DYANAVEL XR 10 Drug Patent Profile

Which patents cover Dyanavel Xr 10, and when can generic versions of Dyanavel Xr 10 launch?

Dyanavel Xr 10 is a drug marketed by Tris Pharma Inc and is included in one NDA. There are four patents protecting this drug.

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

The generic ingredient in DYANAVEL XR 10 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 10

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.

Indicators of Generic Entry

Summary for DYANAVEL XR 10

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	DYANAVEL XR 10 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DYANAVEL XR 10

Constraining patent/regulatory exclusivity:

8,337,890

NDA:

210526

Dosage:

TABLET, 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 10

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 10 clinical trials

Pharmacology for DYANAVEL XR 10

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

US Patents and Regulatory Information for DYANAVEL XR 10

DYANAVEL XR 10 is protected by four US patents.

This potential generic entry date is based on patent 8,337,890.

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 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	11,590,081		Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	9,675,704		Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	8,337,890		Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No	8,747,902		Y

International Patents for DYANAVEL XR 10

See the table below for patents covering DYANAVEL XR 10 around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101495146
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)
Australia	2007227569	Modified release formulations containing drug-ion exchange resin complexes
Spain	2378573

Market Dynamics and Financial Trajectory for DYANAVEL XR 10

Last updated: July 28, 2025

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Introduction

DYANAVEL XR 10, a prescription medication extensively used in managing Attention Deficit Hyperactivity Disorder (ADHD), has carved a notable position within the psychiatric pharmacotherapy segment. Manufactured by Tris Pharma Inc., DYANAVEL XR 10 is an extended-release oral formulation of amphetamine. As the pharmaceutical landscape evolves alongside heightened ADHD awareness, there is increased focus on the market dynamics, competitive environment, and revenue prospects associated with DYANAVEL XR 10. An understanding of these factors is pivotal for stakeholders including investors, healthcare providers, and strategic partners aiming to optimize their positioning in this niche.

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Market Overview

ADHD prevalence and treatment landscape

The global ADHD market is expanding rapidly, underpinned by rising diagnosed prevalence and socio-economic factors. According to the World Health Organization (WHO), approximately 5% of children globally are diagnosed with ADHD, with similar prevalence in adults. North America, especially the United States, remains the dominant market due to higher diagnosis rates and extensive healthcare access.[1]

Stimulant medications such as methylphenidate and amphetamines constitute the primary treatment modality. DYANAVEL XR 10, leveraging its extended-release profile, targets patients requiring sustained symptom control with fewer doses, appealing to both prescribers and patients.

Product positioning

DYANAVEL XR 10 differentiates itself with its once-daily extended-release mechanism, providing consistent symptom management across the day. Its flexible dosing options and quick onset contribute to its adoption within pediatric and adult ADHD populations.

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Market Dynamics

Competitive landscape

The ADHD pharmaceutical market is crowded, with major contenders including Vyvanse (lisdexamfetamine), Adderall XR (mixed amphetamine salts), and Concerta (methylphenidate ER). DYANAVEL XR 10's key advantages are its unique pharmacokinetic profile and delivery system. However, its market share faces challenges from established medications with broad prescriber familiarity.

Innovative formulations and patent landscapes influence DYANAVEL XR 10's positioning. Patents protecting its extended-release technology are critical for exclusivity, yet looming patent expirations could invite generic competition. The introduction of biosimilars or bioequivalent generics would significantly impact revenue streams.

Regulatory environment and approvals

The Food and Drug Administration (FDA) approval for DYANAVEL XR 10 assures compliance with safety and efficacy standards, facilitating market entry. Any future regulatory modifications concerning stimulant use or abuse deterrence could shift market dynamics.

Prescription trends

Over the past five years, prescription volumes for ADHD medications, including DYANAVEL XR 10, have increased steadily, driven by heightened awareness, better diagnosis, and expanded treatment guidelines.[2] Providers favor medications offering flexible dosing and minimal abuse potential.

The COVID-19 pandemic has temporarily affected prescription patterns, with telemedicine facilitating continued access. Post-pandemic behaviors are anticipated to normalize, potentially stabilizing or boosting demand.

Pricing and reimbursement

Pricing strategies directly influence market penetration. DYANAVEL XR 10, positioned as a premium therapy, must navigate insurance reimbursement protocols. Reimbursement rates, prior authorization hurdles, and formulary placements can either accelerate or hinder access, thus affecting sales trajectories.

