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Last Updated: April 17, 2021

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QBREXZA Drug Profile

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Which patents cover Qbrexza, and when can generic versions of Qbrexza launch?

Qbrexza is a drug marketed by Dermira Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has twenty-nine patent family members in thirteen countries.

The generic ingredient in QBREXZA is glycopyrronium tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrronium tosylate profile page.

DrugPatentWatch® Generic Entry Outlook for Qbrexza

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for QBREXZA
International Patents:29
US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for QBREXZA
What excipients (inactive ingredients) are in QBREXZA?QBREXZA excipients list
DailyMed Link:QBREXZA at DailyMed
Drug patent expirations by year for QBREXZA
Drug Prices for QBREXZA

See drug prices for QBREXZA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for QBREXZA
Generic Entry Date for QBREXZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CLOTH;TOPICAL

*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 QBREXZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dr. August Wolff GmbH & Co. KG ArzneimittelPhase 2
Therapeutics, Inc.Phase 2

See all QBREXZA clinical trials

Pharmacology for QBREXZA
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Paragraph IV (Patent) Challenges for QBREXZA
Tradename Dosage Ingredient NDA Submissiondate
QBREXZA CLOTH;TOPICAL glycopyrronium tosylate 210361 2020-01-13

US Patents and Regulatory Information for QBREXZA

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 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   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 QBREXZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 92166 Luxembourg   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
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 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 2013/014 Ireland   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 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

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