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Generated: November 20, 2018

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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 one supplier. 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. One supplier is 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
Generic Entry Opportunity Date for 022383
Generic Entry Date for 022383*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: 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 Sunovion Pharmaceuticals Inc. 63402-675 63402-675-01 6 CAPSULE in 1 BLISTER PACK (63402-675-01)
ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383 NDA Sunovion Pharmaceuticals Inc. 63402-675 63402-675-02 6 CAPSULE in 1 BLISTER PACK (63402-675-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 75MCG BASE
Approval Date:Jul 1, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 25, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:THE LONG TERM, ONCE-DAILY MAINTENANCE BRONCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
Patent:➤ Sign UpPatent Expiration:Jun 2, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:THE LONG TERM, ONCE-DAILY MAINTENANCE BRONCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
Patent:➤ Sign UpPatent Expiration:Oct 11, 2028Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Daiichi Sankyo
Federal Trade Commission
Boehringer Ingelheim
Harvard Business School
Express Scripts
Argus Health
Queensland Health

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