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Generated: May 25, 2017

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Dexmedetomidine hydrochloride - Generic Drug Details

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What are the generic sources for dexmedetomidine hydrochloride and what is the scope of dexmedetomidine hydrochloride freedom to operate?

Dexmedetomidine hydrochloride
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Sun Pharm Inds Inc, Hq Spclt Pharma, Hospira, West-ward Pharms Int, Sandoz Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Par Sterile Products, Mylan Institutional, Akorn Inc, and Actavis Inc, and is included in twelve NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmedetomidine hydrochloride has sixty-four patent family members in thirty-six countries.

There are twelve drug master file entries for dexmedetomidine hydrochloride. Eleven suppliers are listed for this compound.

Summary for Generic Name: dexmedetomidine hydrochloride

Drug Master File Entries: see list12
Suppliers / Packagers: see list11
Bulk Api Vendors: see list43
Clinical Trials: see list1,259
Patent Applications: see list146
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dexmedetomidine hydrochloride at DailyMed

Pharmacology for Ingredient: dexmedetomidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013RXYesYes9,616,049► SubscribeY ► Subscribe
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXYesYes9,616,049► SubscribeY ► Subscribe
Aurobindo Pharma Ltd
dexmedetomidine hydrochloride
INJECTABLE;INJECTION205867-001Mar 17, 2016APRXNoNo► Subscribe► Subscribe
Sandoz Inc
dexmedetomidine hydrochloride
INJECTABLE;INJECTION091465-001Jun 14, 2016APRXNoNo► Subscribe► Subscribe
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013RXYesYes8,242,158*PED► SubscribeY► Subscribe
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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