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-six patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for GLYCOPYRRONIUM TOSYLATE

International Patents:	36
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	16
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

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			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	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 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

International Patents for GLYCOPYRRONIUM TOSYLATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3415127	FORMULATIONS TOPIQUES DE GLYCOPYRROLATE ET LINGETTE LES CONTENANT (TOPICAL GLYCOPYRROLATE FORMULATIONS AND A WIPE CONTAINING THEREOF)
Hong Kong	1212350	格隆鈉鹽 (GLYCOPYRROLATE SALTS)
Spain	2699257
Japan	6379246
South Korea	20190138676	글리코피롤레이트 염 (GLYCOPYRROLATE SALTS)
Japan	2016510037	グリコピロレート塩

Supplementary Protection Certificates for GLYCOPYRRONIUM TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
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	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
1267866	2013/014	Ireland		PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866	C300583	Netherlands		PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928

GLYCOPYRRONIUM TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glycopyrronium Tosylate

Introduction

Glycopyrronium tosylate, a topical anticholinergic, has emerged as a significant treatment option for primary axillary hyperhidrosis, a condition characterized by excessive sweating. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key factors driving its growth and its position within the hyperhidrosis treatment market.

Market Size and Growth

The hyperhidrosis treatment market, within which glycopyrronium tosylate operates, is projected to experience substantial growth. By 2027, the market is expected to reach USD 1.71 billion, growing at a CAGR of 4.0% from 2019 to 2027[4].

Key Drivers of Market Growth

Several factors are driving the growth of the hyperhidrosis treatment market and, by extension, the demand for glycopyrronium tosylate:

Increasing Awareness and Diagnosis

Growing awareness among both healthcare providers and patients about hyperhidrosis is leading to higher diagnosis rates and greater demand for treatment options. This increased awareness is a critical driver of market growth[4].

Technological Advancements

The development of advanced and sophisticated treatment options, such as glycopyrronium tosylate, is enhancing the market. Clinical trials and approvals of new treatments are expanding the available therapies, attracting more patients and healthcare providers to the market[1].

Geographical Expansion

North America, particularly the United States, is expected to dominate the hyperhidrosis treatment market due to the availability of public and private research funds, the presence of key market players, and a growing focus on precision medicine. This region's strong healthcare infrastructure and rising awareness about safer medicines are significant contributors to the market's growth[1].

Efficacy and Clinical Trials

Glycopyrronium tosylate has demonstrated strong efficacy in clinical trials. The ATMOS-1 and ATMOS-2 phase 3 trials showed that glycopyrronium tosylate significantly reduced sweating severity, sweat production, and improved quality of life for patients with primary axillary hyperhidrosis. These trials also highlighted the drug's long-term safety and efficacy, with improvements maintained over 44 weeks in the ARIDO extension study[2].

Cost-Effectiveness

A cost-effectiveness analysis comparing glycopyrronium tosylate to topical aluminum chloride revealed that glycopyrronium tosylate yields greater quality-adjusted life years (QALYs) and life years (LYs) with response, despite a higher incremental cost. The incremental cost-effectiveness ratio (ICER) of $87,238 per QALY gained suggests that glycopyrronium tosylate may be cost-effective at commonly accepted willingness to pay thresholds[5].

Competitive Landscape

The hyperhidrosis treatment market is highly competitive, with several key players including Brickell Biotech, Inc., Revance Therapeutics, Inc., AbbVie, Inc., Allergan, Inc., and Dermira, Inc. These companies are engaged in various strategies such as product launches, acquisitions, collaborations, and partnerships to expand their market presence. For instance, Fortress Biotech's acquisition of Qbrexza (glycopyrronium tosylate) from Dermira is a significant move in this market[1].

Market Trends

Emerging Markets

The expansion of healthcare infrastructure and rising disposable incomes in emerging markets are providing new growth opportunities for companies operating in the hyperhidrosis treatment space. This trend is expected to continue, driving market growth globally[4].

