Details for New Drug Application (NDA): 206334
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NDA 206334 describes ORBACTIV, which is a drug marketed by Melinta Therap and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ORBACTIV profile page.
The generic ingredient in ORBACTIV is oritavancin diphosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.
The generic ingredient in ORBACTIV is oritavancin diphosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.
Summary for 206334
| Tradename: | ORBACTIV |
| Applicant: | Melinta Therap |
| Ingredient: | oritavancin diphosphate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206334
Generic Entry Date for 206334*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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.
Pharmacology for NDA: 206334
Suppliers and Packaging for NDA: 206334
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORBACTIV | oritavancin diphosphate | POWDER;INTRAVENOUS | 206334 | NDA | Melinta Therapeutics, LLC | 70842-140 | 70842-140-03 | 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 400MG BASE/VIAL | ||||
| Approval Date: | Aug 6, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 29, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY STREPTOCOCCUS DYSGALACTIAE WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 29, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 16, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 206334
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Melinta Therap | ORBACTIV | oritavancin diphosphate | POWDER;INTRAVENOUS | 206334-001 | Aug 6, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Melinta Therap | ORBACTIV | oritavancin diphosphate | POWDER;INTRAVENOUS | 206334-001 | Aug 6, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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