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Serving leading biopharmaceutical companies globally:

Chubb
Argus Health
Farmers Insurance
Moodys
Fish and Richardson
Citi
Julphar
Cipla
Accenture
Mallinckrodt

Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022383

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NDA 022383 describes ARCAPTA NEOHALER, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the ARCAPTA NEOHALER profile page.

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. Two suppliers are listed for this compound. Additional details are available on the indacaterol maleate profile page.
Summary for 022383
Tradename:ARCAPTA NEOHALER
Applicant:Sunovion Pharms Inc
Ingredient:indacaterol maleate
Patents:5
Pharmacology for NDA: 022383
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 022383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383 NDA Novartis Pharmaceuticals Corporation 0078-0619 0078-0619-06 6 CAPSULE in 1 BOX, UNIT-DOSE (0078-0619-06)
ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383 NDA Novartis Pharmaceuticals Corporation 0078-0619 0078-0619-15 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0619-15) > 1 CAPSULE in 1 BLISTER PACK (0078-0619-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 75MCG BASE
Approval Date:Jul 1, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 1, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ SubscribePatent Expiration:Feb 25, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
Patent:➤ SubscribePatent Expiration:Jun 2, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA

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Serving leading biopharmaceutical companies globally:

Novartis
Medtronic
Teva
Chubb
QuintilesIMS
Federal Trade Commission
Johnson and Johnson
Baxter
Chinese Patent Office

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