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Last Updated: June 2, 2020

DrugPatentWatch Database Preview

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-six patent family members in thirty-three countries.

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

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SponsorPhase
Douglas FraserPhase 3
BioXcel Therapeutics IncPhase 2
Jeff C. Huffman, MDPhase 2

See all PRECEDEX clinical trials

Recent Litigation for PRECEDEX

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District Court Litigation
Case NameDate
Hospira, Inc. v. Jiangsu Hengrui Medicine Co., Ltd.2018-02-01
Hospira, Inc. v. Fresenius Kabi USA, LLC2017-11-01
Hospira Inc. v. Par Sterile Products LLC2016-09-29

See all PRECEDEX litigation

PTAB Litigation
PetitionerDate
Fresenius Kabi USA, LLC2017-03-08
Amneal Pharmaceuticals LLC2016-08-11
Amneal Pharmaceuticals LLC2016-08-10

See all PRECEDEX litigation

Pharmacology for PRECEDEX
Synonyms for PRECEDEX
(+)-Medetomidine hydrochloride
(+)-Medetomidine hydrochloride;(S)-Medetomidine hydrochloride
(S)-4-(1-(2,3-Dimethylphenyl)ethyl)-1H-imidazole hydrochloride
(S)-4-(1-(2,3-Dimethylphenyl)ethyl)-1H-imidazole hydrochloride;Dexmedetomidine hydrochloride
(S)-4-(alpha,2,3-Trimethybenzyl)-1H-imidazole Hydrochloride
(S)-4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole Hydrochloride
(S)-5-(1-(2,3-Dimethylphenyl)ethyl)-1H-imidazole hydrochloride
(S)-Medetomidine hydrochloride
1018WH7F9I
145108-58-3
1H-Imidazole, 4-(1-(2,3-dimethylphenyl)ethyl)-, monohydrochloride, (S)-
1H-Imidazole, 4-[(1S)-1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride
1H-Imidazole, 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-, hydrochloride (1:1)
4-((S)-alpha,2,3-trimethylbenzyl)imidazole monohydrochloride
4-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
4-[(1S)-1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole hydrochloride (1:1)
4-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole;hydrochloride
5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
A11846
A808325
AC-310
ACT04745
AKOS024457275
AKOS025402024
AM20080946
AS-12485
BCP0726000002
BCP9000600
CHEBI:31472
CHEMBL2106195
CS-2451
CTK8E7443
d-Medetomidine hydrochloride
D01205
D5062
Dexdor
Dexmedetomidine (hydrochloride)
Dexmedetomidine HCL
Dexmedetomidine HCl (Precedex)
Dexmedetomidine hydrochloride
Dexmedetomidine hydrochloride (JAN/USAN)
Dexmedetomidine hydrochloride [USAN]
dexmedetomidine-hcl-precedex
dexmedetomidineHCL
DTXSID40873215
FT-0082434
FT-0645167
H08D583
HY-17034A
KS-00000KC8
MCULE-2124077600
MLS006011569
MPV-1440
Precedex (TN)
Primadex
Q-100166
Q27114321
RT-012295
s2090
SB17477
SCHEMBL406837
SMR004703327
ST24036207
SW219607-2
UNII-1018WH7F9I
UNII-BH210P244U component VPNGEIHDPSLNMU-MERQFXBCSA-N
VPNGEIHDPSLNMU-MERQFXBCSA-N
Z1617901127
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 021038-004 Nov 14, 2014 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes   Start Trial   Start Trial Y   Start 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   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 021038-004 Nov 14, 2014   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 021038-003 Mar 13, 2013   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013   Start Trial   Start Trial
>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
0300652 C300117 Netherlands   Start Trial 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
1069893 C01069893/01 Switzerland   Start Trial FORMER OWNER: ORION CORPORATION, FI
0300652 91010 Luxembourg   Start Trial
0300652 7/2003 Austria   Start Trial PRODUCT NAME: DEXMEDETOMIDIN HYDROCHLORID; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
0300652 SPC/GB03/005 United Kingdom   Start Trial 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
0300652 2003C/005 Belgium   Start Trial PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
>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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