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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 thirty-three patent family members in forty-nine countries.

The generic ingredient in SPIRIVA is tiotropium bromide. There are six 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: see list3

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Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease; COPD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

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Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease (COPD)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

The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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>
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International Patent Family for Tradename: SPIRIVA

Country Document Number Publication Date
European Patent Office1430887Jun 23, 2004
Austria369365Aug 15, 2007
China1392795Jan 22, 2003
MexicoPA04009056Jan 25, 2005
Brazil0309117Feb 01, 2005
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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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