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Drug ReportsDoxycycline
Doxycycline anhydrous
Doxycycline, Monodox, Oracea, Vibramycin (doxycycline anhydrous) is a small molecule pharmaceutical. Doxycycline anhydrous was first approved as Vibramycin on 1982-01-01. It is used to treat anthrax, bacterial pneumonia, campylobacter infections, cholera, and granuloma inguinale amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
eye diseasesD005128
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Doxycycline, Monodox, Oracea (discontinued: Doxycycline, Vibramycin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxycycline
Tradename
Company
Number
Date
Products
MONODOXChartwell PharmaceuticalsN-050641 RX1989-12-29
4 products, RLD
ORACEAGaldermaN-050805 RX2006-05-26
1 products, RLD, RS
Show 1 discontinued
Doxycycline calcium
Tradename
Company
Number
Date
Products
VIBRAMYCINPfizerN-050480 DISCN1982-01-01
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
acticlateNew Drug Application2017-11-28
benoxyldoxy 30 kitunapproved drug other2015-10-19
benzodox 30 kitunapproved drug other2015-10-20
benzodox 60 kitunapproved drug other2015-10-16
direct rxANDA2015-08-04
doryxNew Drug Application2023-05-30
doryx mpcNew Drug Application2024-04-26
doxy 100ANDA2021-02-17
doxy 100(tm) doxycyclineANDA2024-01-30
doxycyclate hyclateANDA2024-08-12
Show 13 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Doxycycline, Oracea, Galderma Labs Lp
77495322027-12-19DPU-1063
82067402025-12-24DPU-925
83944052024-04-07DPU-925
83944062024-04-07DPU-925
84703642024-04-07DPU-925
87094782024-04-07U-1063
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB22: Doxycycline
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01A: Tetracycline antibiotics
— J01AA: Tetracyclines
— J01AA02: Doxycycline
HCPCS
No data
Clinical
Clinical Trials
434 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial infectionsD001424—A49———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Persian gulf syndromeD018923EFO_0007430———1——1
Mycoplasma infectionsD009175————1——1
PleuropneumoniaD011001————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289———1———1
Lung neoplasmsD008175HP_0100526C34.90—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDoxycycline anhydrous
INNdoxycycline
Description
Doxycycline is tetracycline in which the 5beta-hydrogen is replaced by a hydroxy group, while the 6alpha-hydroxy group is replaced by hydrogen. A semi-synthetic tetracycline antibiotic, it is used to inhibit bacterial protein synthesis and treat non-gonococcal urethritis and cervicitis, exacerbations of bronchitis in patients with chronic obstructive pulmonary disease (COPD), and adult periodontitis. It has a role as an antibacterial drug, an antimalarial, a geroprotector, an anti-inflammatory agent and an immunomodulator.
Classification
Small molecule
Drug classantibiotics (tetracycline derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@H]1c2cccc(O)c2C(=O)C2=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@@H]3[C@@H](O)[C@@H]21
Identifiers
PDB—
CAS-ID564-25-0
RxCUI—
ChEMBL IDCHEMBL1433
ChEBI ID50845
PubChem CID—
DrugBankDB00254
UNII ID334895S862 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Doxycycline – Fortress Biotech
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Doxycycline – Journey Medical
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Estimated US medical usage
Doxycycline anhydrous
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Doxycycline
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 86,186 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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24,791 adverse events reported
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