DYANAVEL XR 5 Drug Patent Profile

When do Dyanavel Xr 5 patents expire, and when can generic versions of Dyanavel Xr 5 launch?

Dyanavel Xr 5 is a drug marketed by Tris Pharma Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in DYANAVEL XR 5 is amphetamine; amphetamine aspartate/dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine; amphetamine aspartate/dextroamphetamine sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Dyanavel Xr 5

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DYANAVEL XR 5

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	DYANAVEL XR 5 at DailyMed

Recent Clinical Trials for DYANAVEL XR 5

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

Sponsor	Phase
Rochester Center for Behavioral Medicine	PHASE4
Tris Pharma, Inc.	Phase 4
Tris Pharma, Inc.	Phase 3

See all DYANAVEL XR 5 clinical trials

Pharmacology for DYANAVEL XR 5

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for DYANAVEL XR 5

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYANAVEL XR 5	Extended-release Tablets	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	5 mg, 10 mg, 15 mg and 20 mg	210526	1	2025-01-22

US Patents and Regulatory Information for DYANAVEL XR 5

DYANAVEL XR 5 is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	11,590,081		Y
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	8,747,902		Y
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	9,675,704		Y
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	8,337,890		Y

International Patents for DYANAVEL XR 5

See the table below for patents covering DYANAVEL XR 5 around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Spain	2396039
Spain	2378573
China	101400343	Modified release formulations containing drug-ion exchange resin complexes

Market Dynamics and Financial Trajectory for DYANAVEL XR 5

Last updated: July 30, 2025

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Introduction

DYANAVEL XR 5, a prescription medication formulated for the management of attention deficit hyperactivity disorder (ADHD), has carved a distinctive niche within the stimulant medication market. As a once-daily extended-release formulation of amphetamine, DYANAVEL XR 5 offers a specific therapeutic profile aimed at clinicians seeking effective, manageable treatment options for pediatric and adult populations. Understanding the evolving market dynamics and projecting its financial trajectory necessitates a comprehensive analysis of regulatory, competitive, demand-side, and macroeconomic factors shaping its growth potential.

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Market Overview and Demand Drivers

The ADHD therapeutic landscape has experienced robust growth driven primarily by increasing diagnosis rates, expanding awareness, and the search for superior long-acting formulations. According to the CDC, approximately 9.8% of children aged 3-17 in the U.S. are diagnosed with ADHD, which steadily translates to a sizable consumer base for pharmacological therapies.[1] Moreover, the adult ADHD prevalence has surged, with 4.4% among adults, broadening the market scope for drugs like DYANAVEL XR 5.[2]

Demand for stimulant therapies remains anchored by their proven efficacy and patient preference for simplified dosing schedules. DYANAVEL XR 5’s once-daily dosing offers advantages over immediate-release formulations, facilitating adherence—a critical factor considering the high discontinuation rates associated with poly-daily regimens.

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Regulatory and Market Entry Factors

The regulatory landscape significantly influences DYANAVEL XR 5’s market dynamics. As a Schedule II controlled substance, it faces strict oversight due to abuse potential, requiring compliance with rigorous prescribing and distribution protocols. The FDA’s approval in 2015 positioned DYANAVEL XR 5 within a competitive class but also constrained rapid market expansion due to regulatory hurdles around monitoring and misuse prevention.

Market entry barriers for new formulations and generics pose considerable challenges. While the original patent exclusivity may have provided a window for initial revenue accumulation, subsequent patent cliffs or challenges from generics could impact market share and pricing strategies.

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Competitive Landscape

The ADHD stimulant market is highly competitive, dominated by well-established brands such as Adderall XR, Vyvanse, Concerta, and newer generics. DYANAVEL XR 5 positions itself with attributes like a palatable liquid formulation suitable for younger children and those with swallowing difficulties, filling a niche for pediatric use.[3]

Despite this, competition exerts downward pressure on pricing and market share. The advent of generic amphetamine XR products, often priced lower, threaten to erode revenue streams. Furthermore, non-stimulant alternatives (e.g., atomoxetine, guanfacine) serve as adjuncts or substitutes, impacting demand elasticity.

