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. 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. Additional details are available on the doripenem profile page.

Summary for 022106

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

Generic Entry Opportunity Date for 022106

Generic Entry Date for 022106^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial 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.

Paragraph IV (Patent) Challenges for 022106

Tradename	Dosage	Ingredient	NDA	Submissiondate
DORIBAX	INJECTABLE;INTRAVENOUS	doripenem	022106	2011-10-12

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Oct 12, 2007	TE:		RLD:	Yes
Patent:	Start 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;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	Oct 5, 2010	TE:		RLD:	Yes
Patent:	Start 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;INTRAVENOUS	022106-002	Oct 5, 2010	Start Trial	Start Trial
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.

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