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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.

Summary for doripenem

International Patents:	17
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Suppliers / Packagers:	1
Bulk Api Vendors:	54
Clinical Trials:	29
Patent Applications:	3,349
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for doripenem
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doripenem
DailyMed Link:	doripenem at DailyMed

See drug prices for doripenem

Recent Clinical Trials for doripenem

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

Sponsor	Phase
Postgraduate Institute of Medical Education and Research	Phase 3
National University Hospital, Singapore	Phase 2/Phase 3
Singapore General Hospital	Phase 2/Phase 3

See all doripenem clinical trials

Recent Litigation for doripenem

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Drug Class

Penem Antibacterial

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			Y	Y
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007		DISCN	Yes	No			Y	Y

Expired US Patents for doripenem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007

International Patents for doripenem

Country	Patent Number	Estimated Expiration
Brazil	0109712
Taiwan	I293631
Denmark	1270575
Spain	2252205
Japan	3375084
Germany	60113243
Austria	304014

Supplementary Protection Certificates for doripenem

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