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: N209482

Product 002
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) POWDER 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6537983 08/03/2021 DP
U-2125 THE TREATMENT OF AN INFLAMMATORY DISORDER OF THE RESPIRATORY TRACT BY ONCE-PER-DAY ADMINISTRATION OF A PHARMACEUTICAL FORMULATION COMPRISING FLUTICASONE FUROATE AND A LONG-ACTING BETA2 ADRENORECEPTOR AGONIST
10/06/2020
002 6759398 08/03/2021 DP
U-2125 THE TREATMENT OF AN INFLAMMATORY DISORDER OF THE RESPIRATORY TRACT BY ONCE-PER-DAY ADMINISTRATION OF A PHARMACEUTICAL FORMULATION COMPRISING FLUTICASONE FUROATE AND A LONG-ACTING BETA2 ADRENORECEPTOR AGONIST
10/06/2020
002 7101866 08/03/2021 DS DP
U-2953 USE OF FLUTICASONE FUROATE FOR THE TREATMENT OF AN INFLAMMATORY OR ALLERGIC CONDITIONS, INCLUDING CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND ASTHMA
10/06/2020
002 7439393 05/21/2025 DS DP
U-2957 MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
10/06/2020
002 7488827 12/18/2027 DS DP
10/06/2020
002 7498440 04/27/2025 DS DP
10/06/2020
002 7629335 08/03/2021 DP
10/06/2020
002 7776895 09/11/2022 DP
10/06/2020
002 8113199 10/23/2027 DP
10/06/2020
002 8161968 02/05/2028 DP
10/06/2020
002 8183257 07/27/2025
U-2129 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
10/06/2020
002 8309572 04/27/2025
U-2129 METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION
10/06/2020
002 8511304 06/14/2027 DP
U-2954 METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD
10/06/2020
002 8534281 03/08/2030 DP
10/06/2020
002 8746242 10/11/2030 DP
10/06/2020
002 9333310 10/02/2027 DP
10/06/2020
002 9750726 11/29/2030 DP
10/06/2020
002 RE44874 03/23/2023 DS DP
U-2955 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA
10/06/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NSNEW STRENGTH
COMPETITIVE GENERIC THERAPY
09/09/2023

 

 


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