DYANAVEL XR Drug Patent Profile

Which patents cover Dyanavel Xr, and what generic alternatives are available?

Dyanavel Xr is a drug marketed by Tris Pharma Inc and is included in two NDAs. There are ten patents protecting this drug.

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

The generic ingredient in DYANAVEL XR 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 15, 2027. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DYANAVEL XR

International Patents:	21
US Patents:	7
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	3
Drug Prices:	Drug price information for DYANAVEL XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DYANAVEL XR
What excipients (inactive ingredients) are in DYANAVEL XR?	DYANAVEL XR excipients list
DailyMed Link:	DYANAVEL XR at DailyMed

See drug prices for DYANAVEL XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DYANAVEL XR

NDA:

208147

Dosage:

SUSPENSION, 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 DYANAVEL XR

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 clinical trials

Pharmacology for DYANAVEL XR

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

US Patents and Regulatory Information for DYANAVEL XR

DYANAVEL XR is protected by seven US patents.

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
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes			Y
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes			Y
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes			Y

International Patents for DYANAVEL XR

When does loss-of-exclusivity occur for DYANAVEL XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Russian Federation

South Korea

Spain

Taiwan

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 DYANAVEL XR around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0709606	suspensão líquida administrável oralmente com características de liberação modificada
European Patent Office	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
South Korea	101495146

Market Dynamics and Financial Trajectory for DYANAVEL XR: An Industry Analysis

Last updated: September 9, 2025

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Introduction

DYANAVEL XR (amphetamine extended-release) is a prescription medication primarily approved for managing Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adult populations. Since its launch, DYANAVEL XR's trajectory within the pharmaceutical landscape reflects a complex interplay of market dynamics, regulatory factors, clinical positioning, and commercial strategies. This analysis examines the evolving market environment and financial outlook for DYANAVEL XR, highlighting key drivers, competitive forces, and future growth potential.

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Market Overview

ADHD Therapeutic Market Landscape

The global ADHD therapeutics market has experienced consistent growth, driven by increased diagnosis rates, heightened awareness, and expanding treatment guidelines. The market is projected to reach approximately USD 15 billion by 2026, with compounded annual growth rates (CAGR) around 6%.[1] Key players include stimulant medications like methylphenidate and amphetamines, alongside non-stimulant options such as atomoxetine.

Positioning of DYANAVEL XR

DYANAVEL XR fits within the stimulant class, offering extended-release (ER) formulation aimed at simplifying dosing regimens. Its particular value proposition lies in its patient-specific pharmacokinetic profile, which aims to reduce peaks and troughs associated with immediate-release formulations and improve compliance.

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Market Dynamics Affecting DYANAVEL XR

Growth Drivers

• Increased Diagnosis and Treatment Adoption: Rising awareness about ADHD, particularly in children, translates into higher prescription rates. According to CDC data, approximately 9.4% of children aged 2-17 are diagnosed with ADHD in the U.S., fostering demand for effective pharmacologic intervention.[2]
• Preference for Extended-Release Formulations: Physicians and patients favor ER formulations like DYANAVEL XR for their convenience, compliance benefits, and consistent symptom control.
• Product Differentiation and Innovation: DYANAVEL XR's unique delivery mechanism and lower abuse potential compared to other stimulants provide competitive advantages.

Market Challenges

• Regulatory and Safety Concerns: The stimulant class faces scrutiny regarding abuse potential and cardiovascular risks. Regulatory agencies, including the FDA, mandate strict labeling and monitoring, which can affect prescribing practices.
• Generic Competition: The patent expiry and subsequent entry of generic formulations pose significant pricing and margin pressures.
• Pricing and Reimbursement Pressures: Payers increasingly demand cost-effective solutions, impacting formularies and coverage decisions for branded drugs like DYANAVEL XR.
• Limited Market Penetration in Non-U.S. Markets: While the U.S. remains the primary revenue driver, international markets exhibit slower adoption due to regulatory hurdles, clinical practice variations, and pricing regulations.

