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Last Updated: March 29, 2024

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qbrexza Drug Patent Profile


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When do Qbrexza patents expire, and what generic alternatives are available?

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-four 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 Loss of Exclusivity (LOE) 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Topical glycopyrrolate formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Glycopyrrolate salts
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Glycopyrrolate salts
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Topical glycopyrrolate formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Crystalline glycopyrrolate tosylate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Glycopyrrolate salts
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Topical glycopyrrolate formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Journey QBREXZA glycopyrronium tosylate CLOTH;TOPICAL 210361-001 Jun 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 16269524
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 02795
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5026369
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 61734
Estimated Expiration: ⤷  Try a Trial

Patent: 73615
Estimated Expiration: ⤷  Try a Trial

Patent: 42419
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 12350
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0684
Estimated Expiration: ⤷  Try a Trial

Patent: 8152
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 14841
Estimated Expiration: ⤷  Try a Trial

Patent: 79246
Estimated Expiration: ⤷  Try a Trial

Patent: 16510037
Estimated Expiration: ⤷  Try a Trial

Patent: 17128593
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 15011228
Estimated Expiration: ⤷  Try a Trial

Patent: 20002544
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0740
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201506789P
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2232806
Estimated Expiration: ⤷  Try a Trial

Patent: 2377252
Estimated Expiration: ⤷  Try a Trial

Patent: 150119468
Estimated Expiration: ⤷  Try a Trial

Patent: 160081989
Estimated Expiration: ⤷  Try a Trial

Patent: 190138676
Estimated Expiration: ⤷  Try a Trial

Patent: 210034691
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 99257
Estimated Expiration: ⤷  Try a Trial

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
Hong Kong 1212350 格隆鈉鹽 (GLYCOPYRROLATE SALTS) ⤷  Try a Trial
Japan 6114841 ⤷  Try a Trial
Mexico 2015011228 SALES DE GLICOPIRROLATO. (GLYCOPYRROLATE SALTS.) ⤷  Try a Trial
South Korea 20160081989 글리코피롤레이트 염 (GLYCOPYRROLATE SALTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for qbrexza

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 15/2021 Austria ⤷  Try a Trial PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435025 300995 Netherlands ⤷  Try a Trial 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 16/2013 Austria ⤷  Try a Trial PRODUCT NAME: GLYCOPYRRONIUM, GLYCOPYRRONIUMSALZ; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 C300583 Netherlands ⤷  Try a Trial PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; 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.