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: N202236

Product 001
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE (DYMISTA) SPRAY, METERED 0.137MG/SPRAY;0.05MG/SPRAY

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8163723 08/29/2023
U-77 TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
U-81 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
U-644 TREATMENT OF SEASONAL ALLERGIC RHINITIS
U-707 ALLERGIC RHINITIS
U-1667 TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL ALLERGIC RHINITIS
05/11/2012
001 8163723*PED 02/29/2024
001 8168620 02/24/2026 DP
05/11/2012
001 8168620*PED 08/24/2026
001 9259428 06/13/2023
U-644 TREATMENT OF SEASONAL ALLERGIC RHINITIS
03/09/2016
001 9259428*PED 12/13/2023
001 9901585 06/13/2023 DP
03/27/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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