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Serving leading biopharmaceutical companies globally:

Julphar
Medtronic
Deloitte
Accenture
US Army
Johnson and Johnson
Mallinckrodt
QuintilesIMS
Citi
Novartis

Generated: February 19, 2018

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 sixteen 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 DORIBAX
Drug patent expirations by year for DORIBAX
Pharmacology for DORIBAX
Ingredient-typeCarbapenems
Drug ClassPenem Antibacterial

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;IV (INFUSION) 022106-002 Oct 5, 2010 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Shionogi Inc DORIBAX doripenem INJECTABLE;IV (INFUSION) 022106-001 Oct 12, 2007 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for DORIBAX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 250 mg/vial and 500 mg/vial ➤ Subscribe 10/11/2011

Non-Orange Book US Patents for 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
9,221,823 Crystal form of pyrrolidylthiocarbapenem derivative ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for DORIBAX

Supplementary Protection Certificates for DORIBAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0528678/01 Switzerland ➤ Sign Up PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
C0005 France ➤ Sign Up PRODUCT 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
3 Finland ➤ Sign Up
00374 Netherlands ➤ Sign Up PRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
09/002 Ireland ➤ Sign Up PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
2009 00003 Denmark ➤ Sign Up PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
C/GB09/006 United Kingdom ➤ Sign Up PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
US Department of Justice
Teva
McKesson
Express Scripts
Citi
Fish and Richardson
Colorcon

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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