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Generated: September 24, 2017

DrugPatentWatch Database Preview

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 fifteen patent family members in fourteen countries.

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 Tradename: DORIBAX

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list42
Clinical Trials: see list3
Patent Applications: see list1,360
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DORIBAX at DailyMed

Pharmacology for Tradename: DORIBAX

Ingredient-typeCarbapenems
Drug ClassPenem Antibacterial
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)022106-002Oct 5, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Shionogi Inc
DORIBAX
doripenem
INJECTABLE;IV (INFUSION)022106-001Oct 12, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: DORIBAX

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

Drugname Dosage Strength RLD Submissiondate
doripenemInjection250 mg/vial and 500 mg/vialDoribax10/11/2011

Non-Orange Book Patents for Tradename: DORIBAX

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
9,221,823Crystal form of pyrrolidylthiocarbapenem derivative► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: DORIBAX

Country Document Number Estimated Expiration
Denmark1270575► Subscribe
Austria304014► Subscribe
MexicoPA02009592► Subscribe
Spain2252205► Subscribe
China1432016► Subscribe
Japan3375084► Subscribe
Canada2404703► Subscribe
China1192030► Subscribe
European Patent Office1270575► Subscribe
World Intellectual Property Organization (WIPO)0172750► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DORIBAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB09/006United Kingdom► SubscribePRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
00374Netherlands► SubscribePRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678/01Switzerland► SubscribePRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
2009 00003Denmark► SubscribePRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
09/002Ireland► SubscribePRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
C0005France► SubscribePRODUCT NAME: DORIPENEME; REGISTRATION NO/DATE IN FRANCE: EU/1/07/467/001 DU 20080725; REGISTRATION NO/DATE AT EEC: EU/1/08/467/001 DU 20080725
3Finland► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Queensland Health
US Army
Accenture
Baxter
Novartis
US Department of Justice
Healthtrust
Daiichi Sankyo
Cantor Fitzgerald

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 verifification 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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