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Details for Generic Name: formoterol fumarate; mometasone furoate

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Formoterol fumarate; mometasone furoate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are sixteen drug master file entries for formoterol fumarate; mometasone furoate. One supplier is listed for this compound.

Summary for Generic Name: formoterol fumarate; mometasone furoate

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list16
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details

Pharmacology for Ingredient: formoterol fumarate; mometasone furoate

Clinical Trials for: formoterol fumarate; mometasone furoate

Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
Status: Completed Condition: Asthma

A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
Status: Completed Condition: Asthma

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

Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers
Status: Completed Condition: Healthy

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)
Status: Completed Condition: Asthma

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)
Status: Completed Condition: Asthma

Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
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)

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3)
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;INHALATION022518-002Jun 22, 2010RXYes6,057,307*PED<disabled><disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010RXYes5,889,015*PED<disabled><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;INHALATION022518-001Jun 22, 2010RXYes7,067,502<disabled>Y<disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010RXYes7,566,705<disabled>Y<disabled>
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Non-Orange Book Patents for Generic Ingredient: formoterol fumarate; mometasone furoate

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>
5,837,699 Use of mometasone furoate for treating upper airway passage diseases<disabled in preview>
6,677,322 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>
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 Ingredient: formoterol fumarate; mometasone furoate

Country Document Number Publication Date
Denmark1156790Sep 29, 2003
Germany60003160Jul 10, 2003
New Zealand513742Sep 28, 2001
Canada2362499Jan 27, 2009
Hungary229073Jul 29, 2013
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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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