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Profile for Tradename: PRECEDEX

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

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

Summary for Tradename: PRECEDEX

Patents:6
Applicants:1
NDAs:1
Suppliers: see list2

Pharmacology for Tradename: PRECEDEX

Clinical Trials for: PRECEDEX

Glossary
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;INJECTION021038Mar 13, 2013RXYes<disabled><disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes8,648,106*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Dec 17, 1999RXYes4,910,214*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes<disabled><disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes4,910,214*PED<disabled>Y<disabled>
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Paragraph IV activity for: PRECEDEX

Drugname Dosage Strength RLD Submissiondate
dexmedetomidineInjection100 mcg/mLPrecedex4/8/2009
dexmedetomidineInjection4 mcg/mL, 50 mL and 100 mL vialsPrecedex12/26/2013
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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