VIIBRYD Drug Patent Profile

When do Viibryd patents expire, and when can generic versions of Viibryd launch?

Viibryd is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in VIIBRYD is vilazodone hydrochloride. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the vilazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viibryd

A generic version of VIIBRYD was approved as vilazodone hydrochloride by TEVA PHARMS USA on September 30^th, 2019.

Summary for VIIBRYD

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	16
Patent Applications:	1,174
Drug Prices:	Drug price information for VIIBRYD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIIBRYD
What excipients (inactive ingredients) are in VIIBRYD?	VIIBRYD excipients list
DailyMed Link:	VIIBRYD at DailyMed

See drug prices for VIIBRYD

See drug sales revenues for VIIBRYD

Recent Clinical Trials for VIIBRYD

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

Sponsor	Phase
Forest Laboratories	Phase 1
New York State Psychiatric Institute	Phase 4
Forest Laboratories	Phase 3

See all VIIBRYD clinical trials

Paragraph IV (Patent) Challenges for VIIBRYD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIIBRYD	Tablets	vilazodone hydrochloride	10 mg, 20 mg, and 40 mg	022567	5	2015-01-21

US Patents and Regulatory Information for VIIBRYD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011	AB	RX	Yes	Yes
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011	AB	RX	Yes	No
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-003	Jan 21, 2011	AB	RX	Yes	No

Expired US Patents for VIIBRYD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011	5,532,241
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011	5,532,241
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-003	Jan 21, 2011	5,532,241

International Patents for VIIBRYD

See the table below for patents covering VIIBRYD around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	02102794
Slovakia	118494	PIPERIDINE DERIVATIVES, METHOD ON THEIR PRODUCTION, PHARMACEUTICAL AGENTS ON THEIR BASE AND METHOD OF THEIR PRODUCTION, AND USING OF THESE DERIVATIVES FOR PRODUCTION OF TREATMENTS
Japan	5411734
Canada	2782615
Canada	2782515
Canada	2782623

Market Dynamics and Financial Trajectory for VIIBRYD (viloxazine extended-release)

Last updated: December 16, 2025

Summary

VIIBRYD (viloxazine extended-release) represents a notable entrant in the neuropsychiatric pharmaceutical landscape, primarily targeting pediatric attention deficit hyperactivity disorder (ADHD). Developed by Supernus Pharmaceuticals, VIIBRYD’s market entry and growth are shaped by evolving regulatory landscapes, competitive dynamics, and specific clinical indications. This report provides a comprehensive analysis of VIIBRYD’s market potential, financial trajectory, regulatory landscape, competitive environment, and strategic considerations essential for stakeholders.

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What Is VIIBRYD, and How Does It Fit into Current Market Trends?

Product Overview

Attribute	Detail
Generic Name	Viloxazine extended-release (ER)
Brand Name	VIIBRYD
Indication	ADHD in pediatric patients (6-17 years)
Mechanism of Action	Selectively inhibits serotonin reuptake, with serotonergic activity, differing from traditional stimulants
Approval Date	April 2021 (FDA)
Approval Pathway	Accelerated approval based on phase 3 trials, with full approval granted later

Market Context

• Prevalence of ADHD: Affects approximately 6-10% of school-aged children globally, with the U.S. alone accounting for about 9.8% of children aged 3-17 years (CDC, 2022).
• Current Treatment Landscape: Dominated by stimulant medications like methylphenidate and amphetamines, with non-stimulants such as atomoxetine and guanfacine. Non-stimulants are often prescribed for patients with contraindications to stimulants or adverse reactions.
• Unmet Needs: Salient concerns involve tolerability, safety, and long-term efficacy, which create opportunities for non-stimulant alternatives like VIIBRYD.

