Glycopyrrolate; indacaterol maleate - Generic Drug Details
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What are the generic sources for glycopyrrolate; indacaterol maleate and what is the scope of patent protection?
Glycopyrrolate; indacaterol maleate
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Glycopyrrolate; indacaterol maleate has one hundred and forty-eight patent family members in forty countries.
Summary for glycopyrrolate; indacaterol maleate
| International Patents: | 148 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | glycopyrrolate; indacaterol maleate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for glycopyrrolate; indacaterol maleate
Generic Entry Date for glycopyrrolate; 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.
Anatomical Therapeutic Chemical (ATC) Classes for glycopyrrolate; indacaterol maleate
US Patents and Regulatory Information for glycopyrrolate; 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 | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 glycopyrrolate; indacaterol maleate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for glycopyrrolate; indacaterol maleate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 322944 | ⤷ Try a Trial | |
| Germany | 60042781 | ⤷ Try a Trial | |
| Portugal | 1747036 | ⤷ Try a Trial | |
| European Patent Office | 1670438 | COMPOSITION POUDREUSE SECHE POUR INHALATION PULMONAIRE,COMPRENANT UNE BENDIAZEPINE (DRY POWDER COMPOSITION COMPRISING A BENZODIAZEPINE FOR PULMONARY INHALATION) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for glycopyrrolate; indacaterol maleate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1183240 | 10C0006 | France | ⤷ Try a Trial | 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 |
| 1183240 | SPC009/2010 | Ireland | ⤷ Try a Trial | SPC009/2010: 20100813, EXPIRES: 20241129 |
| 1183240 | 7/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
| 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 |
