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Last Updated: April 24, 2024

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

See drug prices for ARCAPTA NEOHALER

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 ⤷  Try a Trial ⤷  Try a Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Australia

Patent: 05245095
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 02666
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0511073
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 63573
Estimated Expiration: ⤷  Try a Trial

China

Patent: 53779
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11555
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 066987
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005027064
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 02919
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8878
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 14345
Estimated Expiration: ⤷  Try a Trial

Patent: 07536962
Estimated Expiration: ⤷  Try a Trial

Patent: 12071146
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4563
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06013081
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 612
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0625
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 4854
Estimated Expiration: ⤷  Try a Trial

Patent: 065718
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060098
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 63501
Estimated Expiration: ⤷  Try a Trial

Patent: 06143840
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0608728
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1170187
Estimated Expiration: ⤷  Try a Trial

Patent: 070011466
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 62429
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 53857
Estimated Expiration: ⤷  Try a Trial

Patent: 0613021
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 06367
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 10712
Estimated Expiration: ⤷  Try a Trial

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
Portugal 2332915 ⤷  Try a Trial
Ecuador SP066987 DISPOSITIVO INHALADOR ⤷  Try a Trial
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 ⤷  Try a Trial
Spain 2402535 ⤷  Try a Trial
South Korea 101170187 ⤷  Try a Trial
Cyprus 1114120 ⤷  Try a Trial
South Africa 200109931 Beta2-adrenoceptor agonists. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARCAPTA NEOHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1183240 7/2010 Austria ⤷  Try a Trial PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240 C01183240/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1183240 C 2010 011 Romania ⤷  Try a Trial 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 [...]
1183240 CA 2010 00006 Denmark ⤷  Try a Trial PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT
1183240 SPC009/2010 Ireland ⤷  Try a Trial SPC009/2010: 20100813, EXPIRES: 20241129
1267866 132014902244065 Italy ⤷  Try a Trial 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
1267866 92393 Luxembourg ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.