QBREXZA Drug Patent Profile

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-seven 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 three 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:	37
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	3
Patent Applications:	52
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.

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
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
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
Israel	278152	מלחי גליקופירולאט (Glycopyrrolate salts)
Japan	2016510037	グリコピロレート塩
European Patent Office	3473615
Mexico	2015011228	SALES DE GLICOPIRROLATO. (GLYCOPYRROLATE SALTS.)
Mexico	2020002544	SALES DE GLICOPIRROLATO. (GLYCOPYRROLATE SALTS.)
European Patent Office	3473615
Mexico	2010004262	FORMULACIONES TOPICAS DE GLICOPIRROLATO. (TOPICAL GLYCOPYRROLATE FORMULATIONS.)

Supplementary Protection Certificates for QBREXZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1267866	CA 2014 00020	Denmark		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	92393	Luxembourg		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
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
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
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
1267866	16/2013	Austria		PRODUCT NAME: GLYCOPYRRONIUM, GLYCOPYRRONIUMSALZ; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928

Market Dynamics and Financial Trajectory for QBREXZA

Last updated: July 27, 2025

Introduction

QBREXZA (glycopyrronium chloride) topical cloth, developed by Cantargia and marketed by Dermira (a division of Eli Lilly), represents a novel treatment for primary axillary hyperhidrosis—the condition characterized by excessive sweating in the underarms. Since its FDA approval in 2018, QBREXZA has navigated an evolving landscape of market demands, competitive pressures, and regulatory considerations. Understanding its market dynamics and financial trajectory requires an analysis of its clinical positioning, competitive environment, regulatory pathways, and commercial prospects.

Market Overview

Prevalence and Market Demand

Primary axillary hyperhidrosis affects approximately 3% of the global population, with higher prevalence among adults aged 25-64 [1]. This condition significantly impairs quality of life, leading to social stigma, emotional distress, and occupational challenges. The substantial patient unmet need has stimulated demand for effective, minimally invasive therapies.

Therapeutic Landscape

QBREXZA stands out as the first topical agent approved explicitly for hyperhidrosis, providing a non-invasive alternative to botulinum toxin injections and invasive surgical procedures. Prior to its approval, the mainstays included antiperspirants with aluminum chloride formulations and invasive interventions. The market is characterized by:

• Limited pharmacological options: primarily topical antiperspirants, with variable efficacy.
• Invasive procedures: Botox (onabotulinumtoxinA) injections, which, while effective, pose logistical and cost challenges.

The approval of QBREXZA introduced a paradigm shift, offering a convenient, topical solution with proven efficacy.

Market Penetration and Adoption

Initial Commercial Performance

Post-launch, QBREXZA experienced moderate adoption due to:

• Prescriber unfamiliarity
• Concerns over local side effects (e.g., dry skin, irritation)
• Reimbursement hurdles
• Limited awareness among both physicians and patients

However, early momentum was bolstered by strategic endocrinology and dermatology outreach, supported by the growing demand for patient-friendly hyperhidrosis treatments.

Market Expansion Strategies

Eli Lilly’s efforts to broaden access have centered on:

• Education campaigns emphasizing safety and quality of life benefits
• Ensuring reimbursement coverage
• Expanding clinician awareness through key opinion leader engagement

Competitive Pressures

While QBREXZA remains the primary topical therapy, competition includes:

• Botulinum toxin injections: high efficacy but invasive and costly.
• Off-label antiperspirants and compounded formulations: low cost but variable results.
• Emerging therapies: investigational systemic and minimally invasive devices are in early stages.

The market’s growth trajectory hinges on overcoming barriers to adoption and establishing clear clinical advantages over existing therapies.

Regulatory and Reimbursement Landscape

Regulatory Developments

Continued regulatory focus centers on safety; post-marketing studies have monitored adverse events, ensuring compliance with evolving standards. No significant regulatory hurdles currently threaten QBREXZA’s market presence.

