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Profile for Tradename: ADVAIR HFA

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Advair Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug.

The generic ingredient in ADVAIR HFA is fluticasone propionate; salmeterol xinafoate. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

Summary for Tradename: ADVAIR HFA

Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list9
Formulation / Manufacturing:see details

Clinical Trials for: ADVAIR HFA

A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
Status: Completed Condition: Asthma

Onset of Action of Advair Hydrofluoroalkane (HFA) 115/21 in Comparison to Symbicort Pressurised Metered-Dose Inhalers (pMDI) 160/4.5 Measured by Impulse Oscillometry (IOS)
Status: Recruiting Condition: Asthma

The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD
Status: Withdrawn Condition: Chronic Obstructive Pulmonary Disease; Sleep Disorders

MGR001 / Advair Diskus Local Equivalence Study in Asthma
Status: Active, not recruiting Condition: Asthma

The Effect on Depressive Symptoms in ECF Residents With COPD
Status: Completed Condition: Chronic Obstructive Pulmonary Disease; Depression

Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

Atlantis Symbicort
Status: Completed Condition: Asthma

Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation
Status: Completed Condition: COPD; Chronic Obstructive Pulmonary Disease

Comparing Fluticasone-Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Status: Not yet recruiting Condition: COPD

Dose-Response of Salmeterol in Children
Status: Completed Condition: Asthma

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
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes7,107,986*PED<disabled>Y<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-002Jun 8, 2006RXYes6,315,173*PED<disabled>Y<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes6,431,168*PED<disabled>Y<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes6,743,413*PED<disabled>Y<disabled>
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 2006RXYes6,315,173*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: ADVAIR HFA

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
6,303,103 Aerosols containing salmeterol xinafoate and an anticholinergic medicament<disabled in preview>
5,683,676 Canister containing aerosol formulations containing P134a and particulate medicaments<disabled in preview>
5,676,929 Canister containing aerosol formulations containing P134a and particulate medicaments<disabled in preview>
7,101,534Suspension aerosol formulations<disabled in preview>
5,736,124 Aerosol formulations containing P134a and particulate medicament<disabled in preview>
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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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