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Serving leading biopharmaceutical companies globally:

Chubb
US Army
Julphar
McKinsey
Cantor Fitzgerald
Cerilliant
Fuji
UBS
Daiichi Sankyo
QuintilesIMS

Generated: November 21, 2017

DrugPatentWatch Database Preview

PRECEDEX Drug Profile

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Which patents cover Precedex, and when can generic versions of Precedex launch?

Precedex is a drug marketed by Hospira and is included in one NDA. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-one patent family members in thirty-seven countries and three supplementary protection certificates in three countries.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
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;INJECTION021038-003Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-004Nov 14, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
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;INJECTION021038-003Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999APRXYesYes► Subscribe► SubscribeY► Subscribe
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;INJECTION021038-002Mar 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: PRECEDEX

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;INJECTION021038-003Mar 13, 2013► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for PRECEDEX

Drugname Dosage Strength RLD Submissiondate
dexmedetomidine Injection 4 mcg/mL, 20 mL vials Precedex 9/30/2015
dexmedetomidineInjection100 mcg/mLPrecedex4/8/2009
dexmedetomidineInjection4 mcg/mL, 50 mL and 100 mL vialsPrecedex12/26/2013

Non-Orange Book Patents for Tradename: PRECEDEX

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 Tradename: PRECEDEX

Country Document Number Estimated Expiration
Spain2278441► Subscribe
China1168441► Subscribe
Japan2014508746► Subscribe
European Patent Office2648520► Subscribe
Japan2015110639► Subscribe
Mexico2013003629► Subscribe
Argentina015744► Subscribe
Malaysia161022► Subscribe
Norway329194► Subscribe
Brazil112013008005► 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: PRECEDEX

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 leading biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
Chubb
Cerilliant
Citi
Express Scripts
Covington
Daiichi Sankyo
Novartis
Moodys

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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