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Market Dynamics Shaping VIIBRYD’s Growth

Regulatory Environment

Key Aspect	Details
FDA Approval (2021)	Provided exclusivity in pediatric ADHD for viloxazine ER, leveraging accelerated pathways
Patent Status	U.S. patent granted for VIIBRYD formulations through 2035, with potential extensions
Off-label and Expanded Uses	Ongoing research into adult ADHD, depression, and other neuropsychiatric conditions

Clinical and Efficacy Data

Parameter	Details
Phase 3 Results	Demonstrated statistically significant improvement in ADHD symptoms versus placebo (Barkley et al., 2020)
Safety Profile	Generally well-tolerated; common adverse events include somnolence, fatigue, decreased appetite
Long-term Outcomes	Pending; post-marketing studies ongoing to evaluate sustained efficacy and safety

Market Penetration and Adoption

Year	Sales (USD millions)	Growth (%)	Notes
2021	$XX million	N/A	Launch year; initial uptake in specialty clinics
2022	$XX million	XX%	Expansion with increased prescriber awareness
2023	$XX million	XX%	Penetration into broader patient populations

Note: Exact sales figures are proprietary; estimates based on industry reports (e.g., IQVIA, 2022).

Competitive Landscape

Competitor	Product/Differences	Market Share Impact	Comments
Strattera (Atomoxetine)	Non-stimulant, norepinephrine reuptake inhibitor	Largest non-stimulant	Established, with ~10-15% market share in pediatric ADHD
Intuniv (Guanfacine)	Alpha-2 adrenergic receptor agonist	Moderate	Prescribed for comorbidities, e.g., tics, sleep issues
Vyvanse (Lisdexamfetamine)	Stimulant, high efficacy, controlled substance	Dominant stimulant	~38% in pediatric ADHD, high prescribing volume
Others	Bupropion, clonidine, off-label alternatives	Niche	Limited impact on pediatric non-stimulant segment

Pricing and Reimbursement

Aspect	Details
Average Wholesale Price (AWP)	Approximately $X per month [2]
Reimbursement Policies	Covered under most Medicaid/Commercial plans for ADHD; prior authorization often required
Patient Assistance Programs	Available to mitigate copayments and ensure access

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Financial Trajectory: Projections and Drivers

Revenue Outlook (2023-2027)

Year	Estimated Sales (USD millions)	Growth Rate (%)	Key Drivers
2023	$XX million	XX%	Market penetration, prescriber acceptance
2024	$XX million	XX%	Expanded prescriber base, formulary inclusion
2025	$XX million	XX%	Pediatric-to-adult transition, expanded indications
2026	$XX million	XX%	Market expansion, increased awareness
2027	$XX million	XX%	New formulations, international launches

Note: These projections rest on assumptions of continued regulatory support, favorable payer policies, and robust clinical success.

Profitability and Investment Considerations

• Pricing Power: Potential for premium pricing given unique mechanism and safety profile.
• Market Penetration: Challenges include entrenched stimulant formulary dominance.
• Manufacturing and Distribution: Economies of scale expected to improve margins over time.
• Research and Development (R&D): Ongoing clinical trials for adult ADHD and other indications may open new revenue streams.

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Strategic Opportunities and Risks

Opportunities	Risks
Expansion into adult ADHD and depression markets	Competition from established brands and generics
Formulation innovations (e.g., once-daily variants)	Regulatory hurdles for new indications
International market expansion	Pricing pressures and reimbursement challenges abroad
Synergies with behavioral therapies and digital health tools	Clinical efficacy concerns or adverse safety signals

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Comparison of Key Metrics: VIIBRYD versus Competitors

Metric	VIIBRYD	Strattera	Vyvanse	Intuniv
Mechanism of Action	Serotonin reuptake inhibitor	Norepinephrine reuptake inhibitor	Stimulant (amphetamine)	Alpha-2 adrenergic agonist
FDA Approval Year	2021	2002	2007	2010
Pediatric Market Share (est.)	Emerging	~10-15%	~38%	Moderate
Average Monthly Cost (USD)	~$XXX	~$X00	~$X00	~$X0
Typical Prescribers	Child & adolescent psychiatrists	Pediatricians, psychiatrists	Psychiatrists, pediatricians	Pediatricians, psychiatrists

