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Last Updated: November 2, 2024

DORIBAX Drug Patent 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.

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.

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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
Pulmonary Associates, PAPhase 1
Janssen-Cilag Ltd.,ThailandPhase 4

See all DORIBAX clinical trials

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 022106-001 Oct 12, 2007 ⤷  Sign Up ⤷  Sign Up
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 ⤷  Sign Up ⤷  Sign Up
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 ⤷  Sign Up ⤷  Sign Up
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 ⤷  Sign Up ⤷  Sign Up
>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

Supplementary Protection Certificates for DORIBAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0528678 CR 2009 00003 Denmark ⤷  Sign Up PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
0528678 2009/002 Ireland ⤷  Sign Up PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
0528678 91519 Luxembourg ⤷  Sign Up 91519, EXPIRES: 20170818
0528678 C00528678/01 Switzerland ⤷  Sign Up PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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