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Last Updated: July 6, 2020

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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-seven patent family members in twelve 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.

US ANDA Litigation and 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:27
US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for QBREXZA
DailyMed Link:QBREXZA at DailyMed
Drug patent expirations by year for QBREXZA
Drug Prices for QBREXZA

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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

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
>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 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 CR 2013 00015 Denmark   Start Trial PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Dow
Medtronic
Harvard Business School
Express Scripts

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 verification 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.