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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 five patents protecting this drug and two Paragraph IV challenges.

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

Summary for Tradename: PRECEDEX

Suppliers / Packagers: see list5

Pharmacology for Tradename: PRECEDEX

Clinical Trials for: PRECEDEX

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

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

Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia
Status: Completed Condition: Vitreoretinal Surgery Under Sub-Tenon's Anesthesia

Dexmedetomidine vs Fentanyl for BMT
Status: Completed Condition: Otitis

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

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

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 Sedation With Third Molar Surgery
Status: Terminated Condition: Anesthesia

Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery
Status: Not yet recruiting Condition: Arteriovenous Malformation

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXNo8,338,470*PED<disabled>Y<disabled>
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYes8,242,158*PED<disabled>Y<disabled>
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999RXYes<disabled><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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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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