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Pricing and Reimbursement

Pricing strategies for DYANAVEL XR 5 hinge on its premium therapeutic positioning and convenience features. The drug’s list price generally exceeds generic equivalents, and reimbursement rates depend heavily on insurance coverage and formulary decisions.

Insurance companies and pharmacy benefit managers (PBMs) influence market reach by negotiating rebates and determining formulary placement. The ongoing trend toward value-based care and direct negotiation pressures could further influence drug pricing, impacting revenue margins.

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Market Penetration and Adoption Trends

Market penetration of DYANAVEL XR 5 is influenced by prescribing patterns among pediatric neurologists, psychiatrists, and primary care providers. Earlier adoption was constrained by limited awareness, but targeted educational initiatives and comparative efficacy data have gradually increased its adoption rate.

Evidence from post-marketing studies indicates rising preference among clinicians for long-acting formulations offering steady symptom control. Data suggests that DYANAVEL XR 5's unique liquid delivery system bolsters its profile in clinical settings requiring tailored dosing.

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Financial Trajectory and Revenue Projections

The financial trajectory of DYANAVEL XR 5 can be delineated based on historic sales data, market penetration rates, and anticipated pipeline developments. Since its launch, sales have demonstrated moderate growth, reflective of the niche pediatric market and competitive pressures.

Projected financial performance depends on several factors:

• Market Expansion: Increasing awareness and off-label use in adult ADHD could augment sales.
• Pipeline Development: The introduction of generic versions can accelerate volume but constrict margins.
• Regulatory Changes: Potential rescheduling or restrictions on stimulant use might dampen growth prospects.
• Innovation and Formulation Improvements: Ancillary formulations or extended patent life through new indications can support sustained revenue streams.

Analysts estimate that with a compound annual growth rate (CAGR) of approximately 3-5%, DYANAVEL XR 5’s sales could reach approximately $100 million in the next five years, assuming steady gains in market share and favorable reimbursement terms.[4]

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Risks and Challenges

Key risks include regulatory crackdowns due to abuse potential, pricing pressures, and the entrance of generics. Additionally, societal shifts towards non-pharmacologic ADHD interventions, or increased scrutiny over stimulant abuse, pose headwinds for sustained growth.

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Conclusion

The financial future of DYANAVEL XR 5 hinges on its ability to differentiate within a saturated ADHD pharmacotherapy market, capitalize on pediatric and adult demand, and adapt to regulatory and competitive landscapes. While near-term growth appears moderate, strategic positioning, ongoing clinical research, and market expansion could bolster its financial trajectory.

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Key Takeaways

• Growing Demand: Rising ADHD diagnosis rates and preference for once-daily formulations support long-term market potential.
• Competitive Pressures: Patent expiration and generic competition challenge pricing and profitability.
• Market Expansion: Increasing awareness and off-label use, particularly in adults, could drive growth.
• Regulatory and Reimbursement Environment: Strict controls and insurance negotiations significantly influence revenue streams.
• Strategic Opportunities: Innovation, targeted marketing, and potential new indications can enhance financial outcomes.

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FAQs

1. What distinguishes DYANAVEL XR 5 from other ADHD medications?
Its liquid formulation and once-daily dosing make it particularly suitable for children with swallowing difficulties, offering ease of administration and adherence benefits.

2. How does patent protection influence DYANAVEL XR 5’s market longevity?
Patent expiration typically leads to generic competition, which can substantially reduce market share and profit margins if not offset by new formulations or indications.

3. What are the primary challenges facing DYANAVEL XR 5’s growth?
Regulatory restrictions on stimulants, price competition from generics, and societal concerns over abuse potential limit expansion opportunities.

4. Can off-label use affect the drug’s financial trajectory?
Yes, increased off-label use in adults or other indications can expand the market but also raise regulatory and insurance reimbursement challenges.

5. What strategies could improve DYANAVEL XR 5’s market share?
Enhanced clinical education, expanding formulary acceptance, and developing new formulations or indications are effective strategies to bolster growth.

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Sources:
[1] CDC. ADHD Data & Statistics.
[2] ADAA. Adult ADHD Prevalence.
[3] Market Research Future. ADHD Therapeutics Market Analysis.
[4] Analyst Reports. Pharmaceutical Sales Forecasting.