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Financial Trajectory

Revenue projections

Currently, DYANAVEL XR 10's revenues are modest compared to market giants like Vyvanse and Adderall XR, but it benefits from niche positioning and specialty pharmacy channels. As prescriber familiarity increases, sales could experience compound annual growth rates (CAGR) estimated between 10-15% over the next five years.

A detailed analysis indicates that initial sales have primarily been driven by early adopters, with growth migrating into broader markets due to:

• Expansion into adult ADHD prescriptions.
• Increased pediatric use.
• Potential indications beyond ADHD, such as narcolepsy or treatment-resistant depression (if supported by clinical evidence).

Market penetration strategies

To enhance financial outcomes, Tris Pharma Inc. might invest in:

• KOL engagement to boost prescriber confidence.
• Educational campaigns targeting clinicians and patients.
• Strategic pricing models balancing profitability and access.
• Expanding distribution channels, including formulary inclusions.

Impact of patent and generics

Patent expiry within the next 3-5 years could lead to significant revenue erosion via generics. The entrance of generic amphetamine XR formulations will intensify price competition, necessitating differentiation strategies for DYANAVEL XR 10 to sustain margins.

Potential pipeline and indications

Exploring additional indications and formulation improvements could provide new revenue streams. For instance, developing formulations with abuse-deterrent properties or extending label indications can bolster long-term financial stability.

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Key Market Risks and Opportunities

Risks:

• Market entry of generic competitors post-patent expiration.
• Regulatory reforms limiting stimulant prescribing.
• Shifts in prescribing preferences favoring non-stimulant therapies.
• Increasing regulatory scrutiny over abuse potential and schedule classification.

Opportunities:

• Growing awareness and diagnosis of adult ADHD.
• Expansion into emerging markets with increasing pharmaceutical penetration.
• Development of combination therapies or novel delivery systems.
• Strategic alliances with payers to secure favorable formulary positioning.

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Future Outlook and Strategic Recommendations

The future of DYANAVEL XR 10 hinges on ongoing innovation, market penetration, and navigating patent landscapes. To maximize its financial trajectory:

• Invest in clinical trials to expand indications.
• Enhance marketing efforts emphasizing unique benefits.
• Engage with regulators and payers early to streamline approval and reimbursement pathways.
• Monitor competitors and adjust strategies accordingly.

In sum, while facing foreseeable patent cliff challenges, DYANAVEL XR 10’s adaptive strategies can sustain its growth and profitability, especially with the expanding ADHD population and the rising demand for extended-release formulations.

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Key Takeaways

• Demand growth driven by rising ADHD diagnoses, especially in adults, positions DYANAVEL XR 10 favorably for future sales increments.
• Competitive environment demands differentiation, particularly as patent expirations threaten market share.
• Pricing and reimbursement strategies are pivotal; optimizing formulary access can significantly influence revenue.
• Pipeline expansion and indication diversification could mitigate patent risk and open new markets.
• Strategic innovation in delivery systems and abuse-deterrent features will be vital to sustain market relevance.

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FAQs

1. How does DYANAVEL XR 10 differ from other ADHD medications?
DYANAVEL XR 10 offers extended, smooth symptom control through its unique delivery system, enabling once-daily dosing with rapid onset, appealing to both pediatric and adult populations.

2. What is the projected impact of generic competition on DYANAVEL XR 10?
Post-patent expiration, generic amphetamine XR formulations will likely reduce DYANAVEL XR 10's market share and margins unless differentiated through formulation or added value features.

3. Are there expansion opportunities beyond ADHD for DYANAVEL XR 10?
Potential exists in expanding to indications such as narcolepsy or treatment-resistant depression, provided clinical trials support such uses, which could diversify revenue streams.

4. What strategies can sustain DYANAVEL XR 10’s market position amid competitive pressures?
Investment in clinical research, strengthening prescriber relationships, optimizing pricing, and introducing abuse-deterrent technologies are critical.

5. How does reimbursement landscape influence DYANAVEL XR 10’s sales?
Favorable reimbursement and formulary placement directly impact prescription volume, necessitating strategic payer engagement and value demonstration to maximize reimbursement potential.

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Sources

[1] World Health Organization. Global prevalence of ADHD. (2022).
[2] IQVIA Prescription Data. ADHD Medication Trends (2022).