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
| International Patents: | 86 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Patent Applications: | 152 |
| Drug Prices: | Drug price information for ARCAPTA NEOHALER |
| DailyMed Link: | ARCAPTA NEOHALER at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ARCAPTA NEOHALER
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Slovakia | 17432001 | Agonisty beta-2-adrenoreceptorov, spôsob ich prípravy, ich použitie a farmaceutický prostriedok s ich obsahom (BETA2-ADRENOCEPTOR AGONISTS, PROCESS FOR THE PREPARATION AND USE THEREOF AND PHARMACEUTICAL COMPOSITION COMPRISING SAME) | ⤷ Sign Up |
| United Kingdom | 9913083 | ⤷ Sign Up | |
| Denmark | 2332915 | ⤷ Sign Up | |
| Peru | 02192001 | ⤷ Sign Up | |
| Mexico | PA06013081 | DISPOSITIVO INHALADOR. (INHALER DEVICE.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARCAPTA NEOHALER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1183240 | C01183240/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH |
| 1183240 | 91651 | Luxembourg | ⤷ Sign Up | 91651, EXPIRES: 20241130 |
| 1183240 | SZ 7/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON |
| 1183240 | C 2010 011 | Romania | ⤷ Sign Up | 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 | 10C0006 | France | ⤷ Sign Up | 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 |
| >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.
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