Patient Education and Support

Healthcare providers and manufacturers are increasingly focusing on educating patients about hyperhidrosis, its causes, and available treatment options. Support networks and online communities for patients are also growing, contributing to better patient outcomes and engagement[4].

Financial Projections

The financial trajectory for glycopyrronium tosylate is promising, given its strong market position and the growing demand for hyperhidrosis treatments. Here are some key financial projections:

• Revenue Growth: The hyperhidrosis treatment market, driven by products like glycopyrronium tosylate, is expected to reach USD 1.71 billion by 2027, indicating a robust revenue growth trajectory[4].

• Market Share: North America, particularly the United States, is expected to dominate the market, driven by factors such as increased diagnosis rates and the availability of advanced treatment options. This region's strong market presence will contribute significantly to the revenue of glycopyrronium tosylate[1].

• Cost-Effectiveness: The cost-effectiveness of glycopyrronium tosylate compared to other treatments, such as topical aluminum chloride, positions it favorably in terms of healthcare spending. This could lead to increased adoption and higher revenues[5].

Key Players and Partnerships

Companies like Allergan, Inc., and Dermira, Inc., are playing crucial roles in the market. For example, Allergan's launch of Qbrexza (glycopyrronium tosylate) cloth and Fortress Biotech's acquisition of this product from Dermira highlight the strategic moves in this market[1][4].

Regulatory Environment

Regulatory approvals are critical for the market growth of glycopyrronium tosylate. The drug has been approved in the United States for the treatment of primary axillary hyperhidrosis in patients 9 years of age and older, which has significantly boosted its market presence[2].

Conclusion

Glycopyrronium tosylate is poised for significant growth within the hyperhidrosis treatment market. Driven by increasing awareness, technological advancements, and a strong competitive landscape, this drug is expected to play a major role in the market's expansion. Its efficacy, cost-effectiveness, and strategic market positioning ensure a favorable financial trajectory.

Key Takeaways

• Growing Market: The hyperhidrosis treatment market is expected to reach USD 1.71 billion by 2027.
• Efficacy: Glycopyrronium tosylate has shown strong efficacy in reducing sweating severity and improving quality of life.
• Cost-Effectiveness: The drug is cost-effective compared to topical aluminum chloride.
• Competitive Landscape: Key players are engaging in strategic partnerships and acquisitions to expand market presence.
• Geographical Dominance: North America, particularly the United States, is expected to dominate the market.

FAQs

What is glycopyrronium tosylate used for?

Glycopyrronium tosylate is used for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating under the arms.

What are the key drivers of the hyperhidrosis treatment market?

The key drivers include increasing awareness and diagnosis rates, technological advancements, and geographical expansion into emerging markets.

How effective is glycopyrronium tosylate in clinical trials?

Glycopyrronium tosylate has shown significant efficacy in reducing sweating severity and improving quality of life in clinical trials such as the ATMOS-1 and ATMOS-2 phase 3 trials.

Is glycopyrronium tosylate cost-effective?

Yes, glycopyrronium tosylate is cost-effective compared to topical aluminum chloride, with an incremental cost-effectiveness ratio (ICER) of $87,238 per QALY gained.

Which region is expected to dominate the hyperhidrosis treatment market?

North America, particularly the United States, is expected to dominate the market due to increased diagnosis rates, advanced treatment options, and strong healthcare infrastructure.

Sources

1. Fairfield Market Research: Hyperhidrosis Treatment Market Size, Share, Growth, 2022-2029.
2. D-NB Info: Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis.
3. Market Research Intellect: Global Glycopyrrolate Market Size, Trends and Projections.
4. GlobeNewswire: Hyperhidrosis Treatment Market to Surpass USD 1.71 billion by 2027.
5. PubMed: Cost-effectiveness of topical glycopyrronium tosylate for primary axillary hyperhidrosis.