~ Buy the QELBREE (viloxazine hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

QELBREE Drug Patent Profile

When do Qelbree patents expire, and what generic alternatives are available?

Qelbree is a drug marketed by Supernus Pharms and is included in one NDA. There are five patents protecting this drug.

This drug has twenty-one 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 will be eligible for patent challenges on April 2, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 7, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QELBREE

International Patents:	21
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1
Patent Applications:	114
Drug Prices:	Drug price information 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

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

US Patents and Regulatory Information for QELBREE

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

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
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
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No			Y
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-002	Apr 2, 2021		RX	Yes	No			Y

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	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)
Canada	2735934	PROCEDE DE TRAITEMENT DE TROUBLE DEFICITAIRE DE L'ATTENTION AVEC HYPERACTIVITE (ADHD) (METHOD OF TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD))
Mexico	356727	FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)

QELBREE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Qelbree

Introduction to Qelbree

Qelbree, developed by Supernus Pharmaceuticals, is a significant player in the ADHD treatment market, particularly as the first non-stimulant ADHD drug approved by the FDA in over a decade. Here, we delve into the market dynamics and financial trajectory of Qelbree, exploring its growth, challenges, and future prospects.

Market Context: ADHD Treatment Landscape

The ADHD market is highly competitive and growing, with predictions that it will reach $16.9 billion by 2028 at a compound annual growth rate (CAGR) of four percent[3].

Key Competitors

Qelbree competes with established non-stimulant ADHD medications like Strattera (Eli Lilly) and Intuniv (Shire). Despite the presence of generics, Qelbree's unique profile, including its faster onset of action and lack of rare liver toxicity and hypotension concerns, positions it favorably[4].

Approval and Launch

FDA Approval and Initial Launch

Qelbree was approved by the FDA in 2021 for treating ADHD in children between the ages of 6 to 17. The launch was strategically timed for the second quarter to capitalize on the back-to-school season, a critical period for ADHD prescription changes[4].

Financial Performance

Revenue Growth

Qelbree has shown impressive revenue growth since its launch. In 2021, it generated $9.9 million in net product sales, which jumped to $61.3 million in 2022. For 2023, Qelbree revenues reached $140 million, and projections for 2024 indicate a potential increase to $210 million, representing a 50% annual growth[1][3].

Q1 2024 Financial Highlights

In the first quarter of 2024, Qelbree's net sales increased by 75% to $45.1 million compared to the same period in 2023. Total revenues for Supernus stood at $143.6 million, with a 12% increase in revenues excluding Trokendi XR and Oxtellar XR net product sales[2][5].

Market Share and Growth Potential

Market Share Projections

Analysts predict that capturing just a 4% to 5% share of the ADHD market could result in peak sales of over $400 million for Qelbree. Given the U.S. ADHD market's estimated value of $7.5 billion, achieving a 7% market share would be sufficient to hit peak revenues of $500 million[1][4].

Prescriber Base and Prescription Trends

The prescriber base for Qelbree has been expanding, with 16,822 prescribers in the fourth quarter of 2022, up from 14,265 in the third quarter. Increases in the average daily dose and prescription size have also contributed to Qelbree's growth[3].

Challenges and Risks

Competition and Generic Threats

The ADHD market is crowded with both branded and generic options. Qelbree faces competition from established brands like Strattera and Intuniv, as well as generic versions of these drugs. However, Qelbree's non-stimulant status and faster onset of action provide a competitive edge[4].

Seasonal Variations

Qelbree's sales may follow seasonal patterns, with the back-to-school season being a critical period. The soft back-to-school season in 2023 highlighted the potential for seasonal variability in sales growth[1].

Slowing Prescription Growth

Recent data indicates a slowdown in Qelbree's prescription growth, with quarter-to-date growth reaching about 1% in Q3 2024, down from 4% in Q2 2024. This slowdown has raised concerns about the sustainability of aggressive growth projections[1].

