Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Moodys
Dow
McKesson
Baxter

Last Updated: October 15, 2019

DrugPatentWatch Database Preview

PRECEDEX Drug Profile

See Plans and Pricing

« Back to Dashboard

Which patents cover Precedex, and when can generic versions of Precedex launch?

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

This drug has eighty-five patent family members in forty-one countries.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty 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
Douglas FraserPhase 3
Keith M. Vogt, MD, PhDPhase 4
Yale UniversityPhase 2

See all PRECEDEX clinical trials

Recent Litigation for PRECEDEX

Identify potential future generic entrants

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
( inverted exclamation markA)-4-(a,2,3-trimethylbenzyl)imidazole monohydrochloride
(+-)-4-(alpha,2,3-Trimethylbenzyl)imidazole monohydrochloride
(+)-Medetomidine hydrochloride
(+)-Medetomidine hydrochloride;(S)-Medetomidine hydrochloride
(+/-)-5-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
(R)-4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole hydrochloride
(R)-4-[1-(2,3-Dimethylphenyl)ethyl]-1Himidazole 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
0ME8LX4A7B
1018WH7F9I
106807-72-1
145108-58-3
190000-46-5
1H-Imidazole, 4-(1-(2,3-dimethylphenyl)ethyl)-, monohydrochloride, (+-)-
1H-Imidazole, 4-(1-(2,3-dimethylphenyl)ethyl)-, monohydrochloride, (S)-
1H-Imidazole, 4-[(1S)-1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride
1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride
1H-Imidazole, 5-((1R)-1-(2,3-dimethylphenyl)ethyl)-, hydrochloride (1:1)
1H-Imidazole, 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-, hydrochloride (1:1)
347M151
4-((S)-|A,2,3-Trimethylbenzyl)imidazole monohydrochloride; 4-[(1R)-1-(2,3-Dimethylphenyl)ethyl]-3Himidazole hydrochloride
4-((s)-a,2,3-trimethylbenzyl)imidazole hydrochloride
4-((S)-alpha,2,3-trimethylbenzyl)imidazole monohydrochloride
4-(1-(2,3-Dimethylphenyl)ethyl)-1H-imidazole hydrochloride
4-[(1R)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
4-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
4-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole;hydrochloride
4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole MonoHydrochloride
5-(1-(2,3-dimethylphenyl)ethyl)-1H-imidazole hydrochloride
5-[(1R)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole;hydrochloride
5-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
5-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole;hydrochloride
86347-14-0 (Parent)
86347-15-1
A808325
AB1007069
AB1007070
AC-310
AC-932
AC1L2A2V
AC1L3WYD
AC1OCF03
AC1Q3CME
ACT04744
ACT04745
AK-56227
AK161937
AKOS015889321
AKOS015889402
AKOS015950971
AKOS024457275
AKOS024458523
AKOS025402024
AM20041260
AM20080946
AN-15431
AN-15973
AS-12485
AS-2748
B1361
BC220548
BC226725
BCP04768
BCP04773
BCP0726000002
BCP0726000011
BCP9000600
BCP9000903
C-14040
C13H16N2.HCl
CAS-86347-15-1
CHEBI:31472
CHEBI:48556
CHEBI:48557
CHEMBL2106195
CHEMBL537161
CS-2451
CS-2700
CTK8C9523
CTK8E7443
CTK8E7444
CTK8G9795
d-Medetomidine hydrochloride
D01205
D04883
D5062
Dexdor
Dexmedetomidine (hydrochloride)
Dexmedetomidine HCL
Dexmedetomidine HCl (Precedex)
Dexmedetomidine hydrochloride
Dexmedetomidine hydrochloride (JAN/USAN)
Dexmedetomidine hydrochloride [USAN]
dexmedetomidineHCL
Domitor
Domitor hydrochloride
DSSTox_CID_25691
DSSTox_GSID_45691
DSSTox_RID_81063
DTXSID3045691
FC1261
FC1262
FT-0082434
FT-0630939
FT-0645167
H08D583
HY-17034A
HY-17034B
I01-1858
I01-1867
KB-185493
KB-207998
KS-00000KC8
KS-00000KS1
Levomedetomidine [USP-RS]
levomedetomidine hydrochloride
LS-173234
M-1755
MCULE-2124077600
medetomidin hydrochloride
Medetomidine (hydrochloride)
Medetomidine HCl
Medetomidine hydrochloride
Medetomidine hydrochloride (USAN)
Medetomidine hydrochloride [USAN]
Medetomidine hydrochloride, (-)-
Medetomidine hydrochloride, (R)-
Metomidine
MLS003882579
MLS006011569
MolPort-003-983-621
MolPort-003-986-435
MolPort-005-943-531
MolPort-019-991-996
MPV 785
MPV-1440
MPV-785
MPV785
NCGC00025347-01
Precedex (TN)
Primadex
Q-100166
Q-100867
RT-012295
RT-013677
s2090
s3060
SB17477
SC-24532
SCHEMBL204843
SCHEMBL406837
SMR002533644
SMR004703327
SR-01000597778
SR-01000597778-1
ST24036207
ST24042785
SW219239-1
SW219607-2
TL8000998
Tox21_110966
UNII-0ME8LX4A7B
UNII-1018WH7F9I
UNII-BH210P244U component VPNGEIHDPSLNMU-MERQFXBCSA-N
UNII-BH210P244U component VPNGEIHDPSLNMU-RFVHGSKJSA-N
VPNGEIHDPSLNMU-MERQFXBCSA-N
VPNGEIHDPSLNMU-UHFFFAOYSA-N
Z1617901127
Zalopine

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   See Pricing   See Pricing Y   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>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 021038-003 Mar 13, 2013   See Pricing   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014   See Pricing   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999   See Pricing   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013   See Pricing   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999   See Pricing   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013   See Pricing   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PRECEDEX
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 4 mcg/mL, 20 mL vials ➤ Subscribe   See Pricing
➤ Subscribe Injection 100 mcg/mL ➤ Subscribe   See Pricing
➤ Subscribe Injection 4 mcg/mL, 50 mL and 100 mL vials ➤ Subscribe   See Pricing

Supplementary Protection Certificates for PRECEDEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1069893 C01069893/01 Switzerland   See Pricing FORMER OWNER: ORION CORPORATION, FI
0300652 2003C/005 Belgium   See Pricing PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
0300652 C300117 Netherlands   See Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Boehringer Ingelheim
Baxter
Johnson and Johnson
Medtronic

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.