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Last Updated: May 26, 2022

QBREXZA Drug Patent Profile


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

Qbrexza is a drug marketed by Journey and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two 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.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for QBREXZA
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
Therapeutics, Inc.Phase 2
Dr. August Wolff GmbH & Co. KG ArzneimittelPhase 2
University of UtahPhase 2

See all QBREXZA clinical trials

Paragraph IV (Patent) Challenges for QBREXZA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QBREXZA Topical Cloth glycopyrronium tosylate 2.4% 210361 1 2020-01-13

US Patents and Regulatory Information for QBREXZA

QBREXZA is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QBREXZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QBREXZA

Glycopyrrolate salts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Topical glycopyrrolate formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Glycopyrrolate salts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Glycopyrrolate salts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Topical glycopyrrolate formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Crystalline glycopyrrolate tosylate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Glycopyrrolate salts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Topical glycopyrrolate formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for QBREXZA

When does loss-of-exclusivity occur for QBREXZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14223172
Estimated Expiration: See Plans and Pricing

Patent: 16269524
Estimated Expiration: See Plans and Pricing

Canada

Patent: 02795
Estimated Expiration: See Plans and Pricing

China

Patent: 5026369
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 61734
Estimated Expiration: See Plans and Pricing

Patent: 73615
Estimated Expiration: See Plans and Pricing

Patent: 42419
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 12350
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0684
Estimated Expiration: See Plans and Pricing

Patent: 8152
Estimated Expiration: See Plans and Pricing

Japan

Patent: 14841
Estimated Expiration: See Plans and Pricing

Patent: 79246
Estimated Expiration: See Plans and Pricing

Patent: 16510037
Estimated Expiration: See Plans and Pricing

Patent: 17128593
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 15011228
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0740
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201506789P
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2232806
Estimated Expiration: See Plans and Pricing

Patent: 150119468
Estimated Expiration: See Plans and Pricing

Patent: 160081989
Estimated Expiration: See Plans and Pricing

Patent: 190138676
Estimated Expiration: See Plans and Pricing

Patent: 210034691
Estimated Expiration: See Plans and Pricing

Spain

Patent: 99257
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QBREXZA around the world.

Country Patent Number Title Estimated Expiration
Mexico 2015011228 SALES DE GLICOPIRROLATO. (GLYCOPYRROLATE SALTS.) See Plans and Pricing
Japan 2016510037 グリコピロレート塩 See Plans and Pricing
South Korea 20210034691 글리코피롤레이트 염 (GLYCOPYRROLATE SALTS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QBREXZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 92393 Luxembourg See Plans and Pricing 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
2435025 300995 Netherlands See Plans and Pricing PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220
1267866 2013/014 Ireland See Plans and Pricing PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.