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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 seventeen drug master file entries for formoterol fumarate; mometasone furoate. Two suppliers are 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 list17
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: 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, 2010RXYes6,068,832► subscribeY ► subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010RXYes7,566,705► subscribeY ► subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010RXYes7,566,705► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: formoterol fumarate; mometasone furoate

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, 20106,677,323► subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 20105,889,015*PED► subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 20105,889,015*PED► subscribe
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International Patent Family for Ingredient: formoterol fumarate; mometasone furoate

Country Document Number Estimated Expiration
Hungary229073► subscribe
Chile2004001170► subscribe
Hong Kong1043048► subscribe
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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► subscribePRODUCT 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► subscribePRODUCT 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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