Indacaterol maleate - Generic Drug Details
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What are the generic drug sources for indacaterol maleate and what is the scope of freedom to operate?
Indacaterol maleate
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Indacaterol maleate has eighty-six patent family members in thirty-nine countries.
Summary for indacaterol maleate
| International Patents: | 86 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Clinical Trials: | 24 |
| Patent Applications: | 384 |
| DailyMed Link: | indacaterol maleate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for indacaterol maleate
*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.
Recent Clinical Trials for indacaterol maleate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mundipharma Research Limited | Phase 2/Phase 3 |
| Novartis Pharmaceuticals | Phase 4 |
| Novartis Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for indacaterol maleate
US Patents and Regulatory Information for indacaterol maleate
| 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 | ⤷ Sign Up | |||
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | 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 indacaterol maleate
| 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 indacaterol maleate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1156451 | ⤷ Sign Up | |
| Norway | 2010014 | ⤷ Sign Up | |
| Norway | 334854 | ⤷ Sign Up | |
| 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 |
| Poland | 198847 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for indacaterol maleate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | CA 2014 00020 | Denmark | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919 |
| 1183240 | SZ 7/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON |
| 1183240 | SPC/GB10/009 | United Kingdom | ⤷ Sign Up | 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 | 383 | Finland | ⤷ Sign Up | |
| 1183240 | CA 2010 00006 | Denmark | ⤷ Sign Up | PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
