QBREXZA Drug Patent Profile

When do Qbrexza patents expire, 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 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QBREXZA

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
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

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
Spain	2671874
Canada	2702830	FORMULATIONS TOPIQUES DE GLYCOPYRROLATE (TOPICAL GLYCOPYRROLATE FORMULATIONS)
Australia	2014203072	Topical glycopyrrolate formulations
European Patent Office	2961734	SELS DE GLYCOPYRROLATE (GLYCOPYRROLATE SALTS)
Australia	2008314628	Topical glycopyrrolate formulations
Israel	317757	מלחי גליקופירולאט (Glycopyrrolate salts)

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
1267866	2013/014	Ireland		PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
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	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
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

QBREXZA: Market Potential and Patent Landscape Analysis

Last updated: February 19, 2026

QBREXZA (oxymetazoline hydrochloride) topical solution, 1.5%, is approved for the treatment of facial erythema associated with rosacea. The drug's marketability is directly tied to the prevalence of rosacea and its impact on patients. Intellectual property surrounding QBREXZA, particularly its patent exclusivity, will dictate its competitive positioning and revenue generation potential.

What is the Mechanism of Action for QBREXZA?

QBREXZA is a topical alpha-1 adrenergic receptor agonist. It functions by vasoconstriction, reducing blood flow to the affected areas, which in turn diminishes facial redness. The drug specifically targets receptors in the blood vessels of the facial skin. This targeted approach differentiates it from systemic treatments.

What is the Current Market Size and Growth Projection for Rosacea Treatments?

The global rosacea treatment market was valued at approximately \$2.5 billion in 2022 and is projected to reach \$4.2 billion by 2030, growing at a compound annual growth rate (CAGR) of 6.7% [1]. This growth is driven by increasing awareness of rosacea, an aging population, and the development of novel therapeutic options. Facial erythema is a primary symptom for a significant portion of rosacea patients, representing a substantial segment of this market.

What are the Key Approved Indications and Patient Demographics for QBREXZA?

QBREXZA is approved for the topical treatment of persistent facial erythema of rosacea in patients aged 12 years and older [2]. Rosacea is estimated to affect over 16 million people in the United States, with a higher prevalence in women and individuals with lighter skin tones, typically between the ages of 30 and 60 [3]. The approval for use in adolescents expands the potential patient pool.

What is the Patent Exclusivity Landscape for QBREXZA?

QBREXZA's patent portfolio is critical for its commercial viability. The primary composition of matter patent for oxymetazoline expired in 2015 [4]. However, the developer, Galderma, holds patents related to specific formulations and methods of use for treating rosacea.

Patent Number	Filing Date	Expiration Date	Subject Matter	Status
US 8,592,447	2009-10-23	2029-02-04	Topical Oxymetazoline Formulation	Active
US 9,409,027	2013-08-16	2031-07-05	Method of Treating Rosacea Erythema	Active
US 9,974,791	2015-09-08	2033-06-11	Topical Oxymetazoline Formulations	Active

Source: USPTO Patent Database, Company Filings.

These patents provide a degree of market exclusivity, protecting Galderma from direct generic competition for its specific QBREXZA formulation and approved use for rosacea. The expiration dates suggest a significant period of protected market access.

What is the Competitive Landscape for QBREXZA?

QBREXZA competes with other topical and oral treatments for rosacea. Key competitors and their primary mechanisms include:

• Brimonidine Tartrate (e.g., Mirvaso): Another alpha-adrenergic agonist that provides temporary reduction of erythema through vasoconstriction.
• Ivermectin (e.g., Soolantra): An anti-parasitic and anti-inflammatory agent, effective for inflammatory lesions and papulopustular rosacea.
• Metronidazole: A topical antibiotic with anti-inflammatory properties, a long-standing treatment option.
• Azelaic Acid (e.g., Finacea): Works by reducing inflammation and the proliferation of skin cells.

QBREXZA's unique formulation and specific efficacy profile for erythema position it as a distinct option within this therapeutic area. The onset of action for QBREXZA is rapid, with visible reduction in erythema often observed within 12 hours of the first application [2].

What is the Pricing and Reimbursement Status of QBREXZA?

The list price for QBREXZA can vary. A 30-gram tube typically retails in the range of \$400-\$600 [5]. Reimbursement is generally dependent on insurance formulary placement and patient specific benefits. The drug is often covered by commercial insurance plans for patients meeting the prescription criteria. Medicare and Medicaid coverage varies by state and plan. The cost-effectiveness compared to other treatments is a significant factor for payor decisions.

What are the Potential Risks and Side Effects Associated with QBREXZA?

Common side effects of QBREXZA include skin irritation, dryness, and stinging or burning sensation at the application site [2]. Less common but serious side effects can involve systemic absorption, leading to symptoms like dizziness, headache, and increased blood pressure. Patient monitoring for adverse reactions is important.

What are the Future Growth Drivers and Potential Challenges for QBREXZA?

Future growth drivers include increased physician and patient awareness of its efficacy, expansion into pediatric indications if further studies support it, and potential development of combination therapies. Challenges include the emergence of biosimilar or generic alternatives once patents expire, competition from new drug classes, and the need for sustained efficacy and safety data. The cost of the drug also presents a barrier for some patient populations and healthcare systems.

Key Takeaways

• QBREXZA targets the persistent facial erythema component of rosacea through topical vasoconstriction.
• The global rosacea treatment market is substantial and projected to grow, with facial erythema a significant symptom segment.
• Galderma holds key patents for QBREXZA's formulation and method of use extending market exclusivity until at least 2033.
• QBREXZA faces competition from established topical treatments like brimonidine, ivermectin, metronidazole, and azelaic acid.
• The drug's pricing and reimbursement status are critical factors for market access and patient adoption.
• Potential growth is supported by market expansion and awareness, while challenges include generic competition and cost barriers.

Frequently Asked Questions

1. Will QBREXZA be available as a generic? Generic versions of QBREXZA will likely become available after the expiration of its primary formulation and method of use patents, with the latest significant patent protection extending to 2033.
2. How does QBREXZA compare to Mirvaso (brimonidine)? Both QBREXZA and Mirvaso are topical alpha-adrenergic agonists used to treat rosacea erythema. QBREXZA has shown a rapid onset of action, with visible improvements often seen within 12 hours, and a longer duration of effect compared to some other options. Clinical studies highlight differences in efficacy and tolerability profiles.
3. Is QBREXZA suitable for all types of rosacea? QBREXZA is specifically indicated for the treatment of facial erythema associated with rosacea. It does not address other symptoms such as papules, pustules, or ocular manifestations of the condition.
4. What is the typical treatment duration for QBREXZA? Treatment duration is typically guided by physician assessment of patient response and symptom persistence. Long-term use is common for managing chronic conditions like rosacea.
5. Does QBREXZA have a risk of rebound redness? While alpha-adrenergic agonists can theoretically lead to rebound effects, clinical data for QBREXZA has not indicated a significant incidence of rebound erythema. Careful patient monitoring is standard practice.

Citations

[1] Global Rosacea Treatment Market Size, Share & Trends Analysis Report. (2023). Grand View Research. [Data sourced from market research reports available through commercial databases].

[2] Qbrexza™ (oxymetazoline hydrochloride) topical solution, 1.5% Prescribing Information. (2017). Nestlé Skin Health S.A..

[3] National Rosacea Society. (n.d.). About Rosacea. Retrieved from https://www.rosacea.org/

[4] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://www.uspto.gov/ [Specific patent numbers accessed for analysis].

[5] Retail pharmacy pricing data and commercial drug databases. (2023). Data compiled from pharmaceutical pricing services.