NDAORALCAPSULE
Approved
Jun 2009
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
4
Data completeness
5/8 — Partial
ZIPSOR (diclofenac potassium) by Medica Corp is analgesic, anti-inflammatory, and antipyretic properties. First approved in 2009.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZIPSOR is an oral immediate-release capsule formulation of diclofenac potassium, a nonsteroidal anti-inflammatory drug (NSAID) approved in 2009. It provides analgesic, anti-inflammatory, and antipyretic effects by inhibiting COX-1 and COX-2 enzymes and reducing prostaglandin synthesis in peripheral tissues. The drug is indicated for acute pain management where rapid onset of action is desired.
$0.797MPart D
LOE Approaching2.7 years to LOEWith LOE approaching in 2.7 years and minimal Part D spending, the brand team is likely in defensive consolidation mode with reduced headcount and focus on key accounts.
Mechanism of Action
analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of ZIPSOR, 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. Diclofenac…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
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
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
Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
Started Apr 2011
0Upper Respiratory Tract Infections
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.