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Details for Generic Name: dexmedetomidine hydrochloride

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Dexmedetomidine hydrochloride is the generic ingredient in two branded drugs marketed by Akorn Inc, Fresenius Kabi Usa, Mylan Institutional, Par Sterile Products, Sun Pharm Inds Inc, Hospira, and Hq Spclt Pharma, and is included in seven NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for dexmedetomidine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: dexmedetomidine hydrochloride

Drug Master File Entries: see list12
Suppliers / Packaging: see list5

Pharmacology for Ingredient: dexmedetomidine hydrochloride


Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION100MCG

Clinical Trials for: dexmedetomidine hydrochloride

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

Small Doses of Dexmedetomidine for Emergence Agitation
Status: Recruiting Condition: Emergence Agitation

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

Dexmedetomidine Pharmacokinetics in the Obese
Status: Completed Condition: Obesity

Dexmedetomidine vs Fentanyl for BMT
Status: Completed Condition: Otitis

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

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;INJECTION021038-002Mar 13, 2013RXYes8,242,158*PED<disabled>Y<disabled>
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXNo8,338,470*PED<disabled>Y<disabled>
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYes<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

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

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