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Last Updated: March 19, 2024

PRECEDEX Drug Patent Profile


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When do Precedex patents expire, and what generic alternatives are available?

Precedex is a drug marketed by Hospira and is included in one NDA. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-one patent family members in thirty-five countries.

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

Drug patent expirations by year for PRECEDEX
Drug Prices for PRECEDEX

See drug prices for PRECEDEX

Recent Clinical Trials for PRECEDEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Samsung Medical CenterN/A
Korea Institute of Science and TechnologyN/A
Assiut UniversityN/A

See all PRECEDEX clinical trials

Pharmacology for PRECEDEX
Drug ClassCentral alpha-2 Adrenergic Agonist
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Anatomical Therapeutic Chemical (ATC) Classes for PRECEDEX
Paragraph IV (Patent) Challenges for PRECEDEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRECEDEX Injection dexmedetomidine hydrochloride 4 mcg/mL, 20 mL vials 021038 1 2015-09-30
PRECEDEX Injection dexmedetomidine hydrochloride 4 mcg/mL, 50 mL and 100 mL vials 021038 1 2013-12-26
PRECEDEX Injection dexmedetomidine hydrochloride 100 mcg/mL 021038 1 2009-04-08

US Patents and Regulatory Information for PRECEDEX

PRECEDEX is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting PRECEDEX

Dexmedetomidine premix formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dexmedetomidine premix formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dexmedetomidine premix formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting PRECEDEX

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-005 Jan 31, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PRECEDEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PRECEDEX

See the table below for patents covering PRECEDEX around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1069893 UTILISATION DE DEXMEDETOMIDINE POUR LA SEDATION DANS UNE UNITE DE SOINS INTENSIFS (USE OF DEXMEDETOMIDINE FOR ICU SEDATION) ⤷  Try a Trial
Portugal 1069893 ⤷  Try a Trial
United Kingdom 2352972 Use of dexmedetomidine for icu sedation ⤷  Try a Trial
Argentina 089673 FORMULACION DE PREMEZCLA DE DEXMEDETOMIDINA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRECEDEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0300652 300117 Netherlands ⤷  Try a Trial 300117, 20080708, EXPIRES: 20130707
0300652 91010 Luxembourg ⤷  Try a Trial
0300652 2003C/005 Belgium ⤷  Try a Trial PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
1069893 C01069893/01 Switzerland ⤷  Try a Trial FORMER OWNER: ORION CORPORATION, FI
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.