ARCAPTA NEOHALER Drug Patent Profile

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

Summary for ARCAPTA NEOHALER

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Patent Applications:	190
Drug Prices:	Drug price information for ARCAPTA NEOHALER
DailyMed Link:	ARCAPTA NEOHALER at DailyMed

See drug prices for ARCAPTA NEOHALER

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

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.

Anatomical Therapeutic Chemical (ATC) Classes for ARCAPTA NEOHALER

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for ARCAPTA NEOHALER

ARCAPTA NEOHALER is protected by two US patents.

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

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			Y	Y
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No			Y

Expired US Patents for ARCAPTA NEOHALER

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

International Patents for ARCAPTA NEOHALER

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	20014301
Norway	322944
Portugal	2332915
Spain	2402535
Slovenia	1183240
New Zealand	550625	Inhaler device with capsule piercing means comprising a pair of opposed spring biased push buttons that each include at least one piercing element
Canada	2563573	DISPOSITIF D'INHALATION (INHALER DEVICE)

Supplementary Protection Certificates for ARCAPTA NEOHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1183240	C 2010 011	Romania		PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...]
1267866	CA 2014 00020	Denmark		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
1183240	383	Finland
1183240	SZ 7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1183240	C01183240/01	Switzerland		FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1183240	C300437	Netherlands		PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1267866	132014902244065	Italy		PRODUCT NAME: INDACATEROLO O UN SUO SALE, IN PARTICOLARE IL SALE MALEATO, E GLICOPIRRONIO O UN SUO SALE, IN PARTICOLARE IL SALE BROMURO, IN ASSOCIAZIONE(ULTIBRO BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/862, 20130919