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Last Updated: December 16, 2019

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 two suppliers. There are two 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 nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.
Summary for 022518
Tradename:DULERA
Applicant:Merck Sharp Dohme
Ingredient:formoterol fumarate; mometasone furoate
Patents:2
Generic Entry Opportunity Date for 022518
Generic Entry Date for 022518*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS
Dosage:
AEROSOL, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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. 0085-2223 0085-2223-01 1 CANISTER in 1 CARTON (0085-2223-01) > 120 AEROSOL in 1 CANISTER
DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518 NDA Merck Sharp & Dohme Corp. 0085-2223 0085-2223-02 1 CANISTER in 1 CARTON (0085-2223-02) > 120 AEROSOL in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.005MG/INH;0.1MG/INH
Approval Date:Jun 22, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 20, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS
Regulatory Exclusivity Expiration:Jun 20, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:  Start TrialPatent Expiration:Nov 21, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022518

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010   Start Trial   Start Trial
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010   Start Trial   Start Trial
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010   Start Trial   Start Trial
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010   Start Trial   Start Trial
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010   Start Trial   Start Trial
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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