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Generated: September 21, 2017

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 twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

Summary for NDA: 021038

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:7
Formulation / Manufacturing:see details

Pharmacology for NDA: 021038

Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia

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 0409-1660-10 10 BOTTLE in 1 TRAY (0409-1660-10) > 100 mL in 1 BOTTLE

Summary 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

Summary 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 Orange Book Patents for NDA: 021038

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;INJECTION021038-002Mar 13, 2013► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Cerilliant
UBS
Teva
Boehringer Ingelheim
Julphar
Moodys
Medtronic
Harvard Business School
Fish and Richardson
Farmers Insurance

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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