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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Chubb
Medtronic
Express Scripts
Merck
Citi
Teva
Cerilliant
Farmers Insurance

Generated: October 22, 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 NDA: 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 0085-4610-01 1 CANISTER in 1 CARTON (0085-4610-01) > 120 AEROSOL in 1 CANISTER
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION 022518 NDA Merck Sharp & Dohme Corp. 0085-4610 0085-4610-02 1 CANISTER in 1 CARTON (0085-4610-02) > 120 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 Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-001Jun 22, 2010► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
Queensland Health
Healthtrust
QuintilesIMS
Julphar
Express Scripts
Daiichi Sankyo
Fish and Richardson
Moodys

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