NDAORALTABLET
Approved
Oct 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
3/8 — Basic
ORUDIS KT (ketoprofen) by Pfizer is cyclooxygenase inhibitors [moa]. First approved in 1995.
Drug data last refreshed 21h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORUDIS KT is an oral nonsteroidal anti-inflammatory drug (NSAID) containing ketoprofen that works by inhibiting cyclooxygenase enzymes to reduce pain and inflammation. It is indicated for acute pain, chronic pain conditions including low back pain and osteoarthritis. The product targets patients seeking over-the-counter or prescription pain relief without opioid exposure.
LOE Approaching
ORUDIS KT operates in a mature, highly competitive market with moderate competitive pressure (30); expect downsizing or transition planning as patent expiration approaches.
Mechanism of Action
Cyclooxygenase Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males
Started Feb 2021
141 enrolled
No Condition
Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain
Started Sep 2020
538 enrolled
Low Back Pain
A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac
Started Mar 2020
236 enrolled
Osteoarthritis
A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo
Started Apr 2018
70 enrolled
Acute Pain
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment
Started Mar 2018
416 enrolled
Musculoskeletal Pain
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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.