NDAINTRAVENOUSSOLUTION
Approved
Dec 2014
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
5/8 — Partial
DYLOJECT (diclofenac sodium) by Inpharmus is mechanism of action diclofenac sodium extended-release tablets have analgesic, anti-inflammatory, and antipyretic properties. Approved for pain, postoperative pain, osteoarthritis and 4 more indications. First approved in 2014.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DYLOJECT is an intravenous diclofenac sodium solution approved in 2014 for acute pain management across multiple indications including postoperative pain, osteoarthritis, low back pain, and soft tissue injuries. It works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes to reduce prostaglandin synthesis, thereby decreasing pain, inflammation, and fever. The IV route provides rapid onset compared to oral NSAIDs, making it suitable for perioperative and acute care settings.
LOE Approaching11mo to LOE
Product approaching LOE in March 2027 with only 0.9 years of exclusivity remaining; teams should anticipate downsizing or transition to generic support strategies.
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 (7)
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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.