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 is one patent protecting this drug.
The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. There is one drug master file entry for this compound. 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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Questions you can ask:
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Summary for ARCAPTA NEOHALER
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Patent Applications: | 295 |
| 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.
US Patents and Regulatory Information for ARCAPTA NEOHALER
ARCAPTA NEOHALER is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARCAPTA NEOHALER is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start 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.
| 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 | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start 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 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Start Trial | ⤷ Start Trial |
| >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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 035548 | COMPUESTOS ORGANICOS | ⤷ Start Trial |
| Austria | 440083 | ⤷ Start Trial | |
| Australia | 5074500 | ⤷ Start Trial | |
| Australia | 765919 | ⤷ Start 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 | C300437 | Netherlands | ⤷ Start Trial | PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
| 1183240 | CA 2010 00006 | Denmark | ⤷ Start Trial | PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT |
| 1183240 | 91651 | Luxembourg | ⤷ Start Trial | 91651, EXPIRES: 20241130 |
| 1183240 | SPC009/2010 | Ireland | ⤷ Start Trial | SPC009/2010: 20100813, EXPIRES: 20241129 |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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