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Last Updated: October 1, 2022

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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Drug patent expirations by year for ARCAPTA NEOHALER
Drug Prices for ARCAPTA NEOHALER

See drug prices for ARCAPTA NEOHALER

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ARCAPTA NEOHALER
Generic Entry Date for ARCAPTA NEOHALER*:
Constraining patent/regulatory exclusivity:
NDA:
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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

International Patents for ARCAPTA NEOHALER

When does loss-of-exclusivity occur for ARCAPTA NEOHALER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1353
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05245095
Estimated Expiration: See Plans and Pricing

Austria

Patent: 2666
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0511073
Estimated Expiration: See Plans and Pricing

Canada

Patent: 63573
Estimated Expiration: See Plans and Pricing

China

Patent: 53779
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11555
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 47036
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066987
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 47036
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2005027064
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 02919
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8878
Estimated Expiration: See Plans and Pricing

Japan

Patent: 14345
Estimated Expiration: See Plans and Pricing

Patent: 07536962
Estimated Expiration: See Plans and Pricing

Patent: 12071146
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4563
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06013081
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 612
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0625
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4854
Estimated Expiration: See Plans and Pricing

Patent: 065718
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060098
Estimated Expiration: See Plans and Pricing

Poland

Patent: 47036
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 47036
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 63501
Estimated Expiration: See Plans and Pricing

Patent: 06143840
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 47036
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0608728
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1170187
Estimated Expiration: See Plans and Pricing

Patent: 070011466
Estimated Expiration: See Plans and Pricing

Spain

Patent: 62429
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 53857
Estimated Expiration: See Plans and Pricing

Patent: 0613021
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 06367
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 10712
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Ecuador SP066987 DISPOSITIVO INHALADOR See Plans and Pricing
Austria 440083 See Plans and Pricing
Taiwan I353857 See Plans and Pricing
Taiwan 200613021 Organic compounds See Plans and Pricing
Denmark 1747036 See Plans and Pricing
Japan 4914345 See Plans and Pricing
Israel 146578 BETA 2 ADRENOCEPTOR AGONISTS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARCAPTA NEOHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1183240 CA 2010 00006 Denmark See Plans and Pricing PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT
1183240 C01183240/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1267866 92393 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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 SPC/GB10/009 United Kingdom See Plans and Pricing PRODUCT NAME: INDACATEROL OR A SALT THEREOF; REGISTERED: UK EU/1/09/593/001 20091130; UK EU/1/09/593/002 20091130; UK EU/1/09/593/003 20091130; UK EU/1/09/593/004 20091130; UK EU/1/09/593/005 20091130; UK EU/1/09/593/006 20091130; UK EU/1/09/593/007 20091130; UK EU/1/09/593/008 20091130; UK EU/1/09/593/009 20091130; UK EU/1/09/593/010 20091130
1183240 SZ 7/2010 Austria See Plans and Pricing PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1183240 C300437 Netherlands See Plans and Pricing PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKinsey
Colorcon
Boehringer Ingelheim
McKesson
AstraZeneca

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.