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Details for New Drug Application (NDA): 022106
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NDA 022106 describes DORIBAX, which is a drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DORIBAX profile page.
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.
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 022106
| Tradename: | DORIBAX |
| Applicant: | Shionogi Inc |
| Ingredient: | doripenem |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022106
Generic Entry Date for 022106*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/VIAL | ||||
| Approval Date: | Oct 12, 2007 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Mar 30, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/VIAL | ||||
| Approval Date: | Oct 5, 2010 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Mar 30, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 022106
| 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 |
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