Viloxazine hydrochloride - Generic Drug Details

What are the generic sources for viloxazine hydrochloride and what is the scope of freedom to operate?

Viloxazine hydrochloride is the generic ingredient in one branded drug marketed by Supernus Pharms and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Viloxazine hydrochloride has twenty-two patent family members in seven countries.

One supplier is listed for this compound.

Summary for viloxazine hydrochloride

International Patents:	22
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	13
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for viloxazine hydrochloride
What excipients (inactive ingredients) are in viloxazine hydrochloride?	viloxazine hydrochloride excipients list
DailyMed Link:	viloxazine hydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

9,662,338

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 viloxazine hydrochloride

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

Sponsor	Phase
Supernus Pharmaceuticals, Inc.	PHASE4
Apnimed	Phase 2
Supernus Pharmaceuticals, Inc.	Phase 4

See all viloxazine hydrochloride clinical trials

Pharmacology for viloxazine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for viloxazine hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for VILOXAZINE HYDROCHLORIDE

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 viloxazine hydrochloride

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	9,358,204		Y
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-002	Apr 2, 2021		RX	Yes	No
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-002	Apr 2, 2021		RX	Yes	No	9,603,853

International Patents for viloxazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	6510093
Japan	2015506980	ビロキサジンの緩和放出製剤
Japan	2019123736	ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for Viloxazine Hydrochloride: A Comprehensive Analysis

Introduction
Viloxazine hydrochloride, initially developed as an antidepressant in the 1970s, has recently re-emerged in the pharmaceutical landscape primarily for its potential in treating Attention Deficit Hyperactivity Disorder (ADHD). Its unique pharmacological profile and evolving regulatory status have influenced market dynamics and projected financial trajectories. This article examines the factors shaping its current and future market standing, identifying key drivers, challenges, and strategic considerations for stakeholders.

Pharmacological Profile and Therapeutic Rationale
Viloxazine hydrochloride functions as a selective serotonin reuptake inhibitor (SSRI) with additional noradrenergic properties. Unlike traditional stimulants used for ADHD—such as methylphenidate and amphetamines—viloxazine offers a non-stimulant profile, potentially reducing abuse liability and side effects. Its initial approval in the 1970s as an antidepressant, followed by withdrawal from some markets, shifted its focus until recent interest was renewed with pediatric and adult ADHD clinical trials. The drug's efficacy in reducing core ADHD symptoms and a better tolerability profile are central to its market resurgence.

Market Landscape and Competitive Environment

1. Historical Context and Regulatory Resurgence
   Viloxazine's decline in the global market stemmed from the advent of newer antidepressants and emergent safety concerns, leading to withdrawal in several jurisdictions. However, recent Phase III trial successes, coupled with regulatory approvals in certain regions (notably the U.S.), have rekindled investor and pharmaceutical industry interest. The U.S. Food and Drug Administration (FDA) approval of viloxazine (marketed as Qelbree® by Supernus Pharmaceuticals) in 2021 for pediatric ADHD marked a significant turning point, positioning it as a non-stimulant alternative.

2. Competitive Dynamics
   The ADHD treatment market is highly competitive, dominated by stimulants—methylphenidate (e.g., Ritalin), amphetamines (e.g., Adderall)—and non-stimulants such as atomoxetine (Strattera) and guanfacine. Viloxazine offers differentiation through its non-stimulant, non-controlled status, appealing to patients and parents concerned about abuse potential. Its safety profile further distinguishes it in cases where stimulant contraindications exist. Nevertheless, clinical efficacy, approval scope, and market acceptance remain critical determinants for its success amidst established therapies.

3. Market Penetration and Adoption
   Initial adoption hinges on prescriber familiarity and education, payer preferences, and insurance reimbursement policies. As a relatively new entrant, viloxazine's uptake may be gradual, constrained by prescriber conservatism and competition from well-established drugs. However, its positioning as a non-stimulant with a favorable side effect profile could accelerate its acceptance, especially in pediatric populations sensitive to stimulant-related side effects.

Financial Trajectory and Revenue Projections

1. Market Size and Growth Potential
   The global ADHD therapeutics market is projected to expand at a CAGR of approximately 6-8% over the next five years, driven by increasing diagnosis rates and expanding indications. The U.S. remains the largest market, accounting for nearly 70% of global ADHD drug sales, with Asia-Pacific and Europe showing rising adoption. It is estimated that the ADHD market will approach $15 billion worldwide by 2025.

