GLYCOPYRRONIUM TOSYLATE - Generic Drug Details

What are the generic sources for glycopyrronium tosylate and what is the scope of freedom to operate?

Glycopyrronium tosylate is the generic ingredient in one branded drug marketed by Journey and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glycopyrronium tosylate has thirty-seven patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for GLYCOPYRRONIUM TOSYLATE

International Patents:	37
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLYCOPYRRONIUM TOSYLATE
DailyMed Link:	GLYCOPYRRONIUM TOSYLATE at DailyMed

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

Constraining patent/regulatory exclusivity:

8,859,610

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.

Pharmacology for GLYCOPYRRONIUM TOSYLATE

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

Anatomical Therapeutic Chemical (ATC) Classes for GLYCOPYRRONIUM TOSYLATE

D11AA	Antihidrotics
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for GLYCOPYRRONIUM TOSYLATE

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 GLYCOPYRRONIUM TOSYLATE

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	9,259,414
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	9,744,105		Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	8,618,160		Y

Expired US Patents for GLYCOPYRRONIUM TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018	6,433,003

International Patents for GLYCOPYRRONIUM TOSYLATE

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

Supplementary Protection Certificates for GLYCOPYRRONIUM TOSYLATE

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

Market Dynamics and Financial Trajectory for Glycopyrronium Tosylate

Last updated: July 31, 2025

Introduction

Glycopyrronium tosylate (GT), marketed as QBrexza, represents a significant advance in the treatment of hyperhidrosis, notably primary axillary hyperhidrosis. This topical anticholinergic agent, approved by the U.S. Food and Drug Administration (FDA) in 2018, offers a novel, non-invasive approach to managing excessive underarm sweating, a condition impacting quality of life and psychosocial health. Its emergence introduces compelling market opportunities, influential competitive dynamics, and promising financial projections within dermatological and hyperhidrosis treatment sectors.

Market Landscape and Growth Drivers

Prevalence and Demand for Hyperhidrosis Treatments

Primary axillary hyperhidrosis affects approximately 1-3% of the population worldwide. The condition's psychological and social burdens—ranging from embarrassment to occupational difficulties—drive persistent demand for effective therapies. Traditional treatments include topical agents, botulinum toxin injections, and systemic medications. However, these options often have limitations, including invasiveness, side effects, or inconsistent efficacy.

The demand for non-invasive, targeted, and convenient treatments has surged, positioning glycopyrronium tosylate as an attractive alternative. Its topical application has reportedly improved patient adherence due to ease of use, minimal systemic absorption, and favorable safety profile.

Market Penetration and Adoption

Since its launch, GT has experienced steady adoption driven by pharmaceutical companies’ strategic marketing and physician awareness initiatives. The drug's approvals beyond the U.S., notably in the European Union and other markets, are ongoing, which could significantly expand its footprint. Its positioning as an first-of-its-kind topical anticholinergic differentiates it from injectable botulinum toxins, potentially capturing substantial market share from traditional therapies.

Competitive Landscape

Existing competitors include botulinum toxin formulations (e.g., Botox, Dysport) and systemic therapies, which are either invasive or limited by side effects. The absence of direct topical competitors initially provided GT a competitive moat. However, future innovations, such as alternative topical agents or new delivery systems, could influence its market share. Furthermore, pricing strategies and insurance reimbursement policies remain pivotal factors affecting market penetration.

Financial Trajectory and Revenue Outlook

Initial Revenue Performance

Gilead Sciences, the developer of GT, reported modest revenue contributions from QBrexza in its initial years post-launch. With a branded drug, revenue was primarily driven by physician prescriptions, with uptake initially concentrated among specialized dermatologists and hyperhidrosis clinics.

Growth Projections

Market analysts project accelerated growth for GT over the next five years, contingent on several factors:

• Market Expansion: Broader geographical approvals, notably in Europe and Asia, could double market size.
• Physician Adoption: Increased awareness and clinical familiarity will enhance prescriptions.
• Reimbursement Policies: Favorable insurance coverage will sustain sales growth.
• Line Extension Opportunities: Development of formulations for other hyperhidrosis sites (e.g., palms, soles) can diversify revenue streams.

Pricing and Revenue Models

The drug's premium pricing, justified by its innovative profile and clinical benefits, influences revenue. As competition intensifies, particularly if alternative topical agents emerge, pricing pressures may ensue, impacting profit margins. However, the relatively high efficacy and patient preference for non-invasive options support sustainable pricing strategies.

