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Last Updated: March 7, 2021

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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 patent protection?

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 nineteen patent family members in fifteen countries.

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

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

See all doripenem clinical trials

Paragraph IV (Patent) Challenges for DORIPENEM
Tradename Dosage Ingredient NDA Submissiondate
DORIBAX INJECTABLE;INTRAVENOUS doripenem 022106 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 022106-002 Oct 5, 2010 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for doripenem

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0528678 C00528678/01 Switzerland   Start Trial PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
0528678 09C0005 France   Start Trial 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
0528678 2009/002 Ireland   Start Trial PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Harvard Business School

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