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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Chubb
Daiichi Sankyo
Moodys
Novartis
Covington
Cerilliant
Farmers Insurance
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Generated: September 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, 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;INJECTION021038-003Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Hq Spclt Pharma
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
SOLUTION;IV (INFUSION)206628-001Oct 21, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Luitpold Pharms Inc
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
INJECTABLE;INJECTION203773-001May 12, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Fresenius Kabi Usa
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
INJECTABLE;INJECTION201072-001Sep 18, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
INJECTABLE;INJECTION205867-001Mar 17, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999APRXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXYesYes► 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
Japan5892177► Subscribe
World Intellectual Property Organization (WIPO)2013103378► Subscribe
Canada2806706► Subscribe
Eurasian Patent Organization200001010► Subscribe
Denmark1069893► Subscribe
Japan2015110639► Subscribe
South Korea101632103► Subscribe
South Africa201301649► Subscribe
Austria347359► Subscribe
Poland192517► 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
03C/005Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Farmers Insurance
QuintilesIMS
US Department of Justice
Merck
Citi
Argus Health
Boehringer Ingelheim
Dow
Federal Trade Commission

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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