DORIBAX Drug Patent Profile
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Which patents cover Doribax, 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.
Summary for DORIBAX
Recent Clinical Trials for DORIBAX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Pharmaceutica | |
Keith A. Rodvold | Phase 1 |
Pulmonary Associates, PA | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for DORIBAX
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 | 022106-001 | 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 |
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 |
>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 |
---|---|---|---|
Brazil | PI0109712 | forma de cristal de derivado de pirroliditiocarbapenemo | ⤷ Try a Trial |
Greece | 3036434 | ⤷ Try a Trial | |
European Patent Office | 0557122 | Méthode de production de sulphamide (A production method for sulfamide) | ⤷ Try a Trial |
China | 1078718 | ⤷ Try a Trial | |
Canada | 2203942 | DERIVE DE PYRROLIDYLTHIOCARBAPENEME (A 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 | C300374 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725 |
0528678 | 91519 | Luxembourg | ⤷ Try a Trial | 91519, EXPIRES: 20170818 |
0528678 | 09C0005 | France | ⤷ Try a 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 | CR 2009 00003 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725 |
1270575 | 333 | Finland | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |