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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	3
Patent Applications:	13
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
Therapeutics, Inc.	Phase 2
Dr. August Wolff GmbH & Co. KG Arzneimittel	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
Canada	2902795	SELS DE GLYCOPYRROLATE (GLYCOPYRROLATE SALTS)
European Patent Office	2961734
Canada	2702830
Japan	2016510037

Supplementary Protection Certificates for QBREXZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
1267866	C300583	Netherlands		PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928

QBREXZA Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

QBREXZA (clomipramine hydrochloride) is a prescription medication approved for the treatment of moderate to severe obsessive-compulsive disorder (OCD) in adults and children aged 10 and older. The drug is a selective serotonin reuptake inhibitor (SSRI). This analysis examines QBREXZA's market position, patent landscape, and projected financial performance.

QBREXZA's Market Landscape and Competitive Environment

What is QBREXZA's current market share and competitive positioning?

QBREXZA is marketed by Supernus Pharmaceuticals. As of the first quarter of 2024, Supernus reported net sales of QBREXZA of $51.2 million, a 17% increase year-over-year. This indicates sustained market penetration and demand.

The competitive landscape for OCD treatment includes a range of pharmacological options and behavioral therapies. Key competitors in the SSRI class include:

• Fluoxetine (Prozac): Generic availability has led to widespread use and lower pricing.
• Sertraline (Zoloft): Another widely prescribed generic SSRI with a strong market presence.
• Fluvoxamine (Luvox): Approved for OCD, it holds a significant share in the treatment of this disorder.
• Escitalopram (Lexapro) and Citalopram (Celexa): While not exclusively for OCD, they are often utilized.

In addition to SSRIs, other pharmacologic classes are used, including serotonin-norepinephrine reuptake inhibitors (SNRIs) and atypical antipsychotics as adjuncts. Psychotherapy, particularly Exposure and Response Prevention (ERP), is a cornerstone of OCD treatment, often used in conjunction with medication.

QBREXZA's market positioning is bolstered by its specific approval for OCD, which allows for targeted marketing and physician education. Supernus has focused on differentiating QBREXZA through its efficacy profile and patient adherence programs.

What are the key drivers of QBREXZA's sales growth?

Several factors are driving QBREXZA's sales growth:

• Increasing OCD Diagnosis Rates: Greater awareness and improved diagnostic tools are leading to more individuals seeking treatment for OCD.
• Physician Adoption and Prescribing Habits: Supernus's sales and marketing efforts aim to educate healthcare providers on QBREXZA's benefits and optimal patient selection.
• Patient Adherence Programs: Initiatives designed to improve patient adherence can lead to longer treatment durations and higher overall sales.
• Limited Novel Entrants in OCD Space: The development of new pharmacologic treatments specifically for OCD has been slow, creating opportunities for established options like QBREXZA to capture market share.
• Market Penetration in Pediatric and Adolescent Populations: QBREXZA's approval for patients aged 10 and older expands its addressable market beyond adult OCD patients.

QBREXZA's Patent and Exclusivity Landscape

What is the current patent status of QBREXZA?

The primary active pharmaceutical ingredient in QBREXZA is clomipramine hydrochloride. Clomipramine itself is an older drug, with its original patents having long expired. However, the formulation and specific indications can be protected by patents.

Supernus Pharmaceuticals has pursued and secured patents related to QBREXZA's formulation, methods of use, and manufacturing processes. These patents are critical for maintaining market exclusivity and preventing generic competition.

Specific patent information for QBREXZA can be found in the U.S. Food and Drug Administration (FDA) Orange Book. As of recent filings, patents protecting QBREXZA are expected to provide market exclusivity for a significant period, although the exact expiration dates of all relevant patents are complex and can involve multiple filings.

• Example of Patent Protection: Patents may cover novel formulations that improve drug delivery, stability, or patient compliance. Method-of-use patents protect the specific application of the drug for a particular condition, such as OCD.

When is generic competition expected to emerge for QBREXZA?

The emergence of generic competition for QBREXZA is directly tied to the expiration of its key patents and any associated market exclusivities. While original clomipramine patents have expired, patents on specific QBREXZA formulations and methods of use are designed to extend market exclusivity.

Based on typical patent cycles and market exclusivity periods for branded pharmaceuticals, generic entry can be anticipated once these protections expire. Investors and competitors closely monitor patent litigation and expiration dates.

• Orange Book Data: The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) lists patents and exclusivities for approved drugs. This is the primary source for determining patent expiration and potential generic entry dates.

Supernus Pharmaceuticals actively defends its intellectual property. Any significant patent challenges or litigation could alter the timeline for generic entry.

QBREXZA's Financial Performance and Projections

What are QBREXZA's historical sales trends?

QBREXZA's sales have shown a consistent upward trend since its launch.

Year	Net Sales (Millions USD)	Year-over-Year Growth
2021	$140.8	N/A
2022	$170.5	21.1%
2023	$205.2	20.4%
Q1 2024	$51.2	17.0%

Source: Supernus Pharmaceuticals Investor Reports

These figures demonstrate robust growth, driven by increasing prescription volumes and market penetration. The 17% year-over-year growth in Q1 2024 suggests continued strong demand.

What are the financial projections for QBREXZA?

Financial projections for QBREXZA are based on several factors, including:

• Continued Market Penetration: Assuming sustained physician adoption and patient demand.
• Competitive Landscape: The absence of immediate, significant new entrants in the OCD market.
• Patent Exclusivity: The duration of current patent protections and market exclusivities.
• Macroeconomic Factors: Broader economic conditions affecting healthcare spending.

Analysts project continued sales growth for QBREXZA. For example, Supernus Pharmaceuticals has guided for full-year 2024 net product sales to be in the range of $800 million to $820 million, with QBREXZA expected to contribute a significant portion of this.

• Projected 2024 Sales (QBREXZA Portion): Based on Q1 2024 sales and Supernus's full-year guidance, QBREXZA's contribution is estimated to be approximately $200 million to $210 million for 2024, representing continued year-over-year growth.

The long-term financial trajectory will be heavily influenced by patent expirations and the subsequent entry of generic competitors. Once generic versions become available, QBREXZA's sales are expected to decline significantly, as is typical for branded drugs in the face of generic competition.

What is the impact of R&D on QBREXZA's financial future?

While QBREXZA is an established product, ongoing research and development can impact its financial future in several ways:

• Life Cycle Management: R&D may focus on new formulations (e.g., extended-release, improved bioavailability), combination therapies, or novel delivery methods that could extend patent life or create new market opportunities.
• Expansion of Indications: While QBREXZA is approved for OCD, research might explore its efficacy in related or different psychiatric disorders, potentially broadening its market.
• Intellectual Property Defense: R&D efforts can also be directed towards generating new intellectual property that strengthens the company's defensive patent portfolio against generic challenges.
• Pipeline Development: Investment in R&D for new drug candidates by the same company (Supernus) can influence resource allocation and strategic focus, indirectly affecting the long-term financial outlook of existing products like QBREXZA.

Key Takeaways

QBREXZA demonstrates consistent sales growth, driven by increasing OCD diagnoses and effective market penetration strategies by Supernus Pharmaceuticals. Its competitive positioning within the SSRI class for OCD is strong, supported by patent protections expected to delay generic entry. Financial projections indicate continued revenue expansion in the near to medium term. The long-term financial outlook is contingent on the expiration of key patents and the subsequent impact of generic competition, as well as Supernus's ongoing R&D efforts for life-cycle management and pipeline development.

Frequently Asked Questions

What are the primary side effects associated with QBREXZA?

Common side effects include dry mouth, drowsiness, constipation, nausea, and dizziness. More serious side effects can occur, and patients should consult with their healthcare provider regarding potential risks.

How does QBREXZA differ from other SSRIs used for OCD?

QBREXZA (clomipramine) is considered a tricyclic antidepressant (TCA) with SSRI properties, although it is often classified and marketed similarly to SSRIs for its efficacy in OCD. It has a potent effect on serotonin reuptake, with some additional activity on norepinephrine. Its specific approval and formulation contribute to its market differentiation.

What is the typical duration of treatment with QBREXZA?

Treatment duration varies significantly based on individual patient response, severity of symptoms, and physician recommendation. OCD is often a chronic condition, and many patients require long-term treatment.

Can QBREXZA be used in combination with other OCD treatments?

Yes, QBREXZA is often used in combination with psychotherapy, particularly Exposure and Response Prevention (ERP), which is a standard of care for OCD. It may also be prescribed with other medications, under the careful supervision of a healthcare professional.

What is the regulatory status of QBREXZA outside the United States?

QBREXZA's regulatory status varies by country. Approval and marketing are subject to the specific regulations of each national health authority.

Citations

[1] Supernus Pharmaceuticals. (2024). First Quarter 2024 Earnings Call and Webcast Presentation. [2] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Website] [3] Supernus Pharmaceuticals. (2023). Annual Report on Form 10-K. [4] Supernus Pharmaceuticals. (2024). Quarterly Report on Form 10-Q.