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AboutPricing
Drug ReportsClarithromycin
Clarithromycin
/ Clarithromycin /, Clarithromycin, Omeclamox-pak, Voquezna Triple (clarithromycin) is a small molecule pharmaceutical. Clarithromycin was first approved as Biaxin on 1991-10-31. It is used to treat bacterial infections, bronchitis, chlamydia infections, duodenal ulcer, and haemophilus infections amongst others in the USA. The pharmaceutical is active against androgen receptor.
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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
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
stomatognathic diseasesD009057
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Clarithromycin (discontinued: Biaxin, Clarithromycin)
Combinations
Lansoprazole, amoxicillin clarithromycin, Voquezna triple (discontinued: Lansoprazole, amoxicillin clarithromycin, Omeclamox-pak, Prevpac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clarithromycin
Tradename
Company
Number
Date
Products
BIAXINAbbVieN-050662 DISCN1991-10-31
2 products, RLD
BIAXINAbbVieN-050698 DISCN1993-12-23
3 products, RLD
BIAXIN XLAbbVieN-050775 DISCN2000-03-03
1 products, RLD
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Amoxicillin
+
Clarithromycin
+
Lansoprazole
Tradename
Company
Number
Date
Products
PREVPAC (COPACKAGED)TakedaN-050757 DISCN1997-12-02
1 products, RLD
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Amoxicillin
+
Clarithromycin
+
Omeprazole
Tradename
Company
Number
Date
Products
OMECLAMOX-PAKCumberland PharmaceuticalsN-050824 DISCN2011-02-08
1 products, RLD
Hide discontinued
Amoxicillin
+
Clarithromycin
+
Vonoprazan fumarate
Tradename
Company
Number
Date
Products
VOQUEZNA TRIPLE PAKPhathom PharmaceuticalsN-215152 RX2022-05-03
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
biaxinNew Drug Application2012-02-22
clarithromycinANDA2024-09-01
clarithromycin clarithromycinANDA2018-02-14
clarithromycin extended release2008-08-08
lansoprazole, amoxicillin, clarithromycinANDA2024-01-23
omeclamox-pakNew Drug Application2023-08-17
prevpacNew Drug Application2010-03-15
voquezna dual pak voquezna triple pakNew Drug Application2024-08-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sinusitisEFO_0007486D012852J32
nontuberculous mycobacterium infectionsEFO_0007461D009165A31.9
otitis mediaEFO_0004992D010033H66.9
bacterial infections—D001424A49
infectious skin diseases—D012874—
mycoplasma pneumoniaEFO_0007387D011019J15.7
chlamydia infectionsEFO_0007205D002690A74.9
helicobacter infectionsEFO_1000961D016481—
bronchitis—D001991J40
duodenal ulcerEFO_0004607D004381K26
Show 17 more
Agency Specific
FDA
EMA
Expiration
Code
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM
2032-05-03GAIN
2027-05-03NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Amoxicillin / Clarithromycin / Vonoprazan Fumarate, Voquezna Triple Pak, Phathom
91864112030-08-11DP
79774882028-08-11DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD04: Pantoprazole, amoxicillin and clarithromycin
— A02BD05: Omeprazole, amoxicillin and clarithromycin
— A02BD06: Esomeprazole, amoxicillin and clarithromycin
— A02BD07: Lansoprazole, amoxicillin and clarithromycin
— A02BD09: Lansoprazole, clarithromycin and tinidazole
— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole
— A02BD12: Rabeprazole, amoxicillin and clarithromycin
— A02BD14: Vonoprazan, amoxicillin and clarithromycin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01F: Macrolides, lincosamides and streptogramins
— J01FA: Macrolides
— J01FA09: Clarithromycin
HCPCS
No data
Clinical
Clinical Trials
519 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
GastritisD005756EFO_0000217K29.72—1—14
Stomach ulcerD013276—K25——1—12
Duodenal ulcerD004381EFO_0004607K26——1—12
UlcerD014456MPATH_579———2——2
InfectionsD007239EFO_0000544———1——1
Helicobacter infectionsD016481EFO_1000961———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.011———1
Plasma cell neoplasmsD054219——11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphoma marginal zoneD018442—C88.4————11
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3————11
Thrombocytopenic purpuraD011696——————11
PurpuraD011693HP_0000979D69.2————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameClarithromycin
INNclarithromycin
Description
Clarithromycin is the 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis. It has a role as an antibacterial drug, a protein synthesis inhibitor, an environmental contaminant and a xenobiotic.
Classification
Small molecule
Drug classantibiotics (Streptomyces strain)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O
Identifiers
PDB—
CAS-ID81103-11-9
RxCUI—
ChEMBL IDCHEMBL1741
ChEBI ID3732
PubChem CID84029
DrugBankDB01211
UNII IDH1250JIK0A (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
367
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Q9UD95
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Clarithromycin
+
Amoxicillin
+
Lansoprazole
Total medical expenditures per year (USD, in millions)
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Clarithromycin
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Amoxicillin
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Omeprazole
Total medical expenditures per year (USD, in millions)
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Clarithromycin
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 27,000 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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30,509 adverse events reported
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