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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cerilliant
UBS
Healthtrust
Federal Trade Commission
Julphar
Fish and Richardson
Medtronic
Covington

Generated: April 26, 2018

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 dexmedetomidine hydrochloride freedom to operate?

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

Dexmedetomidine hydrochloride has seventy-two patent family members in thirty-seven countries.

There are thirteen drug master file entries for dexmedetomidine hydrochloride. Fourteen suppliers are listed for this compound.
Summary for dexmedetomidine hydrochloride
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-( imidazolemonohydrochloride
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
MFCD22683223
MLS006011569
MolPort-003-986-435
MolPort-019-991-996
Precedex
Primadex
Q-100166
RT-012295
s2090
SCHEMBL406837
SMR004703327
ST24036207
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
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
West-ward Pharms Int DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 205046-001 Apr 26, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;IV (INFUSION) 206628-001 Oct 21, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ➤ Sign Up ➤ Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 ➤ Sign Up ➤ Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for dexmedetomidine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,436,033 Methods of treatment using a dexmedetomidine premix formulation ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for dexmedetomidine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
03C/005 Belgium ➤ Sign Up PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
1069893/01 Switzerland ➤ Sign Up FORMER OWNER: ORION CORPORATION, FI
00117 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Cantor Fitzgerald
QuintilesIMS
Medtronic
Baxter
Fuji
Moodys
Deloitte

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.