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Last Updated: March 28, 2024

Doribax Drug Patent Profile


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When do Doribax patents expire, and what generic alternatives are available?

Doribax is a drug marketed by Shionogi Inc and is included in one NDA.

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.

Drug patent expirations by year for Doribax
Drug Prices for Doribax

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Recent Clinical Trials for Doribax

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SponsorPhase
Janssen Pharmaceutica
Keith A. RodvoldPhase 1
Pulmonary Associates, PAPhase 1

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Paragraph IV (Patent) Challenges for DORIBAX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DORIBAX Injection doripenem 250 mg/vial and 500 mg/vial 022106 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Doribax

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for Doribax

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International NV Doribax doripenem EMEA/H/C/000891
Doribax is indicated for the treatment of the following infections in adults:nosocomial pneumonia (including ventilator-associated pneumonia);complicated intra-abdominal infections;complicated urinary tract infections.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Withdrawn no no no 2008-07-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for Doribax

See the table below for patents covering Doribax around the world.

Country Patent Number Title Estimated Expiration
Greece 3022542 ⤷  Try a Trial
European Patent Office 0557122 Méthode de production de sulphamide (A production method for sulfamide) ⤷  Try a Trial
Canada 2404703 NOUVELLE FORME CRISTALLINE D'UN DERIVE DE PYRROLIDYLTHIOCARBAPENEM (NOVEL CRYSTAL FORM OF PYRROLIDYLTHIOCARBAPENEM DERIVATIVE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for Doribax

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0528678 C00528678/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
0528678 300374 Netherlands ⤷  Try a Trial 300374, 20120818, EXPIRES: 20170817
0528678 91519 Luxembourg ⤷  Try a Trial 91519, EXPIRES: 20170818
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.