fluticasone / vilanterol Dry Powder Inhaler

Brand(s)
Breo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-09-18)
Oldest Current Product
2013-08-26
License(s)
NDA
RxNORM
DRY POWDER INHALER\FLUTICASONE:VILANTEROL
FDAOB
INHALATION\POWDER\FLUTICASONE FUROATE: VILANTEROL TRIFENATATE\rdfq
SPL Active
RESPIRATORY (INHALATION)\POWDER\FLUTICASONE FUROATE: VILANTEROL TRIFENATATE
SPL Moiety
RESPIRATORY (INHALATION)\POWDER\FLUTICASONE: VILANTEROL

product(s) by strength(s)

fluticasone furoate 0.1 mg/actuat / vilanterol 0.025 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730859BreoNDAGlaxosmithkline Llc2013-08-26FLUTICASONE FUROATE, VILANTEROL TRIFENATATERESPIRATORY (INHALATION)POWDERNDA20427596428df1-ea05-431a-98d3-1ec2c4b63878

fluticasone furoate 0.2 mg/actuat / vilanterol 0.025 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730882BreoNDAGlaxosmithkline Llc2015-04-30FLUTICASONE FUROATE, VILANTEROL TRIFENATATERESPIRATORY (INHALATION)POWDERNDA20427596428df1-ea05-431a-98d3-1ec2c4b63878

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204275BREO ELLIPTAGLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE2013-05-10p8113199, SUBSTANCE
p7101866, INDICATED FOR LONG-TERM/ INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER, SUBSTANCE
p6878698, INDICATED FOR LONG-TERM
p7629335, SUBSTANCE
p6537983, INDICATED FOR LONG-TERM/ INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER, SUBSTANCE
p7439393, INDICATED FOR LONG-TERM/ INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER, SUBSTANCE
p5873360, SUBSTANCE
p8511304, INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER/ LONG-TERM, SUBSTANCE
p8746242, SUBSTANCE
p7776895, SUBSTANCE
p8161968, SUBSTANCE
pRE44874, INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER/ FOR THE LONG-TERM, SUBSTANCE
p8534281, SUBSTANCE
p6759398, INDICATED FOR LONG-TERM/ INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER, SUBSTANCE
DAILY TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER [2018-04-30]
NEW PRODUCT [2016-05-10]
NEW PRODUCT [2018-04-30]
NDA204275_001, NDA204275_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA204275_001RXFLUTICASONE FUROATE (0.1MG/INH), VILANTEROL TRIFENATATE (EQ 0.025MG BASE/INH)POWDERTrue2013-05-10BREO ELLIPTA
2NDA204275_002RXFLUTICASONE FUROATE (0.2MG/INH), VILANTEROL TRIFENATATE (EQ 0.025MG BASE/INH)POWDERFalse2015-04-30BREO ELLIPTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5873360 (view patent)2016-02-23NDA204275, NDA020692, NDA020833, NDA021077, NDA203975, NDA205382, NDA205625fluticasone / salmeterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
salmeterol Dry Powder Inhaler
2p6537983 (view patent)2021-08-03NDA204275
3p6759398 (view patent)2021-08-03NDA204275
4p6878698 (view patent)2021-08-03NDA204275
5p7101866 (view patent)2021-08-03NDA204275, NDA022051, NDA205625fluticasone Nasal Inhaler
fluticasone Dry Powder Inhaler
6p7439393 (view patent)2022-09-11NDA204275, NDA203975umeclidinium / vilanterol Dry Powder Inhaler
7p7629335 (view patent)2021-08-03NDA204275, NDA205625fluticasone Dry Powder Inhaler
8p7776895 (view patent)2022-09-11NDA204275, NDA203975umeclidinium / vilanterol Dry Powder Inhaler
9p8113199 (view patent)2027-10-23NDA204275, NDA203975, NDA205382, NDA205625umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
10p8161968 (view patent)2028-02-05NDA204275, NDA203975, NDA205382, NDA205625umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
11p8511304 (view patent)2027-06-14NDA204275, NDA203975umeclidinium / vilanterol Dry Powder Inhaler
12p8534281 (view patent)2029-08-10NDA204275, NDA203975, NDA205382, NDA205625umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
13p8746242 (view patent)2030-10-11NDA204275, NDA203975, NDA205382, NDA205625umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
14pRE44874 (view patent)2023-03-23NDA204275, NDA203975umeclidinium / vilanterol Dry Powder Inhaler

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
196428df1-ea05-431a-98d3-1ec2c4b63878 (view SPL)These highlights do not include all the information needed to use BREO ELLIPTA safely and effectively. See full prescribing information for BREO ELLIPTA.BREO ELLIPTA 100/25 (fluticasone furoate 100mcg and vilanterol 25mcg inhalation powder), for oral inhalationBREO ELLIPTA 200/25 (fluticasone furoate 200mcg and vilanterol 25mcg inhalation powder), for oral inhalationInitial U.S. Approval: 2013prescriptionHuman PrescriptionGlaxosmithkline Llc2015-09-188001730859, 001730882

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII