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.
Summary for doripenem
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 69 |
Clinical Trials: | 29 |
Patent Applications: | 6,541 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for doripenem |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for doripenem |
DailyMed Link: | doripenem at DailyMed |
Recent Clinical Trials for doripenem
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Postgraduate Institute of Medical Education and Research | Phase 3 |
Changi General Hospital | Phase 2/Phase 3 |
Singapore General Hospital | Phase 2/Phase 3 |
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 |