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  • 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.
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Patent and Exclusivity for: N204275

Product 001
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE (BREO ELLIPTA) POWDER 0.1MG/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
001 6537983 08/03/2021 DP
U-1401 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
U-1691 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
06/04/2013
001 6759398 08/03/2021 DP
U-1401 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
U-1691 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
06/04/2013
001 6878698 08/03/2021
U-1401 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
06/04/2013
001 7101866 08/03/2021 DS DP
U-1401 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
U-1691 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
06/04/2013
001 7439393 05/21/2025 DS DP
U-1401 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
U-1691 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
U-2099 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA
U-2100 INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER
06/04/2013
001 7629335 08/03/2021 DP
06/04/2013
001 7776895 09/11/2022 DP
06/04/2013
001 8113199 10/23/2027 DP
06/04/2013
001 8161968 02/05/2028 DP
06/04/2013
001 8511304 06/14/2027 DP
U-1424 LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-1691 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
09/06/2013
001 8534281 03/08/2030 DP
09/18/2013
001 8746242 10/11/2030 DP
07/08/2014
001 9333310 10/02/2027 DP
05/20/2016
001 RE44874 03/23/2023 DS DP
U-1548 FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-1691 INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
06/27/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-708 DAILY TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER
COMPETITIVE GENERIC THERAPY
04/30/2018
001
NCE NEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
05/10/2018
001
M-202 INCLUSION OF DATA FROM THE SUMMIT STUDY FOR BREO ELLIPTA (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE) INHALATION POWDER IN THE PACKAGE INSERT.
COMPETITIVE GENERIC THERAPY
05/15/2020

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