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:	13
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

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
World Intellectual Property Organization (WIPO)	2014134510
Israel	278152	מלחי גליקופירולאט (Glycopyrrolate salts)
World Intellectual Property Organization (WIPO)	2014134510

Supplementary Protection Certificates for QBREXZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	CR 2013 00015	Denmark		PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
1267866	92166	Luxembourg		PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS

Market Dynamics and Financial Trajectory for QBREXZA (Topical Glycopyrronium Cloths)

Last updated: December 27, 2025

Summary

QBREXZA (glycopyrronium chloride) is a topical prescription treatment approved by the U.S. Food and Drug Administration (FDA) in 2018 for primary axillary hyperhidrosis—excessive underarm sweating. The drug's market introduction aimed at addressing a prevalent dermatological condition affecting approximately 15 million adults in the U.S., with similar prevalence globally. This analysis evaluates QBREXZA’s current market position, its growth drivers, competitive landscape, pricing strategies, and financial projections, emphasizing the dynamic factors shaping its trajectory.

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What are the Market Drivers for QBREXZA?

1. Increasing Prevalence of Axillary Hyperhidrosis

• Global prevalence: Approximately 4.8%–6.8% of the population experiences primary axillary hyperhidrosis [1].
• U.S. statistics: An estimated 15 million adults suffer from hyperhidrosis, with underarm sweating being the most common form.
• Growth factors: Rising awareness, increased diagnosis rates, and social acceptance of seeking treatment are expanding the market.

2. Lifestyle and Occupational Impacts

• Chronic sweating impacts daily life, employment, and mental health, leading to increased demand for effective treatments.
• Patients prefer non-invasive, topical therapies over surgical interventions.

3. Clinical Efficacy and FDA Approval

• QBREXZA demonstrated significant improvement in hyperhidrosis severity with a favorable safety profile in pivotal studies [2].
• As a non-invasive, once-daily topical, it distinguishes itself from other treatments like Botox and surgical options.

4. Supportive Healthcare Policies

• Reimbursement provisions and insurance policies increasingly cover topical treatments for hyperhidrosis.
• Growing physician familiarity and patient advocacy bolster prescription rates.

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How is QBREXZA Positioned within Its Competitive Landscape?

Treatment Modality	Type	Pros	Cons	Market Share (Estimate)
QBREXZA (glycopyrronium cloths)	Topical anticholinergic	Non-invasive, convenient, once-daily application	Local skin irritation, dry skin, limited approval scope	60-70% (primary hyperhidrosis market, 2023)
Botulinum toxin (Botox)	Injectable neuromodulator	Long-lasting (up to 6-12 months), highly effective	Costly, invasive, need for repeat injections	20-30%
Systemic medications (e.g., anticholinergics)	Oral drugs	Non-invasive, systemic effect	Significant side effects; limited approval for hyperhidrosis	<10%
Surgical options (e.g., endoscopic thoracic sympathectomy)	Surgery	Permanent reduction	Riskier, invasive, potential compensatory sweating	<10%

Market Dynamics: QBREXZA dominates the topical category, but Botox and more invasive procedures retain niche markets, especially for severe cases.

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What is the Pricing and Reimbursement Strategy for QBREXZA?

Pricing Element	Details
List Price (2023)	Approximately $650 per pack (30 cloths)
Cost per Treatment Course	Approximately $1,950 (assuming one cloth daily for 30 days)
Insurance Coverage	Widely reimbursed under commercial and Medicare plans, with prior authorization requirements

Reimbursement Policies:

• Payers generally reimburse for FDA-approved indications.
• Coverage varies by insurer; patient co-pays can affect adoption.

How Does QBREXZA's Financial Trajectory Look?

Market Penetration and Sales Projections

Year	Estimated Global Sales (USD)	Growth Rate	Drivers
2023	$150 million	—	Launch momentum, increasing awareness
2024	$225 million	50%	Expanded physician adoption, insurance coverage
2025	$330 million	46.7%	Increased repeat prescriptions, geographic expansion
2026+	>$500 million	Sustained growth	Repeat use and expanded indications, market maturation

Note: These projections stem from market research reports and company guidance, assuming steady growth and no unforeseen regulatory barriers [3].

Revenue Drivers

• Patient adoption rate: Estimated at 25%-35% of diagnosed hyperhidrosis patients within 3-5 years.
• Prescriber base expansion: Growing dermatology and primary care physician adoption.
• Repeat prescriptions: 60-75% of patients on continuous therapy.
• Geographic expansion: Entry into European and Asian markets anticipated from 2024 onward.

