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Last Updated: March 6, 2021

DrugPatentWatch Database Preview

Glycopyrronium tosylate - Generic Drug Details

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What are the generic drug sources for glycopyrronium tosylate and what is the scope of freedom to operate?

Glycopyrronium tosylate is the generic ingredient in one branded drug marketed by Dermira Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glycopyrronium tosylate has twenty-nine patent family members in thirteen countries.

There is one drug master file entry for glycopyrronium tosylate. One supplier is listed for this compound.

Summary for glycopyrronium tosylate
International Patents:29
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
DailyMed Link:glycopyrronium tosylate at DailyMed
Pharmacology for glycopyrronium tosylate
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Paragraph IV (Patent) Challenges for GLYCOPYRRONIUM TOSYLATE
Tradename Dosage Ingredient NDA Submissiondate
QBREXZA CLOTH;TOPICAL glycopyrronium tosylate 210361 2020-01-13

US Patents and Regulatory Information for glycopyrronium tosylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Dermira Inc QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 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

Supplementary Protection Certificates for glycopyrronium tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 C300583 Netherlands   Start Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 92393 Luxembourg   Start Trial 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
1267866 16/2013 Austria   Start Trial PRODUCT NAME: GLYCOPYRRONIUM, GLYCOPYRRONIUMSALZ; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 2013/014 Ireland   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 122014000025 Germany   Start 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
1267866 SPC/GB13/020 United Kingdom   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928
1267866 2013C/023 Belgium   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/788/001 20121002
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Moodys
Merck
Harvard Business School
Baxter
Express Scripts

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