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Last Updated: July 6, 2020

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 two suppliers. 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 fourteen drug master file entries for this compound. Twenty-one 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 (0409-1638-32)
PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038 NDA Hospira, Inc. 0409-1660 0409-1660-10 10 BOTTLE in 1 TRAY (0409-1660-10) > 100 mL in 1 BOTTLE (0409-1660-35)
Paragraph IV (Patent) Challenges for 021038
Tradename Dosage Ingredient NDA Submissiondate
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 2015-09-30
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 2013-12-26
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 2009-04-08

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date:Mar 13, 2013TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 4, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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 021038-004 Nov 14, 2014   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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