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Last Updated: March 28, 2024

Doripenem - Generic Drug Details


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

Doripenem is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for doripenem.

Drug Prices for doripenem

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Recent Clinical Trials for doripenem

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 3
Changi General HospitalPhase 2/Phase 3
Singapore General HospitalPhase 2/Phase 3

See all doripenem clinical trials

Paragraph IV (Patent) Challenges for DORIPENEM
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 doripenem

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 022106-001 Oct 12, 2007 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 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 doripenem

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
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 doripenem

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

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