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Serving leading biopharmaceutical companies globally:

Julphar
Healthtrust
Cerilliant
US Department of Justice
Accenture
Argus Health
Novartis
McKinsey
US Army
Medtronic

Generated: December 11, 2017

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Doripenem - Generic Drug Details

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What are the generic sources for doripenem and what is the scope of doripenem freedom to operate?

Doripenem
is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doripenem has sixteen patent family members in fourteen countries and seven supplementary protection certificates in seven countries.

There are five drug master file entries for doripenem. Two suppliers are listed for this compound.

Pharmacology for doripenem

Ingredient-typeCarbapenems
Drug ClassPenem Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Shionogi IncDORIBAXdoripenemINJECTABLE;IV (INFUSION)022106-002Oct 5, 2010DISCNYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Shionogi IncDORIBAXdoripenemINJECTABLE;IV (INFUSION)022106-001Oct 12, 2007DISCNYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: doripenem

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi IncDORIBAXdoripenemINJECTABLE;IV (INFUSION)022106-002Oct 5, 2010► Subscribe► Subscribe
Shionogi IncDORIBAXdoripenemINJECTABLE;IV (INFUSION)022106-001Oct 12, 2007► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: doripenem

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 Ingredient: doripenem

Country Document Number Estimated Expiration
South Africa200207675► Subscribe
Brazil0109712► Subscribe
Canada2404703► Subscribe
Austria304014► Subscribe
Japan3375084► Subscribe
Australia2001244692► Subscribe
World Intellectual Property Organization (WIPO)0172750► Subscribe
Denmark1270575► Subscribe
Spain2252205► Subscribe
Germany60113243► 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: DORIPENEM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
09/002Ireland► 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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Healthtrust
AstraZeneca
Novartis
Fuji
Julphar
US Department of Justice
Fish and Richardson
Accenture
US Army

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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