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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Deloitte
Covington
QuintilesIMS
Farmers Insurance
AstraZeneca
Cerilliant
UBS
Julphar

Generated: April 22, 2018

DrugPatentWatch Database Preview

PRECEDEX Drug Profile

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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 seven patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-two patent family members in thirty-seven countries.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for PRECEDEX
Drug patent expirations by year for PRECEDEX
Pharmacology for PRECEDEX
Medical Subject Heading (MeSH) Categories for PRECEDEX
Synonyms for PRECEDEX
(+)-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
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
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 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 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 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
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 PRECEDEX

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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Paragraph IV (Patent) Challenges for PRECEDEX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 4 mcg/mL, 20 mL vials ➤ Subscribe 2015-09-30
➤ Subscribe Injection 100 mcg/mL ➤ Subscribe 2009-04-08
➤ Subscribe Injection 4 mcg/mL, 50 mL and 100 mL vials ➤ Subscribe 2013-12-26

Non-Orange Book US Patents for PRECEDEX

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 PRECEDEX

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:

Federal Trade Commission
Johnson and Johnson
Cipla
McKinsey
Cerilliant
Colorcon
Teva
UBS
Cantor Fitzgerald

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