tiotropium Metered Dose Inhaler

Brand(s)
Spiriva
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-09-25)
Oldest Current Product
2014-09-30
License(s)
NDA
RxNORM
METERED DOSE INHALER\TIOTROPIUM
FDAOB
INHALATION\SPRAY, METERED\TIOTROPIUM BROMIDE\rdfq
SPL Active
RESPIRATORY (INHALATION)\SPRAY, METERED\TIOTROPIUM BROMIDE
SPL Moiety
RESPIRATORY (INHALATION)\SPRAY, METERED\TIOTROPIUM

product(s) by strength(s)

tiotropium 0.00125 mg/actuat metered dose inhaler

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970160SpirivaNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-09-15TIOTROPIUM BROMIDERESPIRATORY (INHALATION)SPRAY, METEREDNDA2070707b656b14-fcaa-2741-f6f0-e0be48971c02

tiotropium 0.0025 mg/actuat metered dose inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970100SpirivaNDABoehringer Ingelheim Pharmaceuticals, Inc.2014-09-30TIOTROPIUM BROMIDERESPIRATORY (INHALATION)SPRAY, METEREDNDA0219367b656b14-fcaa-2741-f6f0-e0be48971c02

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA021936SPIRIVA RESPIMATBOEHRINGER INGELHEIM PHARMACEUTICALS INC2014-09-24p6726124, SUBSTANCE
p6988496, SUBSTANCE
p6453795, SUBSTANCE
p5964416, SUBSTANCE
p6176442, SUBSTANCE
p7896264, SUBSTANCE
p6977042, SUBSTANCE
p7104470, SUBSTANCE
p8733341, SUBSTANCE
p7396341, SUBSTANCE
p7246615, SUBSTANCE
p6846413, SUBSTANCE
p7988001, SUBSTANCE
p9027967, SUBSTANCE
pRE39820, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, SUBSTANCE
p7284474, SUBSTANCE
p6149054, SUBSTANCE
p7802568, SUBSTANCE
p7837235, SUBSTANCE
NEW PRODUCT [2017-09-24]
NEW PRODUCT [2018-09-15]
NDA021936_001, NDA021936_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021936_001RXTIOTROPIUM BROMIDE (EQ 0.0025MG BASE/INH)SPRAY, METEREDTrue2014-09-24SPIRIVA RESPIMAT
2NDA021936_002RXTIOTROPIUM BROMIDE (EQ 0.00125MG BASE/INH)SPRAY, METEREDFalse2015-09-15SPIRIVA RESPIMAT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5964416 (view patent)2016-10-04NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
2p6149054 (view patent)2016-12-19NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
3p6176442 (view patent)2016-10-04NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
4p6453795 (view patent)2016-12-05NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
5p6726124 (view patent)2016-10-04NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
6p6846413 (view patent)2018-08-28NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
7p6977042 (view patent)2018-08-28NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
8p6988496 (view patent)2020-02-23NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
9p7104470 (view patent)2016-10-04NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
10p7246615 (view patent)2016-05-31NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
11p7284474 (view patent)2024-08-26NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
12p7396341 (view patent)2026-10-10NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
13p7802568 (view patent)2019-02-26NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
14p7837235 (view patent)2028-03-13NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
15p7896264 (view patent)2025-05-26NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
16p7988001 (view patent)2021-08-04NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
17p8733341 (view patent)2029-12-16NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
18p9027967 (view patent)2027-03-31NDA021936, NDA021747, NDA203108, NDA206756Albuterol / Ipratropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler
olodaterol Metered Dose Inhaler
19pRE39820 (view patent)2018-01-30NDA021936, NDA021395, NDA206756tiotropium Inhalant Powder
olodaterol / tiotropium Metered Dose Inhaler

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17b656b14-fcaa-2741-f6f0-e0be48971c02 (view SPL)These highlights do not include all the information needed to use SPIRIVA RESPIMAT safely and effectively. See full prescribing information for SPIRIVA RESPIMAT. SPIRIVA RESPIMAT (tiotropium bromide) inhalation spray, for oral inhalationInitial U.S. Approval: 2004prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-09-252005970100, 005970160

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