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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Fish and Richardson
Dow
Citi
Moodys
Cerilliant
Covington
UBS
McKinsey
QuintilesIMS

Generated: September 26, 2017

DrugPatentWatch Database Preview

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, Luitpold Pharms Inc, Mylan Institutional, Akorn Inc, and Actavis Inc, and is included in thirteen NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: dexmedetomidine hydrochloride

Tradenames:2
Patents:7
Applicants:13
NDAs:13
Drug Master File Entries: see list12
Suppliers / Packagers: see list12
Bulk Api Vendors: see list43
Clinical Trials: see list2,832
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
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999APRXYesYes► Subscribe► SubscribeY► Subscribe
Aurobindo Pharma Ltd
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
INJECTABLE;INJECTION205867-001Mar 17, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Akorn Inc
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
INJECTABLE;INJECTION202585-001Nov 24, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Accord Hlthcare
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
INJECTABLE;INJECTION204023-001Feb 9, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dexmedetomidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dexmedetomidine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,436,033Methods of treatment using a dexmedetomidine premix formulation► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: dexmedetomidine hydrochloride

Country Document Number Estimated Expiration
New Zealand507203► Subscribe
Slovakia286160► Subscribe
Argentina089673► Subscribe
Canada2806706► Subscribe
Peru06812016► Subscribe
TaiwanI574688► Subscribe
United Kingdom2352972► Subscribe
Turkey200002837► Subscribe
Israel138416► Subscribe
Czech Republic20003484► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DEXMEDETOMIDINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00117Netherlands► SubscribePRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
1069893/01Switzerland► SubscribeFORMER OWNER: ORION CORPORATION, FI
03C/005Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Dow
Cantor Fitzgerald
Cerilliant
McKinsey
AstraZeneca
Harvard Business School
Healthtrust
Accenture
Merck

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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