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Profile for Tradename: DULERA

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

This drug has thirty-four patent family members in twenty-six countries.

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.

Summary for Tradename: DULERA

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list8

Clinical Trials for: DULERA

Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Status: Recruiting Condition: Asthma

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3)
Status: Recruiting Condition: Asthma

Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)
Status: Withdrawn Condition: Asthma

Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Status: Recruiting Condition: Asthma

Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
Status: Recruiting Condition: Asthma

Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
Status: Completed Condition: Asthma

Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease (COPD)

Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease (COPD)

Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Status: Recruiting 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
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010RXYes6,068,832<disabled>Y <disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010RXYes6,068,832<disabled>Y <disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010RXYes7,067,502<disabled>Y <disabled>
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Expired Patents for Tradename: DULERA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 20105,889,015*PED<disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 20106,057,307*PED<disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 20106,677,323<disabled>
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International Patent Family for Tradename: DULERA

Country Document Number Publication Date
Japan2013067668Apr 18, 2013
European Patent Office1325765Jul 09, 2003
Indonesia30171Nov 08, 2001
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
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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