Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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: N210595

Product 001
ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE (DUAKLIR PRESSAIR) POWDER, METERED 0.4MG/INH;0.012MG/INH

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6681768 08/07/2022 DP
04/24/2019
001 7078412 07/07/2020 DS DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019
001 7750023 07/07/2020 DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019
001 8051851 04/22/2027 DP
04/24/2019
001 8129405 07/07/2020 DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019
001 9056100 07/07/2020 DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019
001 9333195 07/07/2020 DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019
001 10034867 07/07/2020 DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
U-2514 MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019
001 10085974 03/13/2029 DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019
001 10588895 07/07/2020
U-2772 MAINTENANCE TREATMENT OF CHRONIC PULMONARY DISEASE (COPD)
04/09/2020
001 RE46417 02/10/2025 DS DP
U-2513 MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
04/24/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCNEW COMBINATION
COMPETITIVE GENERIC THERAPY
03/29/2022

 

 


View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English