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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 022383


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NDA 022383 describes ARCAPTA NEOHALER, which is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ARCAPTA NEOHALER profile page.

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. Additional details are available on the indacaterol maleate profile page.
Summary for 022383
Tradename:ARCAPTA NEOHALER
Applicant:Novartis
Ingredient:indacaterol maleate
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage: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:Oct 11, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022383

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 ⤷  Sign Up ⤷  Sign Up
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 ⤷  Sign Up ⤷  Sign Up
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.