2. Revenue Generation for Viloxazine
   Supernus Pharmaceuticals reported U.S. sales of Qelbree reaching approximately $200 million in 2022, with continued growth anticipated as pricing strategies, insurance coverage, and prescriber awareness improve. The drug's financial trajectory depends on several factors:

• Market Penetration: Early adoption is promising, but long-term revenue will depend on expanding indications, such as adult ADHD and comorbid conditions.
• Pricing Strategy: Maintaining competitive yet profitable pricing, aligned with payers’ reimbursement policies, will be essential.
• Geographic Expansion: Entering international markets post-approval could significantly augment revenue streams. Regulatory approvals in Canada, Europe, and Asia are pivotal milestones.
• Pipeline and Line Extensions: Potential development of oral formulations, long-acting variants, or combination therapies could bolster lifetime value.

3. Competitive Risks and Market Challenges
   Market growth could be challenged by pricing pressures, generic entries, and competition from emerging non-stimulant therapies like tenex or novel agents in clinical pipelines. Additionally, safety concerns or regulatory hurdles, such as restrictions on use, could impact financial projections.

Regulatory and Market Risks

• Approval Variability: Differential approval processes across regions may delay or restrict viloxazine's global market penetration.
• Reimbursement Pressures: Payers' cost-containment measures could limit sales unless demonstrated superiority or cost-effectiveness.
• Patent and Exclusivity: Patent expirations could usher in generics, impacting pricing and revenues. Supernus’s patent portfolio and exclusivity terms are thus strategic assets.
• Post-Marketing Surveillance: Safety signals or adverse events could hinder market acceptance or prompt restrictions.

Strategic Implications for Industry Stakeholders

1. Manufacturers and Investors
   Investment in clinical development, geographically strategic expansion, and marketing capabilities are crucial. Diversifying indications and combining viloxazine with other therapeutics could enhance market share. Active engagement with regulatory authorities to secure expedited pathways and label expansions can accelerate revenue growth.

2. Payers and Healthcare Providers
   Cost-effectiveness data, safety profiles, and comparative efficacy studies will influence formulary placements. Education initiatives highlighting viloxazine’s advantages can facilitate adoption.

3. Patients and Advocacy Groups
   Awareness campaigns emphasizing non-stimulant benefits can drive demand, particularly within pediatric populations concerned about stimulant misuse.

Future Outlook and Market Evolution

Viloxazine hydrochloride is poised for a growth trajectory aligned with the ADHD market expansion, but its ultimate success hinges on regulatory approvals beyond the U.S., competitive positioning, and ongoing clinical evidence. As a non-stimulant alternative with a promising safety profile, it could carve a significant niche, especially in populations contraindicated for stimulants. The near-term financial outlook suggests revenues could approach or surpass $500 million globally within the next five years, contingent upon market acceptance, pipeline development, and strategic global expansion.

Key Takeaways

• Viloxazine hydrochloride’s transformation from an antidepressant to an ADHD treatment exemplifies adaptive drug repositioning and lifecycle management.
• Its non-stimulant profile and safety advantages position it favorably among ADHD therapies, especially within pediatric populations.
• Growth prospects are driven by regulatory approvals, market expansion, reimbursement strategies, and clinical validation.
• Competitive pressure from established drugs and emerging therapies remains a significant hurdle, emphasizing the need for strategic differentiation and continued innovation.
• Success depends on geographic expansion, pipeline development, and demonstrating long-term value to prescribers, payers, and patients.

FAQs

1. What distinguishes viloxazine hydrochloride from other ADHD medications?
   Viloxazine offers a non-stimulant, non-controlled profile with potentially fewer side effects and lower abuse liability, appealing to both clinicians and families concerned about stimulant misuse.

2. Is viloxazine approved globally for ADHD treatment?
   As of 2023, regulatory approvals are primarily confined to the U.S. (FDA-approved as Qelbree®). Future approvals in Europe, Canada, and Asia are under consideration based on ongoing clinical data and regulatory submissions.

3. What are the primary market barriers for viloxazine’s adoption?
   Barriers include established preferences for stimulant medications, reimbursement policies, limited international approval, and the need for long-term safety and efficacy data to foster broader trust and prescriber confidence.

4. How does viloxazine’s patent landscape influence its financial prospects?
   Patent protection and exclusivity rights are critical to safeguarding market share and revenue streams; patent expirations could lead to generic competition, affecting profitability.

5. What is the long-term potential for viloxazine hydrochloride beyond ADHD?
   Its pharmacological profile suggests potential for expanding into other indications such as depression, anxiety, or comorbid conditions, which could diversify revenue streams and strengthen its market position.

References

1. [1] Supernus Pharmaceuticals. Qelbree (viloxazine extended-release capsules) prescribing information. 2021.
2. [2] MarketResearch.com. ADHD therapeutics market analysis, 2022.
3. [3] FDA. FDA approves Qelbree for pediatric ADHD, 2021.
4. [4] IQVIA Institute. The future of ADHD treatment, 2022.
5. [5] Pharma Intelligence. Market forecasts for ADHD drugs, 2023.

Note: The data presented herein derive from publicly available industry reports, regulatory filings, and market analyses as of early 2023.