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PRECEDEX Drug Profile

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Precedex is a drug marketed by Hospira and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and three Paragraph IV challenges.

This drug has thirty-four patent family members in twenty-seven countries.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

Summary for Tradename: PRECEDEX

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: PRECEDEX

Clinical Trials for: PRECEDEX

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, 2014RXYes8,338,470*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYes8,242,158*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999RXYes<disabled><disabled>
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Expired Patents for Tradename: PRECEDEX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 20134,910,214*PED<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 19995,344,840<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 19994,910,214*PED<disabled>
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Paragraph IV activity 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

International Patent Family for Tradename: PRECEDEX

Country Document Number Estimated Expiration
Portugal1069893<disabled in preview>
World Intellectual Property Organization (WIPO)9949854<disabled in preview>
Japan2002509880<disabled in preview>
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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
03C/005Belgium<disabled>PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
1069893/01Switzerland<disabled>PRODUCT NAME: DEXMEDETOMIDIN; REGISTRATION NO/DATE: SWISSMEDIC 62183 25.10.2012
00117Netherlands<disabled>PRODUCT 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
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