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AboutPricing
Drug ReportsIndomethacin
Indomethacin
Indocin, Indomethacin (indomethacin) is a small molecule pharmaceutical. Indomethacin was first approved as Indocin on 1982-01-01. It is used to treat ankylosing spondylitis, bursitis, gouty arthritis, inflammation, and osteoarthritis amongst others in the USA. It is known to target prostaglandin G/H synthase 2, prostaglandin D2 receptor 2, proton-coupled folate transporter, prostaglandin G/H synthase 1, and peroxisome proliferator-activated receptor gamma.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Indocin, Indomethacin (discontinued: Indo-lemmon, Indocin, Indomethacin, Tivorbex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indomethacin
Tradename
Company
Number
Date
Products
INDOMETHACINChartwell PharmaceuticalsN-018829 RX1984-08-06
2 products
INDOMETHACINFresenius KabiN-022536 RX2010-03-17
1 products, RLD, RS
INDOCINZyla Life SciencesN-018332 RX1985-10-10
1 products, RLD, RS
Show 9 discontinued
Indomethacin sodium
Tradename
Company
Number
Date
Products
INDOCINRecordatiN-018878 DISCN1985-01-30
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
indocinNew Drug Application2024-12-16
indocin srANDA2010-01-12
indomethacinANDA2025-09-26
indomethacin erANDA2010-04-16
indomethacin extended-releaseANDA2017-12-20
tivorbexNew Drug Application2018-01-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
painEFO_0003843D010146R52
inflammationMP_0001845D007249—
osteoarthritisEFO_0002506D010003M15-M19
bursitisEFO_1000941D002062M71.9
patent ductus arteriosus—D004374Q25.0
gouty arthritis—D015210—
tendinopathyEFO_1001434D052256M77.9
Agency Specific
FDA
EMA
Expiration
Code
INDOMETHACIN, INDOMETHACIN, ZYDUS
2024-01-30CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Indomethacin, Tivorbex, Genus
87348472030-04-23DP
89929822030-04-23DP
90894712030-04-23U-55
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01E: Other cardiac preparations in atc
— C01EB: Other plain cardiac preparations in atc
— C01EB03: Indometacin
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AB: Acetic acid derivatives and related substances
— M01AB01: Indometacin
— M01AB51: Indometacin, combinations
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA23: Indometacin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BC: Antiinflammatory agents, non-steroidal, ophthalmologic
— S01BC01: Indometacin
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CC: Antiinflammatory agents, non-steroids and antiinfectives in combination
— S01CC02: Indometacin and antiinfectives
HCPCS
No data
Clinical
Clinical Trials
577 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0——1——1
Squamous cell carcinoma of head and neckD000077195————1——1
Squamous cell carcinomaD002294————1——1
Indications Phases 2
No data
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 nameIndomethacin
INNindometacin
Description
Indometacin is a member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis. It has a role as an EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor, an analgesic, a gout suppressant, a drug metabolite, a xenobiotic metabolite, a xenobiotic, an environmental contaminant and a non-steroidal anti-inflammatory drug. It is a N-acylindole, a member of monochlorobenzenes, an aromatic ether and a member of indole-3-acetic acids.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Identifiers
PDB—
CAS-ID53-86-1
RxCUI—
ChEMBL IDCHEMBL6
ChEBI ID49662
PubChem CID3715
DrugBankDB00328
UNII IDXXE1CET956 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
AKR1C3
AKR1C3
Organism
Homo sapiens
Gene name
AKR1C3
Gene synonyms
DDH1, HSD17B5, KIAA0119, PGFS
NCBI Gene ID
8644
Protein name
aldo-keto reductase family 1 member C3
Protein synonyms
17-beta-HSD 5, 17-beta-hydroxysteroid dehydrogenase type 5, 3-alpha hydroxysteroid dehydrogenase, type II, 3-alpha-HSD type 2, 3-alpha-HSD type II, brain, 3-alpha-hydroxysteroid dehydrogenase type 2, Chlordecone reductase homolog HAKRb, DD-3, DD3, Dihydrodiol dehydrogenase 3, Dihydrodiol dehydrogenase type I, dihydrodiol dehydrogenase X, HA1753, indanol dehydrogenase, PGFS, Prostaglandin F synthase, Testosterone 17-beta-dehydrogenase 5, trans-1,2-dihydrobenzene-1,2-diol dehydrogenase, type IIb 3-alpha hydroxysteroid dehydrogenase
Uniprot ID
P42330
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Indocin – Assertio Therapeutics
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Indocin – Zyla Life Sciences
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Estimated US medical usage
Indomethacin
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 54,506 documents
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Safety
Black-box Warning
Black-box warning for: Indocin, Indocin sr, Indomethacin, Indomethacin er, Indomethacin extended-release, Tivorbex
Adverse Events
Top Adverse Reactions
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7,710 adverse events reported
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