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: December 9, 2019

DrugPatentWatch Database Preview

DEXMEDETOMIDINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for dexmedetomidine hydrochloride and what is the scope of patent protection?

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 ninety-one patent family members in forty-one countries.

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

Recent Clinical Trials for DEXMEDETOMIDINE HYDROCHLORIDE

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

SponsorPhase
Douglas FraserPhase 3
Maria TileliPhase 2
Asklepieion Voulas General HospitalPhase 2

See all DEXMEDETOMIDINE HYDROCHLORIDE clinical trials

Recent Litigation for DEXMEDETOMIDINE HYDROCHLORIDE

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 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

Generic filers with tentative approvals for DEXMEDETOMIDINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Paragraph IV (Patent) Challenges for DEXMEDETOMIDINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 2013-12-26
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 2009-04-08

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
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-001 Oct 21, 2015 RX Yes No   Start Trial   Start Trial   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 021038-002 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
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 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 DEXMEDETOMIDINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013   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 021038-001 Dec 17, 1999   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 021038-001 Dec 17, 1999   Start Trial   Start Trial
>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   Start Trial PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
1069893 C01069893/01 Switzerland   Start Trial FORMER OWNER: ORION CORPORATION, FI
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Mallinckrodt
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