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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Chinese Patent Office
Daiichi Sankyo
Argus Health
McKesson
Cantor Fitzgerald
Farmers Insurance
Express Scripts
Baxter
Medtronic

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021038

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NDA 021038 describes PRECEDEX, which is a drug marketed by Hospira and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the PRECEDEX profile page.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 021038
Tradename:PRECEDEX
Applicant:Hospira
Ingredient:dexmedetomidine hydrochloride
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 021038
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 021038
Suppliers and Packaging for NDA: 021038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038 NDA Hospira, Inc. 0409-1638 0409-1638-02 25 VIAL in 1 TRAY (0409-1638-02) > 2 mL in 1 VIAL
PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038 NDA Hospira, Inc. 0409-1660 0409-1660-50 20 BOTTLE in 1 TRAY (0409-1660-50) > 50 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Dec 17, 1999TE:APRLD:Yes
Patent:➤ SubscribePatent Expiration:Oct 1, 2019Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date:Mar 13, 2013TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Oct 1, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ SubscribePatent Expiration:Jul 4, 2032Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021038

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
McKinsey
QuintilesIMS
Accenture
Argus Health
Cantor Fitzgerald
McKesson
Queensland Health

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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