GLYCOPYRROLATE; INDACATEROL MALEATE - Generic Drug Details
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What are the generic drug sources for glycopyrrolate; indacaterol maleate and what is the scope of freedom to operate?
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.
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 | 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 | |||
>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 |
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 |
---|---|---|---|
China | 1156451 | ⤷ Try a Trial | |
Australia | 5074500 | ⤷ Try a Trial | |
Spain | 2377205 | ⤷ Try a Trial | |
Canada | 2522231 | COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'APOMORPHINE POUR L'INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS COMPRISING APOMORPHINE FOR PULMONARY INHALATION) | ⤷ Try a Trial |
Peru | 20060098 | DISPOSITIVO INHALADOR | ⤷ 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 | 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 | 91651 | Luxembourg | ⤷ Try a Trial | 91651, EXPIRES: 20241130 |
1183240 | C300437 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
1183240 | C01183240/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH |
1183240 | 383 | Finland | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |