umeclidinium / vilanterol Dry Powder Inhaler

Brand(s)
Anoro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-05-09)
Oldest Current Product
2014-01-31
License(s)
NDA
RxNORM
DRY POWDER INHALER\UMECLIDINIUM:VILANTEROL
FDAOB
INHALATION\POWDER\UMECLIDINIUM BROMIDE: VILANTEROL TRIFENATATE\rdfq
SPL Active
RESPIRATORY (INHALATION)\POWDER\UMECLIDINIUM BROMIDE: VILANTEROL TRIFENATATE
SPL Moiety
RESPIRATORY (INHALATION)\POWDER\UMECLIDINIUM: VILANTEROL

product(s) by strength(s)

umeclidinium 0.0625 mg/actuat / vilanterol 0.025 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730869AnoroNDAGlaxosmithkline Llc2014-01-31UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATERESPIRATORY (INHALATION)POWDERNDA2039752dbd0671-c565-40c5-bf0f-e324db26799c

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203975ANORO ELLIPTAGLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND2013-12-18p8113199, SUBSTANCE
p8746242, SUBSTANCE
pRE44874, INDICATED FOR THE LONG-TERM, SUBSTANCE
p8309572, INDICATED FOR THE LONG-TERM
p7439393, INDICATED FOR THE LONG-TERM, SUBSTANCE
p8511304, INDICATED FOR THE LONG-TERM, SUBSTANCE
p7498440, SUBSTANCE
p7488827, SUBSTANCE
p7776895, SUBSTANCE
p8183257, INDICATED FOR THE LONG-TERM
p8161968, SUBSTANCE
p8534281, SUBSTANCE
p5873360, SUBSTANCE
NEW PRODUCT [2016-12-18]NDA203975_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA203975_001RXVILANTEROL TRIFENATATE (EQ 0.025MG BASE/INH), UMECLIDINIUM BROMIDE (EQ 0.0625MG BASE/INH)POWDERTrue2013-12-18ANORO ELLIPTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5873360 (view patent)2016-02-23NDA203975, NDA020692, NDA020833, NDA021077, NDA204275, NDA205382, NDA205625fluticasone / salmeterol Dry Powder Inhaler
fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
salmeterol Dry Powder Inhaler
2p7439393 (view patent)2022-09-11NDA203975, NDA204275fluticasone / vilanterol Dry Powder Inhaler
3p7488827 (view patent)2025-04-27NDA203975, NDA205382umeclidinium Dry Powder Inhaler
4p7498440 (view patent)2025-04-27NDA203975, NDA205382umeclidinium Dry Powder Inhaler
5p7776895 (view patent)2022-09-11NDA203975, NDA204275fluticasone / vilanterol Dry Powder Inhaler
6p8113199 (view patent)2027-10-23NDA203975, NDA204275, NDA205382, NDA205625fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
7p8161968 (view patent)2028-02-05NDA203975, NDA204275, NDA205382, NDA205625fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
8p8183257 (view patent)2025-07-27NDA203975, NDA205382umeclidinium Dry Powder Inhaler
9p8309572 (view patent)2025-04-27NDA203975, NDA205382umeclidinium Dry Powder Inhaler
10p8511304 (view patent)2027-06-14NDA203975, NDA204275fluticasone / vilanterol Dry Powder Inhaler
11p8534281 (view patent)2029-08-10NDA203975, NDA204275, NDA205382, NDA205625fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
12p8746242 (view patent)2030-10-11NDA203975, NDA204275, NDA205382, NDA205625fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
13pRE44874 (view patent)2023-03-23NDA203975, NDA204275fluticasone / vilanterol Dry Powder Inhaler

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12dbd0671-c565-40c5-bf0f-e324db26799c (view SPL)These highlights do not include all the information needed to use the ANORO ELLIPTA inhaler safely and effectively. See full prescribing information for ANORO ELLIPTA.ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder)FOR ORAL INHALATION USEInitial U.S. Approval: 2013prescriptionHuman PrescriptionGlaxosmithkline Llc2014-05-097001730869

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