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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-five patents protecting this drug.

This drug has two hundred and seventy-seven 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:25
Applicants:1
NDAs:2
Suppliers / Packagers: see list7

Pharmacology for Tradename: SPIRIVA

Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

Clinical Trials for: SPIRIVA

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Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease; COPD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: Recruiting 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Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease (COPD)

Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers
Status: Completed Condition: Healthy

Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease; Bronchitis; Emphysema

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, 2014RXYes<disabled><disabled>
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 2004RXYes6,908,928<disabled>YY<disabled>
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 2014RXYes5,964,416<disabled>Y<disabled>
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 2014RXYes6,846,413<disabled>Y<disabled>
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 2004RXYes7,694,676<disabled>Y<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
Israel209401Jan 31, 2011
Japan2004526668Sep 02, 2004
European Patent Office1326862Sep 15, 2004
Australia642913Nov 04, 1993
China100522135Aug 05, 2009
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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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