Details for New Drug Application (NDA): 214155
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NDA 214155 describes KIMYRSA, which is a drug marketed by Melinta Therap and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the KIMYRSA profile page.
The generic ingredient in KIMYRSA is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.
The generic ingredient in KIMYRSA is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.
Summary for 214155
| Tradename: | KIMYRSA |
| Applicant: | Melinta Therap |
| Ingredient: | oritavancin diphosphate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214155
Generic Entry Date for 214155*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW 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: 214155
Suppliers and Packaging for NDA: 214155
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KIMYRSA | oritavancin diphosphate | POWDER;INTRAVENOUS | 214155 | NDA | Melinta Therapeutics, LLC | 70842-225 | 70842-225-01 | 1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1.2GM BASE/VIAL | ||||
| Approval Date: | Mar 12, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 6, 2024 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Aug 6, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 12, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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