Strategic Initiatives and Pipeline

Sales Force and Marketing Efforts

Supernus has a dedicated sales force of 245 personnel focused on growing Qelbree revenues. The company also offers samples and patient access programs to boost the drug's profile[1][4].

Pipeline and Future Catalysts

Supernus's pipeline includes critical catalysts such as the MDD readout for SPN-820 and the fate of SPN-830. These developments are crucial for the company's long-term growth and diversification beyond Qelbree[1].

Financial Guidance and Outlook

Full-Year 2024 Guidance

Supernus has reiterated its full-year 2024 financial guidance, projecting total revenues between $580 million and $620 million, with an operating loss ranging from $30 million to break-even, and adjusted operating earnings between $80 million and $110 million[2][5].

Cash and Marketable Securities

As of March 31, 2024, Supernus's cash and marketable securities increased to approximately $309.4 million, up from $271.5 million at the end of 2023, reflecting positive operational cash flow[2].

Cost and Pricing

Comparative Pricing

Qelbree's monthly retail price is comparable to Strattera but slightly lower, at about $363 for 30 extended-release 200 mg capsules. However, generic forms of Strattera are significantly cheaper, which could impact Qelbree's market share among uninsured patients[3].

Expert Insights and Market Analysis

Analyst Projections

Analysts have revised peak sales projections for Qelbree to $400 million from $500 million due to slower-than-expected prescription growth. However, the consensus remains that Qelbree will drive significant revenues for Supernus[1].

CEO Perspective

Jack Khattar, CEO of Supernus, emphasizes that the ADHD market is not as overcrowded as perceived, with most current options being reformulations of two stimulant molecules. He highlights Qelbree's unique position as a non-controlled ADHD medication[4].

"the majority of the current options are a reformulation of just two stimulant molecules, methylphenidate and amphetamine." - Jack Khattar, CEO and President of Supernus[4].

Key Takeaways

• Revenue Growth: Qelbree has shown significant revenue growth, with a 50% annual increase projected for 2024.
• Market Share: Capturing a small market share could result in substantial peak sales for Qelbree.
• Competitive Edge: Qelbree's non-stimulant status and faster onset of action provide a competitive edge in the ADHD market.
• Seasonal Variations: Sales may follow seasonal patterns, with the back-to-school season being critical.
• Financial Guidance: Supernus projects total revenues between $580 million and $620 million for 2024.
• Pipeline and Future Catalysts: The company's pipeline includes critical developments that will impact long-term growth.

FAQs

What is Qelbree, and how does it differ from other ADHD medications?

Qelbree is a non-stimulant ADHD medication approved by the FDA in 2021. It differs from other medications like Strattera and Intuniv by its faster onset of action and lack of rare liver toxicity and hypotension concerns.

How has Qelbree performed financially since its launch?

Qelbree has shown impressive revenue growth, from $9.9 million in 2021 to $140 million in 2023, with a projected increase to $210 million in 2024.

What are the key challenges facing Qelbree in the market?

Qelbree faces competition from established brands and generic versions, as well as seasonal variations in sales growth and a recent slowdown in prescription growth.

How does Qelbree's pricing compare to other ADHD medications?

Qelbree's pricing is comparable to Strattera but slightly lower; however, generic forms of Strattera are significantly cheaper.

What are the future catalysts for Supernus's growth beyond Qelbree?

The MDD readout for SPN-820 and the fate of SPN-830 are critical catalysts for Supernus's long-term growth and diversification.

Sources

1. Seeking Alpha: "Supernus: Stock Slides As Qelbree Sales Questioned, But Positives Outweigh Negatives"
2. Patsnap Synapse: "Supernus Reports Q1 2024 Financial Results"
3. Xtalks: "Non-Stimulant ADHD Drugs: Qelbree Versus Strattera"
4. FiercePharma: "Supernus gears up for Q2 Qelbree launch, in time for back-to-school season"
5. Supernus IR: "Supernus Announces First Quarter 2024 Financial Results"