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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022106

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NDA 022106 describes DORIBAX, which is a drug marketed by Shionogi Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DORIBAX profile page.

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.

Summary for 022106

Tradename:	DORIBAX
Applicant:	Shionogi Inc
Ingredient:	doripenem
Patents:	1
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022106

Ingredient-type	Carbapenems

Suppliers and Packaging for NDA: 022106

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DORIBAX	doripenem	INJECTABLE;IV (INFUSION)	022106	NDA	Shionogi Inc.	59630-309	N	59630-309-10
DORIBAX	doripenem	INJECTABLE;IV (INFUSION)	022106	NDA	Shionogi Inc.	59630-320	N	59630-320-10

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;IV (INFUSION)			Strength	500MG/VIAL
Approval Date:	Oct 12, 2007	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Mar 30, 2021	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;IV (INFUSION)			Strength	250MG/VIAL
Approval Date:	Oct 5, 2010	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Mar 30, 2021	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 022106

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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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