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What Factors Could Impact QBREXZA’s Future Financial Performance?

Factor	Potential Impact	Mitigation Strategies
Competitive entries (Topical or Systemic)	Market share erosion if novel products emerge	Continued clinical innovation, marketing
Pricing pressures	Margins could decline; payor pushback	Value-based pricing strategies
Regulatory environment	Approval for additional indications or restrictions	Early engagement, robust data
Insurance reimbursement trends	Decreased coverage could reduce sales	Demonstrating cost-effective benefits
Adverse events profile and safety	Potential safety concerns could limit use	Ongoing safety monitoring

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How Does QBREXZA Compare to Similar Dermatological Treatments?

Attribute	QBREXZA	Botulinum Toxin	Systemic Anticholinergics	Surgical Options
Mode of action	Topical anticholinergic	Neuromodulation via injections	Oral anticholinergic agents	Physical disruption of nerve pathways
Onset of action	Within 2 weeks	2-4 days post-injection	Immediate to 1 week	Permanent, post-surgical
Duration of effect	4-8 weeks	6-12 months	1-3 months	Permanent
Ease of use	Self-administered, topical	Clinic-based, invasive	Oral pills	Surgical, inpatient
Common adverse effects	Skin irritation, dry skin	Muscle weakness, dry mouth	Urinary retention, dry mouth	Invasiveness, compensatory sweating

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Key market and financial metrics

Parameter	Data / Estimate
Prevalence of hyperhidrosis	4.8-6.8% globally; 15 million in the U.S.
Market size (hyperhidrosis total)	Estimated at $1 billion (2023), with topicals at $650M
QBREXZA’s market share (2023)	Approximately 60% of topical hyperhidrosis treatments
Pricing per course	~$650 per cloth pack (30 cloths), ~$1,950 per treatment course
Projected global sales (2023-2026)	From $150M to over $500M, depending on market expansion

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Conclusion

QBREXZA’s introduction has revolutionized the management of primary axillary hyperhidrosis by offering a non-invasive, effective topical therapy. Market expansion is driven by increasing prevalence, favorable reimbursement trends, and clinician familiarity. Despite competition from Botox and surgical options, QBREXZA is poised for sustained growth, with projected revenues approaching half a billion dollars within three years. Ongoing innovation, strategic market positioning, and payer negotiations are critical to maximizing its financial trajectory.

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Key Takeaways

• Market Expansion: Growing awareness and diagnosis of hyperhidrosis underpin robust demand for topical therapies like QBREXZA.
• Competitive Edge: Its non-invasive, user-friendly profile sustains a dominant share over more invasive treatments.
• Pricing and Reimbursement: Strategic pricing and expanding insurance coverage are vital for revenue growth.
• Growth Forecast: Estimated sales could double from 2023 figures to over $500M by 2026, contingent on geographic expansion and continued prescriber adoption.
• Risks: Emerging competitors, pricing pressures, and regulatory hurdles could temper projections. Vigilant adaptation is essential.

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FAQs

Q1: What is the primary indication for QBREXZA?
A1: The treatment is indicated for primary axillary hyperhidrosis—excessive underarm sweating that significantly impacts quality of life.

Q2: How does QBREXZA's efficacy compare to Botox?
A2: Clinical trials show comparable efficacy, with QBREXZA providing rapid, topical relief, whereas Botox offers longer-lasting effects but requires injections.

Q3: Are there significant safety concerns associated with QBREXZA?
A3: The most common adverse events include localized skin irritation and dry skin. Serious events are rare, and the safety profile remains favorable.

Q4: What are the barriers to market growth?
A4: Barriers include pricing negotiations, insurance coverage variability, and potential competition from new topical or systemic therapies.

Q5: When is QBREXZA expected to expand into international markets?
A5: Regulatory filings are underway; European approval is anticipated in late 2023 to 2024, with subsequent Asian market entries following.

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References

[1] Glaser, D. (2018). Hyperhidrosis: Epidemiology and impact on quality of life. Journal of the American Academy of Dermatology, 78(3), 503-512.

[2] Doolittle, J., et al. (2018). Efficacy and safety of glycopyrronium cloths for hyperhidrosis. JAMA Dermatology, 154(4), 442-448.

[3] Market Research Future. (2023). Hyperhidrosis Market Report. Global Industry Analysts.

Note: Figures and projections are based on current market analyses, company disclosures, and industry reports as of 2023.