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Financial Trajectory Analysis

Revenue Potential

The revenue trajectory for DYANAVEL XR is intertwined with market penetration, pricing strategies, and regulatory landscape:

• Initial Launch & Market Penetration: Post-launch, initial uptake depended heavily on physician awareness campaigns and formulary placements. Early sales likely faced hurdles typical of niche stimulant products.
• Current Revenue Performance: As of recent reports, DYANAVEL XR has exhibited steady growth, primarily within the pediatric demographic in the U.S., with revenues estimated to reach hundreds of millions annually.[3]
• Future Revenue Outlook: With expanding awareness and potential indications (e.g., adult ADHD), revenues could grow compounded at a low-double-digit CAGR over the next 5 years, contingent on competitive dynamics and market acceptance.

Profitability and Margins

Branded pharmaceutical products like DYANAVEL XR often enjoy higher profit margins initially but face diminishing returns as generics erode exclusivity:

• Gross Margins: Expected to hover around 60-70%, typical of branded stimulant drugs.
• Net Margins: Influenced by R&D investments, promotional expenses, and negotiations with payers; estimates suggest margins in the 20-30% range in mature phases.
• Impact of Patent and Patent Challenges: The expiration of patent protections could compress margins significantly unless the company innovates with new formulations or indications.

Investment and R&D Considerations

Continued investment in formulation improvements, new indication studies, and combination therapies could bolster financial returns and extend product lifecycle—key factors for sustained growth.

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Competitive and Regulatory Environment

Competitive Dynamics

DYANAVEL XR faces competition from both branded stimulants such as Adderall XR and Vyvanse, and non-stimulant therapies. Differentiation hinges on pharmacokinetic profile, safety profile, and formulary positioning.

Regulatory Landscape

The stimulant class remains under rigorous oversight due to abuse potential. The rescheduling and tighter labeling impact prescribing patterns. Nonetheless, regulatory approval for subsidiaries or expanded indications could enhance the product’s market presence.

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Future Outlook and Strategic Implications

Looking ahead, DYANAVEL XR’s financial trajectory depends on several strategic levers:

• Market Expansion: Penetration of international markets remains promising, especially in Europe and Asia, where ADHD diagnosis is increasing.
• Product Lifecycle Management: Launching new formulations with improved abuse-deterrent features or additional indications could extend profitability.
• Reimbursement Strategies: Securing favorable formulary placements and reimbursement policies will be critical amid payer pressure.

If current trends sustain, DYANAVEL XR’s revenues could stabilize or grow modestly, supported by strategic initiatives and evolving demand for stimulant therapies.

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Key Takeaways

• DYANAVEL XR operates within a growing ADHD market driven by increased diagnosis and patient preference for extended-release stimulants.
• Market growth is constrained by regulatory scrutiny, generic competition, and pricing pressures but remains buoyed by product differentiation.
• Current revenues suggest a stable but gradual upward trajectory, contingent on successful market penetration and strategic innovation.
• Future growth hinges on expanding indications, geographic diversification, and differentiation through formulation improvements.
• Ongoing regulatory oversight underscores the need for compliance and adaptive strategies to sustain profitability.

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FAQs

1. What factors influence the market adoption of DYANAVEL XR?
Market adoption depends on physician familiarity, formulary positioning, patient preferences, regulatory approval, and competition from other stimulant or non-stimulant therapies.

2. How does patent expiry impact DYANAVEL XR’s financial outlook?
Patent expiration typically leads to increased generic competition, reducing prices and profit margins, and challenging revenue growth unless offset by indications expansion or formulation innovations.

3. Can DYANAVEL XR expand into international markets?
Yes, driver for growth. International expansion faces regulatory hurdles and market-specific clinical practices but offers substantial upside given rising ADHD awareness and diagnosis worldwide.

4. How do regulatory changes affect DYANAVEL XR’s profitability?
Enhanced regulations and scheduling can limit prescribing, increase compliance costs, and influence pricing strategies, impacting overall profitability.

5. What strategic initiatives could prolong DYANAVEL XR’s market viability?
Developing new formulations with abuse-deterrent features, gaining approval for additional indications, and entering emerging markets could ensure sustained financial performance.

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References

1. Grand View Research. ADHD Therapeutics Market Size, Share & Trends Analysis Report. 2021.
2. Centers for Disease Control and Prevention (CDC). Data & Statistics on ADHD. 2022.
3. IQVIA. Pharmaceutical Market Data. 2022.

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Disclaimer: This analysis is for informational purposes, reflecting current market data and trends. It does not constitute investment advice.