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Generated: May 29, 2017

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 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 NDA: 022383


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
indacaterol maleate
POWDER;INHALATION 022383 NDA Novartis Pharmaceuticals Corporation 0078-0619 0078-0619-06 6 CAPSULE in 1 BOX, UNIT-DOSE (0078-0619-06)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 75MCG BASE
Approval Date:Jul 1, 2011TE:RLD:Yes
Patent:8,479,730Patent Expiration:Oct 11, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:8,796,307Patent Expiration:Jun 2, 2020Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jul 1, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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