NDAINJECTIONINJECTABLE
Approved
Mar 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
4/8 — Partial
INDOMETHACIN (indomethacin) by Fresenius Kabi is cyclooxygenase inhibitors [moa]. First approved in 2010.
Drug data last refreshed 10h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) administered by injection that works by inhibiting cyclooxygenase enzymes to reduce inflammation and pain. It is primarily used for acute inflammatory conditions and has been approved since 2010. The injectable formulation targets patients requiring rapid anti-inflammatory response in hospital or clinical settings.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating consolidation of commercial teams and shift toward cost management and customer retention strategies.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
Started Dec 2024
1,504 enrolled
Acute PancreatitisComplicationMortality Rate+1 more
Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin
Started Sep 2019
26 enrolled
Drug-drug Interaction
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Started Mar 2019
1,734 enrolled
Post ERCP Pancreatitis
A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components
Started Jun 2018
177 enrolled
Contraception
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy
Started Mar 2017
22 enrolled
Stage III Prostate Adenocarcinoma AJCC v7Stage III Prostate Cancer AJCC v7Stage IV Prostate Adenocarcinoma AJCC v7+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.