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Profile for Tradename: SPIRIVA

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Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There are twenty-seven patents protecting this drug.

This drug has two hundred and seventy-eight patent family members in fifty-six countries.

The generic ingredient in SPIRIVA is tiotropium bromide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

Summary for Tradename: SPIRIVA

Patents:27
Applicants:1
NDAs:2
Suppliers / Packagers: see list7

Pharmacology for Tradename: SPIRIVA

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

Clinical Trials for: SPIRIVA

Ultibro® Versus Spiriva® Alone to Reduce Exertional Dyspnea in Patients With Moderate to Severe COPD
Status: Not yet recruiting Condition: COPD

Dynamic Hyperinflation and Tiotropium
Status: Completed Condition: COPD

A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
Status: Recruiting Condition: Chronic Obstructive Pulmonary Disease (COPD)

Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
Status: Completed Condition: Asthma

Study to Evaluate the Effects of Tiotropium Bromide on Chronic Obstructive Pulmonary Disease (COPD) During Exercise
Status: Completed Condition: COPD

A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease
Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease; COPD

Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China
Status: Active, not recruiting Condition: Chronic Obstructive Pulmonary Disease

Efficacy in Walked Distance of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass (EMERALD)
Status: Completed Condition: COPD

Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control
Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease (COPD)

Comparison 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD
Status: Completed Condition: COPD

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 2014RXYes6,726,124<disabled>Y <disabled>
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 2014RXYes7,104,470<disabled>Y <disabled>
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 2014RXYes6,988,496<disabled>Y <disabled>
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Expired Patents for Tradename: SPIRIVA

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 20045,478,578<disabled>
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 20045,610,163<disabled>
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Non-Orange Book Patents for Tradename: SPIRIVA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,585,959 Process for preparing powder formulations<disabled in preview>
5,610,163 Esters of thienyl carboxylic acids and amino alcohols and their quaternization products<disabled in preview>
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International Patent Family for Tradename: SPIRIVA

Country Document Number Publication Date
Bulgaria107673Nov 28, 2003
Germany3931041Apr 06, 2000
Germany50103551Oct 14, 2004
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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