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Doripenem - Generic Drug Details
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. 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.
Summary for doripenem
| International Patents: | 19 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 5 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 29 |
| Patent Applications: | 3,456 |
| 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 |
| National University Hospital, Singapore | 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-002 | Oct 5, 2010 | 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 |
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 | Start Trial | Start Trial |
| Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-001 | Oct 12, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for doripenem
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 0109712 | Start Trial |
| Germany | 60113243 | Start Trial |
| Brazil | PI0109712 | Start Trial |
| Spain | 2252205 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for doripenem
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0528678 | C300374 | Netherlands | Start Trial | PRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725 |
| 1270575 | 333 | Finland | Start Trial | |
| 0528678 | 2009/002 | Ireland | Start Trial | PRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725 |
| 0528678 | SPC/GB09/006 | United Kingdom | Start Trial | PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
