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
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 |
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.
Anatomical Therapeutic Chemical (ATC) Classes for ARCAPTA NEOHALER
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 |
|---|---|---|---|
| China | 1353692 | ⤷ Try a Trial | |
| European Patent Office | 1747036 | Dispositif d'inhalation (Inhaler device) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 0075114 | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 1183240 | 10C0006 | France | ⤷ Try a Trial | PRODUCT NAME: INDACATEROL OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/09/593/001 DU 20091130; REGISTRATION NO/DATE AT EEC: EU/1/09/593/001-010 DU 20091130 |
| 1267866 | 122014000025 | Germany | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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