DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021883
The generic ingredient in DALVANCE is dalbavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.
Summary for 021883
Tradename: | DALVANCE |
Applicant: | Allergan Sales Llc |
Ingredient: | dalbavancin hydrochloride |
Patents: | 4 |
Generic Entry Opportunity Date for 021883
Generic Entry Date for 021883*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
POWDER;IV (INFUSION) |
*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: 021883
Suppliers and Packaging for NDA: 021883
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DALVANCE | dalbavancin hydrochloride | POWDER;INTRAVENOUS | 021883 | NDA | Durata Therapeutics Inc. | 57970-100 | 57970-100-01 | 1 VIAL in 1 PACKAGE (57970-100-01) > 25 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | May 23, 2014 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jan 20, 2019 | ||||||||
Regulatory Exclusivity Use: | ADDITION OF A 1500MG-SINGLE-DOSE REGIMEN FOR THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSI) | ||||||||
Regulatory Exclusivity Expiration: | May 23, 2024 | ||||||||
Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
Regulatory Exclusivity Expiration: | May 23, 2019 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY |
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