Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N021883

Product 001
DALBAVANCIN HYDROCHLORIDE (DALVANCE) POWDER EQ 500MG BASE/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6900175 12/25/2023
U-1517 TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
06/13/2014
001 7115564 11/14/2023 DP
06/13/2014
001 7119061 11/14/2023 DP
06/13/2014
001 8143212 11/14/2023
U-1517 TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
06/13/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
05/23/2019
001
NCENEW CHEMICAL ENTITY
*GAIN GENERATING ANTIBIOTIC INCENTIVES NOW
05/23/2024
001
NPPNEW PATIENT POPULATION
COMPETITIVE GENERIC THERAPY
07/22/2024

 

 


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