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Formoterol fumarate; mometasone furoate - Generic Drug Details

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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 three 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:3
Applicants:1
NDAs:1
Drug Master File Entries: see list16
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: formoterol fumarate; mometasone furoate

Clinical Trials for: formoterol fumarate; mometasone furoate

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, 2010RXYes7,067,502<disabled>Y <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;INHALATION022518-002Jun 22, 2010RXYes7,566,705<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: formoterol fumarate; mometasone furoate

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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, 20106,057,307*PED<disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 20106,677,323<disabled>
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 20106,677,323<disabled>
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International Patent Family for Ingredient: formoterol fumarate; mometasone furoate

Country Document Number Estimated Expiration
China1196478<disabled in preview>
Norway20013988<disabled in preview>
China1341017<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FORMOTEROL FUMARATE; MOMETASONE FUROATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
02C/022Belgium<disabled>PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
C/GB02/033United Kingdom<disabled>PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
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