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Last Updated: February 26, 2020

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Doripenem - Generic Drug Details

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

Doripenem is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doripenem has seventeen patent family members in fourteen countries.

There are five drug master file entries for doripenem. One supplier is listed for this compound.

Drug Prices for doripenem

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Recent Clinical Trials for doripenem

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SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 3
National University Hospital, SingaporePhase 2/Phase 3
Singapore General HospitalPhase 2/Phase 3

See all doripenem clinical trials

Recent Litigation for doripenem

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District Court Litigation
Case NameDate
SHIONOGI & CO., LTD. v. APOTEX CORP.2015-01-30
Shionogi & Co., Ltd. v. Aurobindo Pharma Ltd.2015-01-16
SHIONOGI & CO., LTD. v. SANDOZ INC.2012-12-28

See all doripenem litigation

Pharmacology for doripenem
Synonyms for doripenem
(+)-(4R,5S,6S)-6-((1R)-1-Hydroxyethyl)-4-methyl-7-oxo-3-(((3S,5S)-5-((sulfamoylamino)methyl)-3-pyrrolidinyl)thio)-1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid
(4R,5S,6S)-6-((R)-1-hydroxyethyl)-4-methyl-7-oxo-3-(((3S,5S)-5-((sulfamoylamino)methyl)pyrrolidin-3-yl)thio)-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
(4R,5S,6S)-6-((R)-1-hydroxyethyl)-4-Methyl-7-oxo-3-((3S,5S)-5-((sulfaMoylaMino)Methyl)pyrrolidin-3-ylthio)-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
(4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-3-[(3S,5S)-5-[(sulfamoylamino)methyl]pyrrolidin-3-yl]sulfanyl-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
(4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-3-{[(3S,5S)-5-[(sulfamoylamino)methyl]pyrrolidin-3-yl]sulfanyl}-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
016D813
1-Azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid, 3-(((3S,5S)-5-(((aminosulfonyl)amino)methyl)-3-pyrrolidinyl)thio)-6-((1R)-1-hydroxyethyl)-4-methyl-7-oxo-, (4R,5S,6S)-
1-Azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid, 3-((5-(((aminosulfonyl)amino)methyl)-3-pyrrolidinyl)thio)-6-(1-hydroxyethyl)-4-methyl-7-oxo-, (4R-(3(3S*,5S*),4alpha,5beta,6beta(R*)))-
148016-81-3
ABP000725
AC1L2JMJ
AJ-47442
AKOS015918362
AM84446
AN-7043
AVAACINZEOAHHE-VFZPANTDSA-N
BCP9000623
BCPP000252
BDBM50088382
BHV525JOBH
C-23919
CAS-148016-81-3
CC-27371
CHEBI:135928
CHEMBL491571
CS-2075
D03895
D5249
DB06211
Doribax
Doribax (TN)
Doripenem (USAN/INN)
Doripenem [USAN:INN]
Doripenem hydrate
Doripenem Hydrate/Doribax/S-4661/Finibax/
Doripenem monohydrate
DRPM
DSSTox_CID_26678
DSSTox_GSID_46678
DSSTox_RID_81814
DTXSID2046678
Finibax
FT-0081127
FT-0651042
HY-B0187
I14-8431
MFCD09749887
MolPort-006-069-366
NCGC00167510-01
NCGC00167510-02
RL01870
S 4661
S-4661
SCHEMBL37471
SR-01000872589
SR-01000872589-1
ST2401965
Tox21_112508
Tox21_112508_1
UNII-BHV525JOBH
ZINC3922770
Paragraph IV (Patent) Challenges for DORIPENEM
Tradename Dosage Ingredient NDA Submissiondate
DORIBAX INJECTABLE;INTRAVENOUS doripenem 022106 2011-10-12

US Patents and Regulatory Information for doripenem

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 DISCN Yes No   Start Trial   Start Trial Y 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

Supplementary Protection Certificates for doripenem

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0528678 C300374 Netherlands   Start Trial PRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678 09C0005 France   Start Trial PRODUCT NAME: DORIPENEME; REGISTRATION NO/DATE IN FRANCE: EU/1/07/467/001 DU 20080725; REGISTRATION NO/DATE AT EEC: EU/1/08/467/001 DU 20080725
0528678 CR 2009 00003 Denmark   Start Trial PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
0528678 SPC/GB09/006 United Kingdom   Start Trial PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
0528678 C00528678/01 Switzerland   Start Trial PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
1270575 333 Finland   Start Trial
0528678 2009/002 Ireland   Start Trial PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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