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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 three 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

Tradenames:2
Patents:5
Applicants:7
NDAs:7
Drug Master File Entries: see list12
Suppliers / Packaging: see list5

Pharmacology for Ingredient: dexmedetomidine hydrochloride

Tentative approvals for DEXMEDETOMIDINE HYDROCHLORIDE

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

Clinical Trials for: dexmedetomidine hydrochloride

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;INJECTION021038-004Nov 14, 2014RXNo8,648,106*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013RXYes8,242,158*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013RXYes8,648,106*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: dexmedetomidine hydrochloride

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 19994,910,214*PED<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 20134,910,214*PED<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 20134,910,214*PED<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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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