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: N206494

Product 001
AVIBACTAM SODIUM; CEFTAZIDIME (AVYCAZ) POWDER EQ 0.5GM BASE;2GM/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7112592 01/07/2026 DS DP
U-282 METHOD OF TREATING BACTERIAL INFECTIONS
U-2244 A METHOD OF TREATING BACTERIAL INFECTIONS IN HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNENUMONIA (HABP/VABP) PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM
U-2508 A METHOD OF TREATING BACTERIAL INFECTIONS IN COMPLICATED INTRA-ABDOMINAL INFECTION AND COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS, PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM
03/17/2015
001 7612087 11/12/2026 DP
03/17/2015
001 8471025 08/12/2031 DS
03/17/2015
001 8835455 10/08/2030 DP
03/17/2015
001 8969566 06/15/2032 DS
03/17/2015
001 9284314 06/15/2032 DS
02/24/2017
001 9695122 06/15/2032 DS
08/08/2017

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
02/25/2020
001
NCENEW CHEMICAL ENTITY
*GAIN GENERATING ANTIBIOTIC INCENTIVES NOW
02/25/2025

 

 


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