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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 five 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:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list8
Formulation / Manufacturing:see details

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Status: Withdrawn Condition: Asthma

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

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma
Status: Enrolling by invitation 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, 2010RXYes7,067,502<disabled>Y<disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010RXYes6,057,307*PED<disabled><disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010RXYes7,566,705<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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Non-Orange Book Patents for Tradename: DULERA

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>
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>
6,956,030 Use of mometasone furoate for treating upper airway diseases<disabled in preview>
6,677,323 Use of mometasone furoate for treating airway passage and lung diseases<disabled in preview>
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International Patent Family for Tradename: DULERA

Country Document Number Publication Date
South Africa200106442Sep 05, 2002
Japan2010001295Jan 07, 2010
Japan5646828Dec 24, 2014
European Patent Office1156790Jun 04, 2003
Canada2362499Jan 27, 2009
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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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