ZORVOLEX
Peakdiclofenac
NDAORALCAPSULE
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
ZORVOLEX (diclofenac) is analgesic, anti-inflammatory, and antipyretic properties. First approved in 2013.
Drug data last refreshed 10h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZORVOLEX is an oral capsule formulation of diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) approved in 2013. It works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes to reduce prostaglandin synthesis, delivering analgesic, anti-inflammatory, and antipyretic effects. ZORVOLEX is indicated for pain management in patients requiring NSAID therapy.
$0.006BPart D
LOE Approaching3.5 years to LOEZORVOLEX is approaching loss of exclusivity with modest Part D spending, indicating a mature asset with limited growth potential and a likely contracting sales team.
Mechanism of Action
analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium topical solution, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX- 2). Diclofenac is a potent inhibitor of prostaglandin synthesis…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy of Diclofenac Sodium Shock Wave Phonophoresis on Patients With Subacromial Impingement Syndrome
Started Jun 2026
70 enrolled
Shock WaveSubacromial Impingement Syndrome
A Study of Diclofenac Gel in Women With Primary Dysmenorrhea
Started May 2023
42 enrolled
Dysmenorrhea Primary
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
A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.
Started Aug 2021
76 enrolled
Soft Tissue Injury
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
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.