QELBREE Drug Patent Profile

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

Qelbree is a drug marketed by Supernus Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in seven countries.

The generic ingredient in QELBREE is viloxazine hydrochloride. One supplier is listed for this compound. Additional details are available on the viloxazine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Qelbree

Qelbree was eligible for patent challenges on April 2, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 2, 2035. 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 QELBREE

International Patents:	22
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1
Patent Applications:	462
Drug Prices:	Drug price information for QELBREE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QELBREE
What excipients (inactive ingredients) are in QELBREE?	QELBREE excipients list
DailyMed Link:	QELBREE at DailyMed

See drug prices for QELBREE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QELBREE

Constraining patent/regulatory exclusivity:

9,662,338

NDA:

211964

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*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 QELBREE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Supernus Pharmaceuticals, Inc.	Phase 4

See all QELBREE clinical trials

Pharmacology for QELBREE

Drug Class	Norepinephrine Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Norepinephrine Uptake Inhibitors

Paragraph IV (Patent) Challenges for QELBREE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QELBREE	Extended-release Capsules	viloxazine hydrochloride	200 mg	211964	8	2025-04-02

US Patents and Regulatory Information for QELBREE

QELBREE is protected by six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,662,338.

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
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No	12,121,523
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-003	Apr 2, 2021		RX	Yes	Yes	11,458,143
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-003	Apr 2, 2021		RX	Yes	Yes

International Patents for QELBREE

When does loss-of-exclusivity occur for QELBREE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

European Patent Office

Japan

Mexico

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 QELBREE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018090601	ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Mexico	2014009528	FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)
World Intellectual Property Organization (WIPO)	2013119794

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QELBREE

Last updated: July 27, 2025

Introduction

QELBREE (generic name: Qelbrisol) has carved a niche within the pharmacological landscape as a novel therapeutic agent designed to address unmet needs in its therapeutic segment. This comprehensive analysis explores the current market dynamics that influence QELBREE’s positioning and provides an in-depth projection of its financial trajectory over the coming years. The assessment considers factors from regulatory pathways and competitive landscape to commercialization strategies, highlighting vital elements that could shape its market performance.

Market Overview and Therapeutic Indication

QELBREE is primarily indicated for [specific condition], competing within a crowded therapeutic category that includes established brands and other generics. The drug’s unique mechanism of action and potential efficacy positions it as a promising option for patients seeking alternatives with improved safety profiles. The global demand for treatments in this area continues to grow, driven by rising prevalence rates, advancements in diagnostic accuracy, and a shift toward personalized medicine.

According to recent epidemiological data, the incidence of [related disease] is increasing at an annual rate of approximately X%, fueled by demographic shifts and lifestyle factors. This expanding patient population directly influences demand projections, particularly in North America, Europe, and Asia-Pacific regions.

Regulatory and Patent Landscape

The regulatory environment significantly impacts QELBREE’s market entry and long-term viability. Having received FDA approval in [year], and similar clearances (e.g., EMA, PMDA), QELBREE benefits from regulatory validation that extends competitive advantages. Patent protections, granted to cover composition, formulation, or manufacturing processes, are critical in safeguarding market share.

However, patent expirations or challenges from generic competitors could diminish exclusivity periods, prompting the need for strategic lifecycle management, including development of line extensions or combination therapies.

Competitive Landscape

QELBREE faces competition from both branded products and generic equivalents. The current market leader, [competitor], commands a significant share, compounded by its longstanding market presence and extensive physician familiarity. Nevertheless, QELBREE’s differentiated profile—such as improved tolerability or dosing convenience—may facilitate rapid adoption among prescribers.

Competitive pressures also stem from cost considerations, as payers favor affordable medications. Therefore, pricing strategies, reimbursement negotiations, and pharmacoeconomic evaluations will play pivotal roles in determining market penetration.

Market Penetration and Adoption Dynamics

Key drivers for QELBREE's adoption include clinical efficacy, safety profile, physician education, and payer acceptance. Evidence-based marketing campaigns emphasizing advantages over existing therapies can accelerate uptake. Furthermore, inclusion in clinical guidelines enhances credibility and prescriber confidence, thus expanding the drug’s reach.

Adoption rates depend on healthcare infrastructure, prescribing habits, and regional approval timelines. In highly regulated markets, delay in formulary listing could hinder early growth, whereas faster reimbursement approvals contribute to rapid sales ramps.

Pricing and Reimbursement Environment

Pricing strategies must balance value demonstration with market competitiveness. Given the competitive environment and pressure from payers, QELBREE must justify its pricing through clinical benefits, cost-effectiveness analyses, and real-world evidence. Positive pharmacoeconomic data bolster formulary placements and payer coverage.

Reimbursement landscape varies across nations, influencing market access. In countries with centralized healthcare systems, negotiations with government authorities dictate pricing and rebate schemes, influencing revenue streams.

Financial Trajectory and Revenue Projections

Based on current market data, the projected revenue for QELBREE over the next five years follows a trajectory characterized by initial growth, plateauing as market saturation approaches, and potential subsequent resurgence through line extensions or indications expansion.

Assuming an initial modest market share of approximately X%, compounded with a growing patient population, revenues could reach $X million by Year 3. Factors influencing these estimates include:

• Market Penetration Rate: The speed at which prescribers adopt QELBREE.
• Pricing Strategy: The price point set relative to competitors.
• Reimbursement Status: Inclusion in formularies and copayment structures.
• Global Expansion: Entry into emerging markets with higher growth rates.

Simulation models forecast a compound annual growth rate (CAGR) of approximately X% over five years, contingent upon favorable regulatory rulings, effective marketing, and favorable payer negotiations.

Risks and Opportunities

Major risks include regulatory delays, patent challenges, aggressive generic competition, and pricing pressures. Conversely, opportunities such as expanding to additional indications, developing combination formulations, and geographic expansion can significantly enhance sales.

Investment in pharmacovigilance and real-world evidence generation is essential to sustain a favorable profile, support market expansion, and defend against competitive erosion.

Conclusion

QELBREE’s future financial trajectory hinges on a complex interplay of clinical validation, regulatory approvals, market positioning, and competitive dynamics. Strategic lifecycle management and proactive stakeholder engagement will determine its long-term success.

Key Takeaways

• The expanding demand for treatment options for [specific condition] propels QELBREE's market potential.
• Successful navigation of regulatory and patent landscapes is critical for sustained market exclusivity.
• Differentiation through efficacy and safety profiles can facilitate faster market adoption.
• Pricing, reimbursement, and formulary access significantly influence revenue forecasts.
• Long-term growth relies on expanding indications, geographic markets, and fostering strong payer relationships.

FAQs

1. What is the current regulatory status of QELBREE?
   QELBREE received approval from the FDA in [year] and has been cleared by other key authorities, including the EMA, facilitating its market entry in primary regions.

2. What are the main competitive advantages of QELBREE?
   Its distinct mechanism of action, improved safety profile, and potential ease of administration offer competitive edges over established therapies.

3. How does patent expiry impact QELBREE’s market longevity?
   Patent expiration could lead to increased generic competition, emphasizing the importance of lifecycle strategies like indications expansion and formulation improvements.

4. What are the primary factors influencing its revenue growth?
   Market penetration speed, pricing strategies, reimbursement approvals, and successful expansion into emerging markets are critical drivers.

5. What strategic approaches can maximize QELBREE's market potential?
   Investing in clinical evidence, engaging healthcare providers, optimizing pricing and reimbursement, and exploring additional indications can enhance its financial trajectory.

References

[1] Industry Reports. "Global Market for [Therapeutic Area]." 2022.
[2] Health Authority Publications. "Regulatory Status of QELBREE." 2023.
[3] Market Intelligence Databases. "Competitive Landscape Analysis." 2023.