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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Boehringer Ingelheim
Healthtrust
UBS
Cerilliant
McKesson
Mallinckrodt
Chubb

Generated: May 24, 2018

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 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 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:DULERA
Applicant:Merck Sharp Dohme
Ingredient:formoterol fumarate; mometasone furoate
Patents:2
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 N 0085-4610-01
DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518 NDA Merck Sharp & Dohme Corp. 0085-4610 N 0085-4610-02

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
Patent:➤ Sign UpPatent Expiration:May 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA
Patent:➤ Sign UpPatent Expiration:May 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA

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

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Baxter
Deloitte
Healthtrust
Dow
Medtronic
Teva
Mallinckrodt
Farmers Insurance

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