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: | 43 |
| Clinical Trials: | 24 |
| Patent Applications: | 384 |
| DailyMed Link: | indacaterol maleate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for indacaterol maleate
Generic Entry Date for indacaterol maleate*:
Constraining patent/regulatory exclusivity:
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.
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 | ⤷ 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 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 | ⤷ 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 indacaterol maleate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 352100 | ⤷ Try a Trial | |
| Cyprus | 1111555 | ⤷ Try a Trial | |
| Hong Kong | 1045837 | ⤷ Try a Trial | |
| Portugal | 1747036 | ⤷ Try a Trial | |
| United Kingdom | 0410712 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for indacaterol maleate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1183240 | C300437 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 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 |
| 1183240 | C 2010 011 | Romania | ⤷ Try a Trial | 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 [...] |
| 1267866 | 132014902244065 | Italy | ⤷ Try a Trial | 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 | SPC/GB10/009 | United Kingdom | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
