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Last Updated: February 27, 2020

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DORIBAX Drug Profile


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Which patents cover Doribax, and when can generic versions of Doribax launch?

Doribax is a drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seventeen patent family members in fourteen countries.

The generic ingredient in DORIBAX is doripenem. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the doripenem profile page.

US ANDA Litigation and Generic Entry Outlook for Doribax

Doribax was eligible for patent challenges on October 12, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2021. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DORIBAX
Drug Prices for DORIBAX

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Generic Entry Opportunity Date for DORIBAX
Generic Entry Date for DORIBAX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DORIBAX

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

SponsorPhase
Janssen PharmaceuticaPhase 4
Pulmonary Associates, PAPhase 1
Keith A. RodvoldPhase 1

See all DORIBAX clinical trials

Recent Litigation for DORIBAX

Identify potential future generic entrants

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 DORIBAX litigation

Pharmacology for DORIBAX
Synonyms for DORIBAX
(+)-(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 (TN)
Doripenem
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 DORIBAX
Tradename Dosage Ingredient NDA Submissiondate
DORIBAX INJECTABLE;INTRAVENOUS doripenem 022106 2011-10-12

US Patents and Regulatory Information for DORIBAX

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 DORIBAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1270575 333 Finland   Start Trial
0528678 2009/002 Ireland   Start Trial PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678 C00528678/01 Switzerland   Start Trial PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.