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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022518

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NDA 022518 describes DULERA, which 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. Additional details are available on the DULERA profile page.

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are seventeen 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 022518

Tradename:1
Applicant:1
Ingredient:1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 022518

Suppliers and Packaging for NDA: 022518

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518 NDA Merck Sharp & Dohme Corp. 0085-4610 0085-4610-06 1 CANISTER in 1 CARTON (0085-4610-06) > 60 AEROSOL in 1 CANISTER
DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518 NDA Merck Sharp & Dohme Corp. 0085-4610 0085-4610-05 1 CANISTER in 1 CARTON (0085-4610-05) > 60 AEROSOL in 1 CANISTER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.005MG/INH;0.1MG/INH
Approval Date:Jun 22, 2010TE:RLD:Yes
Patent:► SubscribePatent Expiration:Aug 27, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA
Patent:► SubscribePatent Expiration:May 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA
Patent:► SubscribePatent Expiration:May 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA

Expired Orange Book Patents for NDA: 022518

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
Merck Sharp DohmeDULERAformoterol fumarate; mometasone furoateAEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
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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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