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Profile for Tradename: BROVANA

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Brovana is a drug marketed by Sunovion and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in thirteen countries.

The generic ingredient in BROVANA is arformoterol tartrate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the arformoterol tartrate profile page.

Summary for Tradename: BROVANA

Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list4

Pharmacology for Tradename: BROVANA

Clinical Trials for: BROVANA

A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: COPD

Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: COPD

Sunovion Brovana Versus Serevent Inspiratory Capacity High Resolution Computed Tomography
Status: Recruiting Condition: Chronic Obstructive Pulmonary Disease; COPD; Emphysema; Chronic Bronchitis

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)

A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: COPD

Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT)
Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema

A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
Status: Terminated Condition: Acute Asthma

Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
Status: Terminated Condition: Exercise-induced Bronchospasm

Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Status: Completed Condition: Chronic Obstructive Pulmonary Disease; Bronchitis; Emphysema

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
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes6,814,953<disabled><disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes6,040,344<disabled>Y<disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes7,473,710<disabled><disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes7,145,036<disabled>Y<disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes8,110,706<disabled>Y<disabled>
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Paragraph IV activity for: BROVANA

Drugname Dosage Strength RLD Submissiondate
arformoterol tartrateInhalation SolutionEq. 0.015 mg base/2 mLBrovana10/1/2009

Non-Orange Book Patents for Tradename: BROVANA

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
7,964,753Formoterol tartrate process and polymorph<disabled in preview>
8,114,912Bronchodilating .beta.-agonist compositions and methods<disabled in preview>
6,268,533 Formoterol process<disabled in preview>
7,479,572Formoterol tartrate process and polymorph<disabled in preview>
7,732,641Formoterol tartrate process and polymorph<disabled in preview>
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International Patent Family for Tradename: BROVANA

Country Document Number Publication Date
Slovenia1082293Aug 31, 2004
Australia2008253696Apr 12, 2012
World Intellectual Property Organization (WIPO)0021487Apr 20, 2000
Canada2477642Feb 11, 2014
Australia5175598Jun 03, 1998
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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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