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Profile for Tradename: PRECEDEX

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Precedex is a drug marketed by Hospira and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

Summary for Tradename: PRECEDEX

Patents:6
Applicants:1
NDAs:1
Suppliers: see list2

Pharmacology for Tradename: PRECEDEX

Clinical Trials for: PRECEDEX

Dexmedetomidine Sedation With Third Molar Surgery
Status: Terminated Condition: Anesthesia

Safety and Efficacy Study of Dexmedetomidine in Pediatrics Ages >= 28 Weeks to <= 44 Weeks Gestational Age
Status: Completed Condition: Sedation

Dexmedetomidine Pharmacokinetics in the Obese
Status: Completed Condition: Obesity

Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Status: Completed Condition: Unstable Angina; Coronary Artery Bypass Graft; Dexmedetomidine; Lidocaine; Myocardial Injury; Arrhythmia; Blood Electrolyte Balance

The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children
Status: Completed Condition: Hemodynamic Instability

Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
Status: Completed Condition: Cranitomy Surgery

Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Status: Active, not recruiting Condition: Strabismus; Delirium on Emergence; Pediatric Disorders

Dexmedetomidine vs Fentanyl for BMT
Status: Completed Condition: Otitis

Dexmedetomidine in Spinal Anesthesia
Status: Recruiting Condition: Blood Pressure; Anxiety

Comparison of Dexmedetomidine and Remifentanil Infusion During CABG
Status: Completed Condition: Coronary Artery Bypass Graft; Hypokalemia; Cardiac Arrhythmia; Dexmedetomidine; Remifentanil

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes8,648,106*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes4,910,214*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes8,455,527*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Dec 17, 1999RXYes4,910,214*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes8,242,158*PED<disabled>Y<disabled>
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Paragraph IV activity for: PRECEDEX

Drugname Dosage Strength RLD Submissiondate
dexmedetomidineInjection100 mcg/mLPrecedex4/8/2009
dexmedetomidineInjection4 mcg/mL, 50 mL and 100 mL vialsPrecedex12/26/2013
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