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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 U-2244 U-2508 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 NCE 02/25/2020
001 NCE *GAIN 02/25/2025

 

 


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