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Profile for Tradename: NASONEX

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Nasonex is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NASONEX is mometasone furoate monohydrate. 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 monohydrate profile page.

Summary for Tradename: NASONEX

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
2013 Sales:$1,137,402,000

Pharmacology for Tradename: NASONEX

Clinical Trials for: NASONEX

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

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Status: Withdrawn Condition: Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography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 Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)
Status: Completed Condition: Rhinitis, Allergic, Perennial

Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Status: Completed Condition: Seasonal Allergic Rhinitis

Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)
Status: Completed Condition: Allergic Rhinitis

Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04208)
Status: Completed Condition: Allergic Rhinitis

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

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

A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures
Status: Completed Condition: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

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

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
NASONEX
mometasone furoate monohydrate
SPRAY, METERED;NASAL020762-001Oct 1, 1997RXYes6,723,713*PED<disabled><disabled>
Merck Sharp Dohme
NASONEX
mometasone furoate monohydrate
SPRAY, METERED;NASAL020762-001Oct 1, 1997RXYes6,127,353*PED<disabled>Y<disabled>
Merck Sharp Dohme
NASONEX
mometasone furoate monohydrate
SPRAY, METERED;NASAL020762-001Oct 1, 1997RXYes5,837,699*PED<disabled><disabled>
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Paragraph IV activity for: NASONEX

Drugname Dosage Strength RLD Submissiondate
mometasone furoateNasal Spray50 mcg/ SprayNasonex8/7/2009

Non-Orange Book Patents for Tradename: NASONEX

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
6,949,532 Use of mometasone furoate for treating airway passage and lung diseases<disabled in preview>
5,889,015 Use of mometasone furoate for treating lower airway passage and lung diseases<disabled in preview>
6,956,030 Use of mometasone furoate for treating upper airway diseases<disabled in preview>
6,365,581 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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