Indacaterol maleate - Generic Drug Details
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What are the generic 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: | 39 |
| Clinical Trials: | 24 |
| Patent Applications: | 478 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for indacaterol maleate |
| DailyMed Link: | indacaterol maleate at DailyMed |
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 |
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | See Plans and Pricing | See Plans and Pricing |
| Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for indacaterol maleate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 9913083 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 0075114 | See Plans and Pricing | |
| Taiwan | 200613021 | Organic compounds | See Plans and Pricing |
| Poland | 352100 | See Plans and Pricing | |
| Israel | 146578 | BETA 2 ADRENOCEPTOR AGONISTS | See Plans and Pricing |
| Turkey | 200103497 | See Plans and Pricing | |
| Colombia | 5170518 | COMPUESTOS N-(BENZOCICLOALQUILO) DERIVADOS DE AMINO ARALIFATICOS | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for indacaterol maleate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | 122014000025 | Germany | See Plans and Pricing | 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 |
| 1183240 | SPC/GB10/009 | United Kingdom | See Plans and Pricing | 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 | CA 2010 00006 | Denmark | See Plans and Pricing | PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT |
| 1267866 | 132014902244065 | Italy | See Plans and Pricing | 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 |
| 1183240 | SPC009/2010 | Ireland | See Plans and Pricing | SPC009/2010: 20100813, EXPIRES: 20241129 |
| 1183240 | 7/2010 | Austria | See Plans and Pricing | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
| 1267866 | 92393 | Luxembourg | See Plans and Pricing | 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 |
