CALDOLOR

PeakSM

ibuprofen

NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Jun 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Cyclooxygenase Inhibitors

Pharmacologic Class:

Nonsteroidal Anti-inflammatory Drug

Clinical Trials (5)

NCT04630834Phase 4Unknown

Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction

Started Mar 2021
NCT03722238Phase 3Terminated

Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers

Started Dec 2018
613 enrolled
Pain
NCT03385057Phase 1Withdrawn

Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy

Started Sep 2018
0
Tonsillectomy With or Without Adenoidectomy
NCT03789058Phase 2/3Unknown

Efficacy of Ibuprofen Chronotherapy in Healing After Surgical Extraction of the Mandibular Third Molar

Started Apr 2018
NCT03404206Phase 4Completed

A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

Started Feb 2018
387 enrolled
Pain, Postoperative

Loss of Exclusivity

LOE Date
Mar 16, 2032
73 months away
Patent Expiry
Mar 16, 2032
Exclusivity Expiry
May 11, 2026

Patent Records (5)

Patent #ExpiryTypeUse Code
9114068
Sep 30, 2029
U-1735
9295639
Sep 30, 2029
U-1756
9649284
Sep 30, 2029
U-2018
9138404
Sep 30, 2029
U-1756
8735452
Sep 30, 2029
U-981