DICLOFENAC POTASSIUM

Post-LOE

diclofenac potassium

Medica Corp

ANDAORALFOR SOLUTION

Approved

Jan 2025

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

DICLOFENAC POTASSIUM (diclofenac potassium) by Medica Corp is analgesic, anti-inflammatory, and antipyretic properties. Approved for migraine. First approved in 2025.

Drug data last refreshed 18h ago

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Mechanism of Action

analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac potassium, 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 in vitro.…

Indications (1)

migraine

Clinical Trials (4)

NCT02476422Phase 3Completed

A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

Started Apr 2015

328 enrolled

Post Operative Dental Pain

NCT01666197Phase 4Completed

Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

Started Aug 2012

100 enrolled

Ankle Sprain

NCT01257126Phase 4Withdrawn

Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection

Started Apr 2011

Upper Respiratory Tract Infections

NCT01019980Phase 4Terminated

Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

Started Mar 2010

2 enrolled

Fever

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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.