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Harvard Business School
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Last Updated: January 22, 2021

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DORIBAX Drug Profile

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Which patents cover Doribax, and when can generic versions of Doribax launch?

Doribax 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.

This drug has nineteen patent family members in fifteen countries.

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.

US ANDA Litigation and Generic Entry Outlook for Doribax

Doribax was eligible for patent challenges on October 12, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2021. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DORIBAX
Drug Prices for DORIBAX

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Generic Entry Opportunity Date for DORIBAX
Generic Entry Date for DORIBAX*:
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.

Recent Clinical Trials for DORIBAX

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

Janssen PharmaceuticaPhase 4
Pulmonary Associates, PAPhase 1
Keith A. RodvoldPhase 1

See all DORIBAX clinical trials

Paragraph IV (Patent) Challenges for DORIBAX
Tradename Dosage Ingredient NDA Submissiondate
DORIBAX INJECTABLE;INTRAVENOUS doripenem 022106 2011-10-12

US Patents and Regulatory Information for DORIBAX

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   Start Trial   Start Trial Y Y   Start Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DORIBAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1270575 333 Finland   Start Trial
0528678 SPC/GB09/006 United Kingdom   Start Trial PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
0528678 300374 Netherlands   Start Trial 300374, 20120818, EXPIRES: 20170817
0528678 CR 2009 00003 Denmark   Start Trial PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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.