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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for viloxazine hydrochloride

International Patents:	21
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	12
Patent Applications:	272
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

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
Apnimed	Phase 2
Supernus Pharmaceuticals, Inc.	Phase 4
Supernus Pharmaceuticals, Inc.	Phase 3

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

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
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-003	Apr 2, 2021		RX	Yes	Yes			Y
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No

International Patents for viloxazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2015506980	ビロキサジンの緩和放出製剤
Japan	2018090601	ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
European Patent Office	4233915	FORMULATIONS DE LIBERATION MODIFIÉE DU VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)

Viloxazine hydrochloride Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Viloxazine Hydrochloride

Introduction

Viloxazine hydrochloride, marketed under the brand name Qelbree, is a novel non-stimulant medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 6 to 17 years. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key milestones, market performance, and future prospects.

Market Context

The ADHD market has seen significant growth over the years. From 2012 to 2021, the number of stimulant prescriptions increased by 45%, with a notable rise in prescriptions per patient per year[4].

Product Overview

Qelbree (viloxazine extended-release capsules) is a non-stimulant ADHD treatment, which distinguishes it from traditional stimulant medications. This differentiation is crucial as it addresses a segment of the market looking for alternative treatments with potentially fewer side effects.

Regulatory Milestones

• Approval and Launch: Qelbree was approved by the FDA in April 2021 for the treatment of ADHD in pediatric patients. The commercial launch occurred in the second quarter of 2021[3].
• Expansion Plans: Supernus Pharmaceuticals plans to submit a supplemental New Drug Application (sNDA) for Qelbree in adults in the second half of 2021, aiming to expand its market reach to include the adult ADHD segment, which represents approximately half of the total ADHD market in the US[3].

Market Performance

• Initial Reception: The launch of Qelbree has been part of Supernus Pharmaceuticals' strategic expansion into the ADHD market. Despite the challenges posed by the COVID-19 pandemic, the company has reported positive initial reception for Qelbree.
• Sales Growth: While specific sales figures for Qelbree are not detailed in the latest reports, the overall performance of Supernus Pharmaceuticals' products, including Trokendi XR and Oxtellar XR, has shown resilience and growth. This trend is expected to continue with Qelbree as it gains market traction[3].

Financial Implications

• Revenue Contribution: The addition of Qelbree to Supernus Pharmaceuticals' portfolio is expected to contribute significantly to the company's revenue. Given the size of the ADHD market and the potential for Qelbree to capture a substantial share, especially with its non-stimulant profile, the financial impact is anticipated to be positive.
• Research and Development: The development and commercialization of Qelbree have involved substantial research and development expenses. However, these investments are expected to pay off as the drug gains market acceptance and expands its user base[2].

Competitive Landscape

• Non-Stimulant Market: Qelbree operates in the non-stimulant segment of the ADHD market, which, although smaller than the stimulant segment, offers a unique selling proposition. About 90% of non-stimulant prescriptions are for existing therapies, indicating a stable and potentially growing market[4].
• Competitive Advantage: As a non-stimulant, Qelbree avoids the controlled substance designation, which can be a significant advantage in terms of prescribing and patient compliance.

Future Prospects

• Adult Market Expansion: The planned sNDA submission for Qelbree in adults is a critical milestone. If approved, it will significantly expand the drug's market potential, targeting a segment that accounts for approximately half of the total ADHD market in the US[3].
• Strategic Partnerships: Supernus Pharmaceuticals is actively exploring strategic partnerships, including in-licensing products and co-promotion agreements, which could further enhance Qelbree's market reach and penetration[3].

Challenges and Risks

• Regulatory Approvals: The success of Qelbree is contingent on regulatory approvals, particularly for the adult indication. Any delays or setbacks in the approval process could impact the drug's financial trajectory.
• Market Competition: While Qelbree's non-stimulant profile is a strength, it still faces competition from established stimulant and non-stimulant ADHD treatments. The company must continue to demonstrate the therapeutic benefits and safety of Qelbree to maintain and grow its market share[2].

Financial Guidance and Projections

• Operating Earnings: Supernus Pharmaceuticals has provided financial guidance that includes the expected impact of Qelbree on its operating earnings. The company has adjusted its selling, general, and administrative expenses and operating earnings guidance to reflect the commercial launch and ongoing activities related to Qelbree[2].
• Revenue Growth: The company's strong balance sheet and operational flexibility position it well for continued revenue growth, with Qelbree expected to be a significant contributor to this growth.

Key Takeaways

• Market Differentiation: Qelbree's non-stimulant profile differentiates it in the ADHD market.
• Regulatory Milestones: Approval and commercial launch in pediatric patients, with plans for adult market expansion.
• Financial Impact: Expected to contribute significantly to Supernus Pharmaceuticals' revenue and operating earnings.
• Competitive Landscape: Operates in a stable non-stimulant segment with potential for growth.
• Future Prospects: Expansion into the adult ADHD market and strategic partnerships are key to future growth.

FAQs

Q: What is Qelbree, and how is it different from other ADHD treatments? A: Qelbree (viloxazine extended-release capsules) is a non-stimulant medication approved for the treatment of ADHD in pediatric patients. It differs from traditional stimulant medications, offering an alternative treatment option.

Q: When was Qelbree approved and launched? A: Qelbree was approved by the FDA in April 2021 and commercially launched in the second quarter of 2021.

Q: What are the future plans for Qelbree? A: Supernus Pharmaceuticals plans to submit a supplemental New Drug Application (sNDA) for Qelbree in adults in the second half of 2021 to expand its market reach.

Q: How does Qelbree fit into Supernus Pharmaceuticals' overall strategy? A: Qelbree is part of Supernus Pharmaceuticals' strategy to expand its presence in the CNS market, particularly in ADHD, and to offer a diverse portfolio of treatments.

Q: What are the potential risks and challenges for Qelbree? A: The success of Qelbree is contingent on regulatory approvals, and it faces competition from established ADHD treatments. Any delays in approvals or market competition could impact its financial trajectory.

Sources

1. Supernus Pharmaceuticals Form 10-Q - [PDF]
2. Supernus Provides Regulatory Updates for SPN-812 and SPN-830 - [News Release]
3. Supernus Pharmaceuticals 2021 Annual Report - [PDF]
4. IQVIA Report on Stimulant Trends from 2012-2021 - [PDF]
5. Viloxazine extended-release capsules as an emerging treatment for ADHD - [Journal Article]