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Argus Health
Merck
Moodys
Boehringer Ingelheim
US Army
McKinsey
Queensland Health
Citi
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Generated: September 22, 2018

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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.

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

Drug patent expirations by year for DORIBAX
Generic Entry Opportunity Date for DORIBAX
Generic Entry Date for DORIBAX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;IV (INFUSION)

*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.

Pharmacology for DORIBAX
Ingredient-typeCarbapenems
Drug ClassPenem Antibacterial
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-[(1R)-1-HYDRO-XYETHYL]-4-METHYL-7-OXO-3-[[(3S,5S)-5-[(SULFAMOYLAMINO)-METHYL]-3-PYRROLIDINYL]THIO]-1-AZABICYCLO[3.2.0]HEPT-2-ENE-2-CARBOXYLIC ACID MONOHYDRATE
(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
364622-82-2
ABP000725
AC1L2JMJ
AJ-47442
AK326124
AKOS015918362
AM84446
AN-7043
AVAACINZEOAHHE-VFZPANTDSA-N
BCP9000623
BCPP000252
BDBM50088382
BHV525JOBH
C-23919
CAS-148016-81-3
CC-27371
CHEBI:135928
CHEMBL1721631
CHEMBL491571
CS-2075
D03895
D03QWT
D5249
DB06211
Doribax (TN)
Doripenem
Doripenem (USAN/INN)
Doripenem [USAN:INN]
Doripenem Hydrate/Doribax/S-4661/Finibax/
Doripenem monohydrate
DR002580
DRPM
DSSTox_CID_26678
DSSTox_GSID_46678
DSSTox_RID_81814
DTXSID2046678
Finibax
FT-0081127
FT-0651042
HE111624
HY-B0187
I14-8431
MFCD02092739
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

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;IV (INFUSION) 022106-002 Oct 5, 2010 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106-001 Oct 12, 2007 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ 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 DORIBAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106-002 Oct 5, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106-001 Oct 12, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for DORIBAX
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 250 mg/vial and 500 mg/vial ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for DORIBAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00003 Denmark ➤ Try a Free Trial PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
C0005 France ➤ Try a Free 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
3 Finland ➤ Try a Free Trial
0528678/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
C/GB09/006 United Kingdom ➤ Try a Free Trial PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
00374 Netherlands ➤ Try a Free Trial PRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Merck
Moodys
Boehringer Ingelheim
US Army
McKinsey
Queensland Health
Citi
Fuji

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