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Harvard Business School
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Last Updated: February 27, 2021

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. 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
Applicant:Shionogi Inc
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022106
Generic Entry Date for 022106*:
Constraining patent/regulatory exclusivity:

*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

Approval Date:Oct 12, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 30, 2021Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Approval Date:Oct 5, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 30, 2021Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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.