Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

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 freedom to operate?

Glycopyrrolate ; indacaterol maleate is the generic ingredient in one branded drug marketed by Sunovion Pharms Inc and is included in one NDA. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate ; indacaterol maleate has three hundred and seventy-four patent family members in forty-four countries.

There are seventeen drug master file entries for glycopyrrolate ; indacaterol maleate. One supplier is listed for this compound.

Summary for glycopyrrolate ; indacaterol maleate
Recent Litigation for glycopyrrolate ; indacaterol maleate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Vectura Limited v. GlaxoSmithKline LLC2016-07-27
Novartis AG v. Lee2013-01-14
NOVARTIS AG v. KAPPOS2010-07-06

See all glycopyrrolate ; indacaterol maleate litigation

Pharmacology 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
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start 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
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for glycopyrrolate ; indacaterol maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 2014C/022 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), AUTRE, ADRESSE (NO SUPPRIME)
1267866 122013000029 Germany   Start Trial PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 CA 2013 00015 Denmark   Start Trial
1267866 92166 Luxembourg   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
1267866 C300583 Netherlands   Start Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1183240 C 2010 011 Romania   Start 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 [...]
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
AstraZeneca
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.