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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Medtronic
McKesson
Express Scripts
McKinsey
Covington
Baxter
Healthtrust

Generated: July 16, 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 nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are thirteen drug master file entries for dexmedetomidine hydrochloride. Sixteen suppliers are listed for this compound.
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
Fresenius Kabi Usa DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 201072-001 Sep 18, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;IV (INFUSION) 206628-003 Jun 22, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sun Pharm Inds Inc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202126-001 Aug 20, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 021038-001 Dec 17, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
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
00117 Netherlands ➤ Try a Free 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
1069893/01 Switzerland ➤ Try a Free Trial FORMER OWNER: ORION CORPORATION, FI
03C/005 Belgium ➤ Try a Free Trial PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
Chinese Patent Office
Julphar
Cantor Fitzgerald
Accenture
QuintilesIMS
Merck
Mallinckrodt

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