olodaterol / tiotropium Metered Dose Inhaler

Brand(s)
Stiolto
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-06-25)
Oldest Current Product
2015-05-21
License(s)
NDA
RxNORM
METERED DOSE INHALER\OLODATEROL:TIOTROPIUM
FDAOB
INHALATION\SPRAY, METERED\OLODATEROL HYDROCHLORIDE: TIOTROPIUM BROMIDE\rdfq
SPL Active
RESPIRATORY (INHALATION)\SPRAY, METERED\OLODATEROL HYDROCHLORIDE: TIOTROPIUM BROMIDE MONOHYDRATE
SPL Moiety
RESPIRATORY (INHALATION)\SPRAY, METERED\OLODATEROL: TIOTROPIUM

product(s) by strength(s)

olodaterol 0.0025 mg/actuat / tiotropium 0.0025 mg/actuat metered dose inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970155StioltoNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-05-21OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATERESPIRATORY (INHALATION)SPRAY, METEREDNDA20675601e15aee-40e0-23f3-537f-c96dd63e2cb1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206756STIOLTO RESPIMATBOEHRINGER INGELHEIM PHARMACEUTICALS INC2015-05-21p6726124, SUBSTANCE
p7104470, SUBSTANCE
p7786111, SUBSTANCE
p7246615, SUBSTANCE
p7056916, SUBSTANCE
p7837235, SUBSTANCE
p6988496, SUBSTANCE
p7396341, SUBSTANCE
p7988001, SUBSTANCE
p6176442, SUBSTANCE
p7727984
p7284474, SUBSTANCE
p6149054, SUBSTANCE
p5964416, SUBSTANCE
p7896264, SUBSTANCE
p6977042, SUBSTANCE
p8044046, TREATMENT OF COPD
p8733341, SUBSTANCE
p6846413, SUBSTANCE
p9027967, SUBSTANCE
pRE39820, TREATMENT OF COPD, SUBSTANCE
p8034809, TREATMENT OF COPD
p7220742, TREATMENT OF RESPIRATORY COMPLAINTS, SUBSTANCE
p7491719, SUBSTANCE
p6453795, SUBSTANCE
p7802568, SUBSTANCE
NEW CHEMICAL ENTITY [2019-07-31]
NEW COMBINATION [2018-05-21]
NDA206756_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA206756_001RXOLODATEROL HYDROCHLORIDE (EQ 0.0025MG BASE/INH), TIOTROPIUM BROMIDE (EQ 0.0025MG BASE/INH)SPRAY, METEREDTrue2015-05-21STIOLTO RESPIMAT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5964416 (view patent)2016-10-04NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
2p6149054 (view patent)2016-12-19NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
3p6176442 (view patent)2016-10-04NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
4p6453795 (view patent)2016-12-05NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
5p6726124 (view patent)2016-10-04NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
6p6846413 (view patent)2018-08-28NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
7p6977042 (view patent)2018-08-28NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
8p6988496 (view patent)2020-02-23NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
9p7056916 (view patent)2023-12-07NDA206756, NDA203108olodaterol Metered Dose Inhaler
10p7104470 (view patent)2016-10-04NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
11p7220742 (view patent)2025-05-12NDA206756, NDA203108olodaterol Metered Dose Inhaler
12p7246615 (view patent)2016-05-31NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
13p7284474 (view patent)2024-08-26NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
14p7396341 (view patent)2026-10-10NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
15p7491719 (view patent)2023-11-10NDA206756, NDA203108olodaterol Metered Dose Inhaler
16p7727984 (view patent)2023-11-10NDA206756, NDA203108olodaterol Metered Dose Inhaler
17p7786111 (view patent)2023-11-10NDA206756, NDA203108olodaterol Metered Dose Inhaler
18p7802568 (view patent)2019-02-26NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
19p7837235 (view patent)2028-03-13NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
20p7896264 (view patent)2025-05-26NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
21p7988001 (view patent)2021-08-04NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
22p8034809 (view patent)2025-05-12NDA206756, NDA203108olodaterol Metered Dose Inhaler
23p8044046 (view patent)2023-11-10NDA206756, NDA203108olodaterol Metered Dose Inhaler
24p8733341 (view patent)2029-12-16NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
25p9027967 (view patent)2027-03-31NDA206756, NDA021747, NDA021936, NDA203108tiotropium Metered Dose Inhaler
Albuterol / Ipratropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
26pRE39820 (view patent)2018-01-30NDA206756, NDA021395, NDA021936tiotropium Inhalant Powder
tiotropium Metered Dose Inhaler

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101e15aee-40e0-23f3-537f-c96dd63e2cb1 (view SPL)These highlights do not include all the information needed to use STIOLTO RESPIMAT safely and effectively. See full prescribing information for STIOLTO RESPIMAT. STIOLTO RESPIMAT (tiotropium bromide and olodaterol) inhalation spray, for oral inhalation use Initial U.S. Approval: 2015prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-252005970155

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