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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 14, 2019

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Dexmedetomidine hydrochloride - Generic Drug Details

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What are the generic sources for dexmedetomidine hydrochloride and what is the scope of freedom to operate?

Dexmedetomidine hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis Inc, Akorn Inc, Am Regent, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Cipla, Fresenius Kabi Usa, Jiangsu Hengrui Med, Mylan Institutional, Par Sterile Products, Sandoz Inc, Sun Pharm Inds Inc, Teva Pharms Usa, West-ward Pharms Int, Zydus Pharms, Hospira, and Hq Spclt Pharma, and is included in nineteen NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmedetomidine hydrochloride has eighty-nine patent family members in forty-one countries.

There are fourteen drug master file entries for dexmedetomidine hydrochloride. Twenty suppliers are listed for this compound.

Recent Clinical Trials for dexmedetomidine hydrochloride

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SponsorPhase
Douglas FraserPhase 3
Keith M. Vogt, MD, PhDPhase 4
Yale UniversityPhase 2

See all dexmedetomidine hydrochloride clinical trials

Recent Litigation for dexmedetomidine hydrochloride

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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 dexmedetomidine hydrochloride litigation

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

See all dexmedetomidine hydrochloride litigation

Pharmacology for dexmedetomidine hydrochloride
Medical Subject Heading (MeSH) Categories for dexmedetomidine hydrochloride
Synonyms for dexmedetomidine hydrochloride
(+)-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
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)-a,2,3-trimethylbenzyl)imidazole hydrochloride
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
5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride
A808325
AC-310
AC1OCF03
ACT04745
AK161937
AKOS024457275
AKOS025402024
AM20080946
AS-12485
BC220548
BCP0726000002
BCP9000600
CHEBI:31472
CHEMBL2106195
CS-2451
CTK8E7443
d-Medetomidine hydrochloride
D01205
D5062
Dexdor
Dexmedetomidine (hydrochloride)
Dexmedetomidine HCL
Dexmedetomidine HCl (Precedex)
Dexmedetomidine hydrochloride (JAN/USAN)
Dexmedetomidine hydrochloride [USAN]
dexmedetomidineHCL
FC1262
FT-0082434
FT-0645167
H08D583
HY-17034A
KB-185493
KS-00000KC8
MCULE-2124077600
MLS006011569
MolPort-003-986-435
MolPort-019-991-996
MPV-1440
Precedex
Precedex (TN)
Primadex
Q-100166
RT-012295
s2090
SB17477
SCHEMBL406837
SMR004703327
ST24036207
SW219607-2
TL8000998
UNII-1018WH7F9I
UNII-BH210P244U component VPNGEIHDPSLNMU-MERQFXBCSA-N
VPNGEIHDPSLNMU-MERQFXBCSA-N
Z1617901127

US Patents and Regulatory Information for dexmedetomidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 208129-001 Nov 29, 2018 AP RX No No   See Pricing   See Pricing   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 021038-002 Mar 13, 2013 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sun Pharm Inds Inc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202126-001 Aug 20, 2015 AP RX No No   See Pricing   See Pricing   See Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Mylan Institutional DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202881-001 Aug 18, 2014 AP RX No No   See Pricing   See Pricing   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 dexmedetomidine hydrochloride

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

Supplementary Protection Certificates for dexmedetomidine hydrochloride

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

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