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-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
Summary for QBREXZA
International Patents: | 34 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 3 |
Drug Prices: | Drug price information for QBREXZA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QBREXZA |
What excipients (inactive ingredients) are in QBREXZA? | QBREXZA excipients list |
DailyMed Link: | QBREXZA at DailyMed |
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
Sponsor | Phase |
---|---|
Dr. August Wolff GmbH & Co. KG Arzneimittel | Phase 2 |
Therapeutics, Inc. | Phase 2 |
University of Utah | Phase 2 |
Pharmacology for QBREXZA
Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for QBREXZA
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 |
Expired US Patents for QBREXZA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Journey | QBREXZA | glycopyrronium tosylate | CLOTH;TOPICAL | 210361-001 | Jun 28, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
---|---|---|---|
Australia | 2014203072 | Topical glycopyrrolate formulations | ⤷ Try a Trial |
Australia | 2016269524 | Glycopyrrolate salts | ⤷ Try a Trial |
European Patent Office | 2200550 | FORMULATIONS TOPIQUES DE GLYCOPYRROLATE (TOPICAL GLYCOPYRROLATE FORMULATIONS) | ⤷ Try a Trial |
South Korea | 102232806 | ⤷ 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 |
---|---|---|---|---|
1267866 | CA 2014 00020 | Denmark | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919 |
1267866 | 16/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM, GLYCOPYRRONIUMSALZ; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
2435025 | 36/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |