VOLTAREN
LOE ApproachingNDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Mar 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VOLTAREN is a topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) administered as eye drops for post-operative inflammation and pain management. The product is a small-molecule NSAID that inhibits prostaglandin synthesis in ocular tissues. It has been a mainstay of post-surgical eye care since its approval in 1991.
LOE Approaching
With LOE approaching and moderate competitive pressure (30/100), the brand team faces declining market share and likely resource reallocation toward newer ophthalmic products.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
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
Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study
Started Oct 2019
313 enrolled
Pain
Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery
Started Oct 2018
Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Started Oct 2014
18 enrolled
Pain
An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS
Started Mar 2014
24 enrolled
PainDelayed Onset Muscle Soreness
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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.