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Last Updated: June 24, 2021

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PRECEDEX Drug 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 forty-seven patent family members in thirty-four countries.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-three 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

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Recent Clinical Trials for PRECEDEX

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

SponsorPhase
Kingston Health Sciences CentrePhase 1/Phase 2
The Ottawa HospitalPhase 1/Phase 2
Bruyere Research InstitutePhase 1/Phase 2

See all PRECEDEX clinical trials

Pharmacology for PRECEDEX
Paragraph IV (Patent) Challenges for PRECEDEX
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

US Patents and Regulatory Information for PRECEDEX

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 Before You Buy   Try Before You Buy   Try Before You Buy
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>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 Before You Buy   Try Before You Buy
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014   Try Before You Buy   Try Before You Buy
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PRECEDEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1069893 C01069893/01 Switzerland   Try Before You Buy FORMER OWNER: ORION CORPORATION, FI
0300652 C300117 Netherlands   Try Before You Buy PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
0300652 SPC/GB03/005 United Kingdom   Try Before You Buy PRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Express Scripts
Harvard Business School
Johnson and Johnson
Moodys

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