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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 doripenem 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 sixteen patent family members in fourteen countries.

There are five drug master file entries for doripenem. Two suppliers are listed for this compound.

Summary for doripenem

International Patents:	16
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Suppliers / Packagers:	2
Bulk Api Vendors:	51
Clinical Trials:	28
Patent Applications:	2,580
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doripenem
DailyMed Link:	doripenem at DailyMed

Pharmacology for doripenem

Ingredient-type	Carbapenems
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-[(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

Doribax (TN)

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

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Expired US Patents for doripenem

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

Non-Orange Book US Patents for doripenem

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
9,221,823	Crystal form of pyrrolidylthiocarbapenem derivative

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International Patents for doripenem

Country	Document Number	Estimated Expiration
Mexico	PA02009592
Austria	304014
European Patent Office	1270575
World Intellectual Property Organization (WIPO)	0172750

Supplementary Protection Certificates for doripenem

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB09/006	United Kingdom		PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
3	Finland
09/002	Ireland		PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
2009 00003	Denmark		PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725