NDAINTRAVENOUSSOLUTION
Approved
Dec 2014
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
4/8 — Partial
DYLOJECT (diclofenac sodium) by Inpharmus is mechanism of action diclofenac sodium extended-release tablets have analgesic, anti-inflammatory, and antipyretic properties. First approved in 2014.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DYLOJECT is an intravenous formulation of diclofenac sodium, a potent nonsteroidal anti-inflammatory drug (NSAID) that provides analgesic, anti-inflammatory, and antipyretic effects. It works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes to reduce prostaglandin synthesis, thereby decreasing pain and inflammation. The IV route enables rapid onset for acute pain management in perioperative and other acute care settings.
LOE Approaching9mo to LOE
Product is approaching loss of exclusivity with minimal linked job openings, indicating a consolidating brand team focused on transition planning rather than growth investment.
Mechanism of Action
Mechanism of Action Diclofenac sodium extended-release tablets have analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium extended-release tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
Started Oct 2022
447 enrolled
Keratosis, Actinic
To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.
Started Jan 2021
110 enrolled
Postural Low Back PainMechanical Low Back Pain
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
Started Oct 2015
492 enrolled
Actinic Keratosis
Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
Started Apr 2015
502 enrolled
Actinic Keratosis (AK)
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Started Dec 2014
215 enrolled
Acute Blunt Soft Tissue Injuries/Contusions
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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.