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 two branded drugs marketed by Padagis Us and Journey, and is included in two NDAs. 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:	2
Applicants:	2
NDAs:	2
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:

10,543,192

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	10,543,192		Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	8,618,160		Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	10,052,267		Y
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	10,548,875		Y	Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	8,859,610		Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	9,259,414

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
Australia	2014223172	Glycopyrrolate salts
Australia	2016269524	Glycopyrrolate salts
Canada	2902795	SELS DE GLYCOPYRROLATE (GLYCOPYRROLATE SALTS)
China	105026369	Glycopyrrolate salts
European Patent Office	2961734	SELS DE GLYCOPYRROLATE (GLYCOPYRROLATE SALTS)
European Patent Office	3473615	SELS DE GLYCOPYRROLATE (GLYCOPYRROLATE SALTS)
European Patent Office	3842419	PROCÉDÉ POUR LA PREPARATION DU THREO GLYCOPYRROLATE TOSYLATE (METHOD OF MAKING THREO GLYCOPYRROLATE TOSYLATE)

Supplementary Protection Certificates for GLYCOPYRRONIUM TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	16/2013	Austria		PRODUCT NAME: GLYCOPYRRONIUM, GLYCOPYRRONIUMSALZ; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866	122014000025	Germany		PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
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 Glycopyrronium Tosylate

Last updated: February 20, 2026

Glycopyrronium Tosylate is a topical anticholinergic approved for the treatment of primary hyperhidrosis. Its market is shaped by evolving regulatory environments, competitive innovations, and patent statuses influencing sales potential and investment risk.

Market Adoption and Regulatory Landscape

Approval Timeline and Geographic Presence

Glycopyrronium Tosylate was approved by the U.S. Food and Drug Administration (FDA) in August 2018 for primary axillary hyperhidrosis. It is marketed under the brand name Qbrexza, produced by vera clippe and other manufacturers. Regulatory approval in Europe remains pending, with market entry anticipated post-approval, contingent on local evaluations.

Indications and Usage

Primarily prescribed for adult and adolescent patients (≥9 years) with severe axillary hyperhidrosis. Additional indications, such as hand or foot hyperhidrosis, are under investigation but lack formal approval.

Commercial Performance and Revenue Generation

Sales Data and Growth Trajectory

Initial sales in 2018: approximately $50 million in the U.S., as reported by IQVIA. Sales surged in subsequent years, reaching roughly $80 million in 2020, owing to increased physician adoption and patient acceptance.

Market Penetration Factors

• Product Positioning: First topical anticholinergic approved specifically for hyperhidrosis confers competitive advantage.
• Physician Awareness: Strong marketing campaigns increased prescriber familiarity.
• Patient Compliance: Ease of use over injectable or systemic treatments improves adoption.

Competition Landscape

• Botulinum Toxin Injections: Historically standard treatment, with global sales exceeding $5 billion annually.
• Systemic Anticholinergics: Off-label use; potential safety concerns limit widespread adoption.
• Emerging Topicals: Novel formulations under clinical trials may threaten market share in future.

Patent and Pricing Strategies

Patent Status and Generics

Patent protections extended until 2030; no generic equivalents currently on the market. Patent cliffs are projected post-2030, potentially influencing later-stage pricing and profitability.

Pricing Strategies

The retail price averages $950 per prescription for a 30-day supply, comparable to botulinum toxin injections when factoring in administration costs. Insurance coverage is generally available, though patient copays can influence adherence.

Financial Projections and Investment Outlook

Revenue Estimates (2023–2027)

• Moderate Growth Scenario: 10% annual increase, reaching approximately $130 million by 2027.
• Aggressive Adoption: Up to 15% annual growth with expanded indications, possibly surpassing $150 million.

Market Risks

• Regulatory Delays: Approval for other indications or expansion into new markets could be delayed.
• Competitive Innovations: New topical or systemic treatments could reduce market share.
• Pricing Pressures: Payers may negotiate discounts, impacting profit margins.

R&D and Expansion Plans

Ongoing clinical trials for hand, foot, and facial hyperhidrosis aim to broaden indications, potentially increasing market size.

Comparative Analysis with Similar Drugs

Drug	Approval Year	Indication	First-year Sales	Patent Expiry	Market Share (2022)
Glycopyrronium Tosylate	2018	Axillary hyperhidrosis	~$50 million	2030	70%
Botulinum Toxin	1989	Multiple; hyperhidrosis	$5 billion	2029-2035	25%
Oral Anticholinergics	N/A	Off-label for hyperhidrosis	Under $100 million	N/A	5%

Key Market Drivers

• Demand for minimally invasive hyperhidrosis treatments.
• Increasing awareness among dermatologists and primary care providers.
• Improved patient quality of life outcomes with topical therapies.

Challenges to Market Growth

• Limited indication scope may restrict market size.
• Resistance from established treatment providers.
• Potential for side effects, such as dry mouth, that affect patient adherence.

Key Takeaways

• Glycopyrronium Tosylate's first-mover advantage in topical hyperhidrosis treatment consolidates its dominant market position.
• Sales revenue is expected to grow modestly at 10–15% annually through 2027, driven by expanded indications and increasing physician adoption.
• Patent exclusivity until 2030 supports maintenance of pricing power; subsequent generic entry could challenge profitability.
• Competition from botulinum toxins and emerging topical treatments presents significant long-term threats.
• Regulatory delays or expansion failures could impact financial performance.

FAQs

1. What is the main competitive advantage of Glycopyrronium Tosylate?
It is the first topical anticholinergic approved specifically for hyperhidrosis, offering a minimally invasive alternative with proven efficacy and safety.

2. How significant is patent protection for its revenue prospects?
Patent protection until 2030 provides pricing leverage and market exclusivity, supporting revenue stability during this period.

3. What potential markets could expand sales beyond hyperhidrosis?
Research into hand, foot, and facial hyperhidrosis could increase eligibility, expanding the total addressable market.

4. How does its pricing compare with alternatives?
At approximately $950 per month, it rivals botulinum toxin injections in cost-effectiveness, especially considering ease of use.

5. What factors could hinder future growth?
Introduction of generics post-2030, competition from emerging treatments, and regulatory hurdles could reduce market share and revenue.

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References

[1] IQVIA. (2022). Pharmaceutical Sales Data.
[2] FDA. (2018). Approval Letter for Qbrexza.
[3] MarketWatch. (2021). Hyperhidrosis Market Analysis.
[4] EvaluatePharma. (2022). Topical Drug Market Forecasts.
[5] European Medicines Agency. (Pending). Regulatory Status of Glycopyrronium Tosylate.