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Profile for Tradename: Singulair

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Singulair is a drug marketed by Merck and is included in three NDAs. It is available from eleven suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-five patent family members in twenty-five countries.

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for Tradename: Singulair

Suppliers / Packagers: see list41

Pharmacology for Tradename: Singulair

Clinical Trials for: Singulair

The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity
Status: Completed Condition: Cough; Bronchial Hyperreactivity

The Effect of Montelukast Treatment in Wheezy Infants
Status: Completed Condition: Lung Disease, Obstructive; Signs and Symptoms, Respiratory

Genotype Stratified Pharmacokinetic Study of Montelukast
Status: Recruiting Condition: Asthma

Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma
Status: Recruiting Condition: Asthma

Montelukast in Very Low Birthweight Infants
Status: Completed Condition: Bronchopulmonary Dysplasia

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
Status: Completed Condition: Asthma

A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
Status: Terminated Condition: Eosinophilic Esophagitis

A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)
Status: Completed Condition: Healthy

The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)(COMPLETED)
Status: Completed Condition: Asthma

The Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Status: Completed Condition: Atopic Dermatitis

Courtesy of
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
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002RXYes8,007,830<disabled>Y <disabled>
montelukast sodium
TABLET, CHEWABLE;ORAL020830-001Feb 20, 1998RXYes<disabled><disabled>
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002RXYes<disabled><disabled>
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Paragraph IV activity for: SINGULAIR

Drugname Dosage Strength RLD Submissiondate
montelukastTablets10 mgSingulair2/20/2007
montelukast sodiumChewable Tablets4 mg and 5 mgSingulair12/26/2006

International Patent Family for Tradename: SINGULAIR

Country Document Number Publication Date
Slovenia1441701Aug 31, 2008
Germany60225040Feb 26, 2009
China1575163Feb 02, 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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