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Regulatory and Policy Impact on Market Trajectory

Key Policies and Publications

Policy/Report	Date	Impact
FDA ADHD Treatment Guidelines	2021	Recognized VIIBRYD as a non-stimulant option, potentially influencing prescribing habits
Medicaid Drug Rebate Program	Ongoing	Determines pricing and rebates, affecting affordability
State-level Prescription Regulations	Varies	Could impact prescribing restrictions or incentivize alternative therapies

Implications for Stakeholders

• Manufacturers: Need to demonstrate real-world efficacy and safety, navigate reimbursement pathways.
• Payers: Consider cost-effectiveness, especially as alternatives to stimulants.
• Clinicians: Evaluate clinical data, monitor long-term safety.
• Patients: Prefer treatments with favorable safety profile and minimal stigma.

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Deep Dive: Future Market Expansion and Innovation

Potential Indications and Growth Areas

Indication	Rationale	Current Status
Adult ADHD	Larger market, unmet needs for non-stimulants	Clinical trials underway
Major Depressive Disorder	Serotonergic mechanism aligns with antidepressant approaches	Preclinical/early trials
Other Neuropsychiatric Conditions	OCD, anxiety conditions	Investigational

Pipeline Development and Collaborations

• Supernus’s strategic alliances with research institutions.
• Investment in bioinformatics and precision medicine to identify responsive subpopulations.

Innovation in Delivery and Formulation

• Once-daily formulations.
• Digital adherence tools.
• Drug-drug combination therapies.

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Key Takeaways

• Market Position: VIIBRYD has quickly established itself as a promising non-stimulant ADHD medication, capitalizing on safety and tolerability concerns associated with stimulants.
• Growth Drivers: Increasing ADHD prevalence, clinician acceptance, expanding indications, and favorable regulatory decisions propel long-term growth.
• Challenges: Entrenched stimulant market, reimbursement hurdles, and competition from both generics and other non-stimulants.
• Financial Outlook: Expect gradual revenue increases, with potential acceleration following expanded indications and international launches.
• Strategic Recommendations: Focus on clinical trial success for adult ADHD, innovative formulations, and strategic partnerships to maximize market access.

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FAQs

1. What differentiates VIIBRYD from existing ADHD treatments?
   VIIBRYD acts as a selective serotonin reuptake inhibitor, offering a non-stimulant, potentially lower-abuse-risk option, with a favorable safety profile compared to traditional stimulants.

2. What is the projected timeline for VIIBRYD’s market growth?
   While initial sales focus on pediatric ADHD, expansion into adult populations and other indications over the next 3-5 years could significantly elevate revenues.

3. Are there any significant patent protections securing VIIBRYD’s market exclusivity?
   Yes, patents are effective through at least 2035 in the U.S., supporting revenue stability for Supernus.

4. How does reimbursement landscape influence VIIBRYD’s market penetration?
   Favorable payer policies and formulary positioning are critical; ongoing negotiations and evidence generation will determine broader access.

5. What are the long-term safety considerations for VIIBRYD?
   Extensive phase 3 trials have shown tolerability, yet ongoing post-marketing surveillance will clarify long-term safety, especially for extended use and new indications.

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Sources

1. Centers for Disease Control and Prevention (CDC). (2022). ADHD Data.
2. IQVIA. (2022). US Pharmaceutical Market Reports.
3. FDA. (2021). Approval Letter for VIIBRYD.
4. Barkley et al. (2020). "Efficacy of Viloxazine Extended-Release in Pediatric ADHD." Journal of Child Psychology.
5. Supernus Pharmaceuticals. (2022). Annual Report and Clinical Data.

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Disclaimer: The financial projections are estimates based on current market data and are subject to change with market dynamics and regulatory developments.