Reimbursement Environment

Reimbursement policies influence market growth. In the U.S., Medicare and private insurers have progressively incorporated QBREXZA coverage, contingent on coding and prior authorization procedures. Price negotiations and formulary placements impact sales volume.

Financial Trajectory and Market Forecast

Revenue Generation and Growth Potential

Initial sales data indicated modest revenues, with estimates projecting steady growth driven by:

• Market expansion through clinician education
• Increased patient acceptance
• Broader insurance coverage

Analysts forecast a compound annual growth rate (CAGR) of approximately 8-12% for the hyperhidrosis drug market over the next five years, with QBREXZA poised to capture an increasing share [2].

Challenges to Sustained Growth

Key hurdles encompass:

• Competitive pressure from invasive therapies with proven efficacy
• Patient and clinician reluctance to adopt new topical treatments
• Potential side effect concerns limiting repeat prescriptions

Future Opportunities

Innovations such as combination therapies, formulations with reduced side effects, or adjunct treatments could bolster QBREXZA’s market share. Additionally, expanding into other hyperhidrosis indications, such as palmar or craniofacial hyperhidrosis, remains under exploration.

Market Dynamics Summary

The QBREXZA market is characterized by a slow but steady growth phase influenced by unmet medical needs, patient preferences for non-invasive options, and evolving competitive pressures. The brand’s financial trajectory depends on effective clinician engagement, reimbursement policies, and potential pipeline innovations.

Key Factors Influencing Financial Outcomes

• Clinician adoption rates: Educational initiatives impact prescribing patterns.
• Patient satisfaction: Tolerance, efficacy, and side effect profile drive repeat use.
• Pricing strategies: Balance between accessibility and profitability.
• Market expansion: Geographic growth beyond North America and Europe presents significant upside.

Conclusion

QBREXZA occupies a niche in a growing hyperhidrosis market driven by demand for effective, non-invasive treatments. Its financial success hinges on overcoming barriers to adoption, maintaining regulatory compliance, and positioning against entrenched invasive therapies. The coming years will reveal whether it can sustain and accelerate its market share amid evolving competitive and clinical landscapes.

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Key Takeaways

• QBREXZA has transformed hyperhidrosis management by offering a topical, non-invasive therapy, but its market penetration remains evolving.
• Sustained growth depends on clinician education, insurance reimbursement, and addressing patient concerns regarding side effects.
• Competition from botulinum toxin injections and emerging therapies poses ongoing challenges.
• Expanding approved indications and geographic reach could significantly boost revenue.
• Monitoring regulatory updates and market acceptance will be critical for accurate financial forecasting.

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FAQs

1. What is the primary mechanism of action of QBREXZA?
QBREXZA (glycopyrronium chloride) works topically by blocking acetylcholine receptors on sweat glands, reducing stimulation and thereby decreasing sweat production.

2. How does QBREXZA compare to Botox injections in efficacy?
While Botox injections are highly effective for hyperhidrosis, QBREXZA provides comparable efficacy with a more convenient, topical application. However, individual responses vary, and some patients may prefer one over the other based on side effects, cost, and convenience.

3. What are the main side effects associated with QBREXZA?
Common adverse effects include application site reactions such as dry skin, irritation, and discomfort. Serious side effects are rare but include anticholinergic systemic effects if absorption occurs in significant amounts.

4. How does reimbursement impact QBREXZA’s market growth?
favorable insurance coverage facilitates patient access, encouraging clinician prescribing. Conversely, reimbursement challenges can delay or restrict usage, hindering growth.

5. Are there ongoing developments to enhance or expand QBREXZA’s use?
Yes. Research into formulations with improved tolerability, new indications like palmar hyperhidrosis, and combination therapies is ongoing and could positively influence future market prospects.

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References

1. D. Eriksson et al., “Prevalence and impact of hyperhidrosis,” Journal of Clinical Dermatology, 2020.
2. MarketWatch, “Hyperhidrosis Treatment Market Forecast,” 2022.