QBREXZA Drug Patent Profile

Which patents cover Qbrexza, and when can generic versions of Qbrexza launch?

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 two 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
Clinical Trials:	3
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

Constraining patent/regulatory exclusivity:

8,859,610

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.

This potential generic entry date is based on patent 8,859,610.

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	10,052,267		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	9,744,105		Y
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	10,543,192		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	6,433,003

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
Australia	2016269524	Glycopyrrolate salts
Australia	2008314628	Topical glycopyrrolate formulations
South Korea	20150119468	글리코피롤레이트 염 (GLYCOPYRROLATE SALTS)
South Korea	20190138676

Supplementary Protection Certificates for QBREXZA

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	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	2013/014	Ireland		PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210

Market Dynamics and Financial Trajectory for Qbrexza

Overview of Qbrexza

Qbrexza, a topical anticholinergic medication, is indicated for the treatment of primary axillary hyperhidrosis in patients 9 years of age and older. It is manufactured and marketed by Journey Medical Corporation, a company focused on dermatology products.

Market Performance

Revenue Growth

In recent quarters, Qbrexza has been a key driver of revenue growth for Journey Medical Corporation. For the first quarter of 2024, Qbrexza saw a significant increase in sales, contributing to a 7% year-over-year growth in total revenues for the company, reaching $13 million[4][5].

Prescription Trends

The number of prescriptions for Qbrexza has shown substantial growth. In the first quarter of 2024, Qbrexza prescriptions increased by approximately 1,800 compared to the same period in 2023. This growth, combined with the increase in Accutane prescriptions, has been instrumental in driving the company's revenue[4].

Competitive Landscape

Market Competition

Qbrexza faces competition from other approved products for the treatment of hyperhidrosis. The market is expected to evolve with the launch of late-stage emerging therapies, which could significantly impact Qbrexza's market share. However, Qbrexza's current market position and the ongoing research in its indicated condition are expected to maintain its relevance[1].

Generic Competition

Other products in Journey Medical's portfolio, such as Targadox, are experiencing erosion due to generic competition. However, Qbrexza's unique positioning and lack of generic alternatives currently make it less susceptible to such competition[3][5].

Financial Trajectory

Revenue and Net Product Revenues

For the second quarter of 2024, Journey Medical reported net product revenues of $14.9 million, with Qbrexza and Accutane being the primary drivers of this growth. Despite a decrease in revenues from other products like Amzeeq and Zilxi, the overall revenue has seen a positive trend[2].

Expense Management

Journey Medical has been successful in reducing its selling, general, and administrative (SG&A) expenses. In the first quarter of 2024, SG&A expenses decreased by $4.9 million compared to the same period in 2023. This reduction has contributed to the company's improved financial health and profitability on an adjusted EBITDA basis[3][5].

Research and Development Costs

Research and development costs have fluctuated due to various factors, including FDA filing fees and milestone payments. For the first quarter of 2024, R&D expenses surged due to a $4 million FDA filing fee and a $3 million milestone payment related to the New Drug Application (NDA) for DFD-29, a rosacea treatment[3][4].

Adjusted EBITDA and Net Loss

Despite reporting a net loss, Journey Medical has shown positive Adjusted EBITDA. For the second quarter of 2024, the company reported a positive Adjusted EBITDA of $0.3 million, a significant improvement from the negative Adjusted EBITDA in the same period of 2023. The net loss for the first quarter of 2024 was $10.4 million, slightly higher than the previous year but manageable given the overall financial performance[2][3].

Regulatory and Development Milestones

FDA Approvals and Reviews

Qbrexza's market position is supported by its regulatory approvals. Additionally, Journey Medical's NDA for DFD-29, a potential rosacea treatment, has been accepted by the FDA with a PDUFA goal date of November 4, 2024. This upcoming approval could further bolster the company's financial trajectory[3][4].

Out-Licensing Agreements

Journey Medical has entered into out-licensing agreements, such as the one with Maruho for the rights to develop and commercialize Qbrexza in certain Asian countries, which resulted in a $19 million upfront licensing payment. These agreements help in monetizing the company's intellectual property and expanding its global reach[4].

Market Forecast

Future Growth Prospects

The market forecast for Qbrexza is positive, driven by incremental healthcare spending and extensive research in the treatment of hyperhidrosis. The product is expected to see mid to high single-digit growth, with potential for double-digit growth in the future[1][4].

Challenges and Opportunities

While Qbrexza faces challenges from emerging therapies and market competition, the company's strategic focus on cost management, portfolio expansion, and advancing new products like DFD-29 positions it for sustained growth and profitability[1][4].

Key Takeaways

• Revenue Growth: Qbrexza has driven significant revenue growth for Journey Medical Corporation, with a 7% year-over-year increase in total revenues.
• Prescription Trends: Qbrexza prescriptions have increased substantially, contributing to the company's revenue growth.
• Expense Management: Journey Medical has successfully reduced SG&A expenses, improving its financial health.
• Regulatory Milestones: The FDA's acceptance of the NDA for DFD-29 and out-licensing agreements support the company's financial trajectory.
• Market Forecast: Qbrexza is expected to see continued growth driven by healthcare spending and research in hyperhidrosis treatment.

FAQs

What is Qbrexza used for?

Qbrexza is used for the treatment of primary axillary hyperhidrosis in patients 9 years of age and older.

How has Qbrexza performed in recent quarters?

Qbrexza has seen significant revenue growth, driving a 7% year-over-year increase in total revenues for Journey Medical Corporation.

What are the key challenges facing Qbrexza in the market?

Qbrexza faces competition from other approved products and the potential impact of emerging therapies. However, it currently benefits from a lack of generic alternatives.

How has Journey Medical managed its expenses?

Journey Medical has reduced its SG&A expenses significantly, contributing to improved financial health and profitability on an adjusted EBITDA basis.

What are the future growth prospects for Qbrexza?

Qbrexza is expected to see mid to high single-digit growth, with potential for double-digit growth in the future, driven by healthcare spending and research in hyperhidrosis treatment.

Sources

1. ASDReports: "Qbrexza - Drug Insight and Market Forecast - 2030"
2. Stocktitan: "Journey Medical Corporation Reports Second Quarter 2024 Financial Results"
3. Stocktitan: "Journey Medical Corporation Reports First Quarter 2024 Financial Results and Recent Corporate Highlights"
4. Investing.com: "Earnings call: Journey Medical Q1 2024 financials show growth and promise"
5. Fortress Biotech: "Journey Medical Corporation Reports First Quarter 2024 Financial Results"

Last updated: 2024-12-17