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: N021929

Product 002
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE (SYMBICORT) AEROSOL, METERED 0.16MG/INH;0.0045MG/INH

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7587988 04/10/2026 DP
002 7587988*PED 10/10/2026
002 7759328 01/29/2023 DP
U-2001 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
U-2002 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
U-2122 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
002 7759328*PED 07/29/2023
002 7967011 08/11/2021 DP
002 7967011*PED 02/11/2022
002 8143239 01/29/2023 DP
U-2001 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
U-2002 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
U-2122 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
002 8143239*PED 07/29/2023
002 8387615 03/26/2027 DP
002 8387615*PED 09/26/2027
002 8528545 10/16/2028 DP
10/09/2013
002 8528545*PED 04/16/2029
002 8575137 01/29/2023 DP
U-2001 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
U-2002 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
U-2122 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
12/04/2013
002 8575137*PED 07/29/2023
002 8616196 04/07/2029 DP
01/29/2014
002 8616196*PED 10/07/2029
002 8875699 11/10/2024 DP
12/12/2014
002 8875699*PED 05/10/2025
002 10166247 01/29/2023 DP
U-2001 USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
U-2002 USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
U-2122 USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
01/07/2019
002 10166247*PED 07/29/2023

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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