverse events reported
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