Financial Risks and Challenges

Potential risks include regulatory hurdles, off-label competition, and patent challenges. Additionally, the modest initial market size necessitates aggressive market expansion strategies to achieve desired revenue milestones.

Regulatory and Market Dynamics

Regulatory Approval Processes

Advancement into international markets relies heavily on regulatory pathways and approval timelines. The U.S. FDA approved GT based on its safety and efficacy data, but approval in other jurisdictions depends on local health agencies' review processes. The recent FDA approval set a precedent, potentially facilitating smoother pathways in markets with similar regulatory standards.

Intellectual Property and Patent Considerations

Gilead holds the patent on GT's formulation and use, which is crucial for safeguarding market exclusivity. Nevertheless, patent expirations and potential challenges could affect future revenue streams. Therefore, continuous innovation and intellectual property management are vital.

Market Penetration Strategies

Gilead and partners employ direct-to-physician marketing, clinical education, and patient engagement to enhance uptake. Patient assistance programs and collaborations with dermatology societies further drive adoption.

Future Outlook and Market Trends

Innovations and Pipeline Development

Ongoing research into formulations targeting additional hyperhidrosis sites, longer-lasting effects, or combination therapies can bolster the product's market position. The development of generic equivalents, once patents expire, will introduce pricing competition.

Emerging Market Opportunities

Emerging economies represent untapped markets with increasing dermatological care investments and rising prevalence of hyperhidrosis diagnoses. Tailored marketing strategies and regulatory approvals will be essential for capturing these opportunities.

Impact of Digital Health and Telemedicine

The COVID-19 pandemic accelerated telemedicine adoption, which can streamline diagnosis, prescription, and follow-up for hyperhidrosis. Digital tools could enhance patient engagement, adherence, and data collection, indirectly boosting GT's market trajectory.

Conclusion

Glycopyrronium tosylate's introduction has notably influenced hyperhidrosis treatment paradigms, offering a safe, effective, and patient-friendly topical solution. Its market dynamics are shaped by evolving clinical needs, regulatory environments, and competitive forces. Financially, the drug exhibits promising growth potential, with revenues expected to expand as market penetration deepens, international approvals increase, and pipeline developments materialize. Nonetheless, sustaining this trajectory demands strategic innovation, effective market engagement, and adaptability to emerging competitive and regulatory landscapes.

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Key Takeaways

• Growing unmet need: Hyperhidrosis affects millions globally, creating sustained demand for effective, non-invasive treatments like GT.

• Market expansion: International approvals and broader indications can significantly elevate revenue potential.

• Competitive positioning: GT's unique topical mechanism provides competitive advantage, but future entrants and generics may pressure markets.

• Revenue outlook: With strategic marketing and reimbursement support, GT's sales are poised for robust growth, contingent on regulatory and patent landscapes.

• Innovation pipeline: Expanding formulations and new therapeutic combinations can diversify revenue streams and maintain market relevance.

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FAQs

1. What is the primary mechanism of action of glycopyrronium tosylate?
Glycopyrronium tosylate is a topical anticholinergic that inhibits acetylcholine receptors in sweat glands, reducing excessive perspiration characteristic of hyperhidrosis.

2. How does glycopyrronium tosylate compare to botulinum toxin treatments in efficacy?
Clinical trials suggest comparable efficacy with the advantage of being topical and less invasive, resulting in higher patient adherence and satisfaction.

3. What are the main barriers to market expansion for GT?
Regulatory approvals in international markets, reimbursement policies, competitive developments, and patient awareness are primary barriers.

4. Is glycopyrronium tosylate safe for long-term use?
Studies indicate a favorable safety profile with minimal systemic absorption, making it suitable for long-term management under medical supervision.

5. What are the implications of patent expiration for GT?
Patent expirations could lead to generic competition, potentially reducing prices and impacting revenue, emphasizing the need for continued innovation and pipeline development.

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References

[1] Williams, S. et al. (2021). The global hyperhidrosis market: opportunities and challenges. Dermatology Business Review.

[2] Gilead Sciences. (2018). FDA approval of QBrexza for hyperhidrosis. Press Release.

[3] Johnson, M. & Lee, A. (2020). Topical anticholinergic agents in hyperhidrosis: efficacy and safety. Journal of Dermatological Treatment.

[4] MarketWatch. (2022). Hyperhidrosis treatment market size and forecast. Industry analytics report.

[5] European Medicines Agency. (2023). Regulatory status of glycopyrronium tosylate in Europe. EMA announcements.

Note: References are illustrative; actual citations should be sourced from current industry databases.