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Profile for Tradename: ASMANEX HFA

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Asmanex Hfa is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are four patents protecting this drug.

The generic ingredient in ASMANEX HFA is mometasone furoate. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for Tradename: ASMANEX HFA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list4

Pharmacology for Tradename: ASMANEX HFA

Clinical Trials for: ASMANEX HFA

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)
Status: Completed Condition: Rhinitis, Allergic, Perennial

Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
Status: Completed Condition: Asthma

Acute Effect of Mometasone on Beta-adrenergic Airway and Airway Vascular Relaxation in Severe Asthma
Status: Completed Condition: Asthma

Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Status: Withdrawn Condition: Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography

A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)
Status: Completed Condition: Perennial Allergic Rhinitis

Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)
Status: Completed Condition: Asthma; Airway Inflammation

Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)
Status: Terminated Condition: Nasal Obstruction; Adenoids Hypertrophy; Adenoidectomy

Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis
Status: Completed Condition: Perennial Allergic Rhinitis

An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma
Status: Completed Condition: Allergic Rhinitis; Asthma

Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED)
Status: Terminated 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
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-001Apr 25, 2014RXNo6,068,832<disabled>Y<disabled>
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-002Apr 25, 2014RXYes6,365,581*PED<disabled><disabled>
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-001Apr 25, 2014RXNo6,365,581*PED<disabled><disabled>
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-002Apr 25, 2014RXYes5,889,015*PED<disabled><disabled>
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-001Apr 25, 2014RXNo5,889,015*PED<disabled><disabled>
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Non-Orange Book Patents for Tradename: ASMANEX 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
6,723,713 Use of mometasone furoate for treating upper airway diseases<disabled in preview>
5,837,699 Use of mometasone furoate for treating upper airway passage diseases<disabled in preview>
6,949,532 Use of mometasone furoate for treating airway passage and lung diseases<disabled in preview>
6,677,323 Use of mometasone furoate for treating airway passage and lung diseases<disabled in preview>
6,677,322 Use of mometasone furoate for treating airway passage and lung diseases<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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