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QBREXZA Drug Patent Profile

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

See drug prices for QBREXZA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QBREXZA

NDA:

210361

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

See all QBREXZA clinical trials

Pharmacology for QBREXZA

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

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.

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

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			Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes			Y	Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes			Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes			Y

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

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

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Singapore

South Korea

Spain

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
Canada	2902795	SELS DE GLYCOPYRROLATE (GLYCOPYRROLATE SALTS)
South Korea	20150119468	글리코피롤레이트 염 (GLYCOPYRROLATE SALTS)
Canada	2702830	FORMULATIONS TOPIQUES DE GLYCOPYRROLATE (TOPICAL GLYCOPYRROLATE FORMULATIONS)
European Patent Office	2961734	SELS DE GLYCOPYRROLATE (GLYCOPYRROLATE SALTS)

Supplementary Protection Certificates for QBREXZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	2013/014	Ireland		PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
2435025	300995	Netherlands		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	2013C/023	Belgium		PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/788/001 20121002
1267866	SPC/GB13/020	United Kingdom		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