ARCAPTA NEOHALER Drug Patent Profile

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When do Arcapta Neohaler patents expire, and what generic alternatives are available?

Arcapta Neohaler is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

This drug has eighty-six patent family members in thirty-nine countries.

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. Additional details are available on the indacaterol maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Arcapta Neohaler

Arcapta Neohaler was eligible for patent challenges on July 1, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 11, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ARCAPTA NEOHALER

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Patent Applications:	152
Drug Prices:	Drug price information for ARCAPTA NEOHALER
DailyMed Link:	ARCAPTA NEOHALER at DailyMed

Drug patent expirations by year for ARCAPTA NEOHALER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ARCAPTA NEOHALER

Generic Entry Date for ARCAPTA NEOHALER^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 022383 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.

US Patents and Regulatory Information for ARCAPTA NEOHALER

ARCAPTA NEOHALER is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARCAPTA NEOHALER is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ARCAPTA NEOHALER

Beta2-adrenoceptor agonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Inhaler device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ARCAPTA NEOHALER

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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

International Patents for ARCAPTA NEOHALER

See the table below for patents covering ARCAPTA NEOHALER around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2012071146	INHALER	⤷ Sign Up
China	1156451		⤷ Sign Up
Slovakia	17432001	Agonisty beta-2-adrenoreceptorov, spôsob ich prípravy, ich použitie a farmaceutický prostriedok s ich obsahom (BETA2-ADRENOCEPTOR AGONISTS, PROCESS FOR THE PREPARATION AND USE THEREOF AND PHARMACEUTICAL COMPOSITION COMPRISING SAME)	⤷ Sign Up
China	1353692		⤷ Sign Up
Germany	602005027064		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ARCAPTA NEOHALER

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	CA 2014 00020	Denmark	⤷ Sign Up	PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919
1267866	92393	Luxembourg	⤷ Sign Up	PRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923
1267866	122014000025	Germany	⤷ Sign Up	PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919
1183240	383	Finland	⤷ Sign Up
1183240	SPC009/2010	Ireland	⤷ Sign Up	SPC009/2010: 20100813, EXPIRES: 20241129
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description