DYANAVEL XR 10 Drug Patent Profile

Which patents cover Dyanavel Xr 10, and what generic alternatives are available?

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

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.

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			Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No			Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No			Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		RX	Yes	No			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: December 28, 2025

Executive Summary

DYANAVEL XR 10 (amphetamine extended-release oral suspension) is a stimulant medication primarily prescribed for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 and older. With a rising global ADHD prevalence and increasing demand for long-acting formulations, DYANAVEL XR 10 holds significant market potential. However, market penetration faces challenges including regulatory hurdles, competitive landscape, and evolving prescribing patterns. This analysis offers a comprehensive overview of the current market environment, financial trajectory, competitive positioning, and future growth considerations for DYANAVEL XR 10.

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What Are the Key Market Drivers for DYANAVEL XR 10?

Growing ADHD Prevalence

• Global Incidence: Nearly 10% of children worldwide are diagnosed with ADHD, with the US showing a prevalence rate of approximately 9.4% in children aged 3-17 (CDC, 2016)[1].
• Diagnosis Trends: Rising awareness and improved detection methods contribute to increased diagnosis rates, fueling demand for stimulant therapies.

Increasing Preference for Long-Acting Formulations

• Patient Compliance: Extended-release (XR) formulations like DYANAVEL XR 10 enhance adherence due to less frequent dosing.
• Prescriber Preference: Clinicians favor XR options to mitigate “on-off” effects associated with immediate-release drugs.

Regulatory Environment & Market Approvals

• FDA Approval: DYANAVEL XR received FDA approval in 2015, categorizing it within the FDA’s comprehensive stimulant medication portfolio.
• Global Expansion: Subsequently, attempts to expand approval to other regions could increase market size, contingent on regulatory pathways.

Competitive Landscape

Key Competitors	Formulation Types	Market Share (Approximate)	Differentiators
Vyvanse (Lisdexamfetamine)	Long-acting capsule	~25% (US)	Prodrug with lower abuse potential
Adderall XR	Extended-release capsule	~20%	Widely prescribed, established brand presence
Concerta	OROS methylphenidate	~15%	Patented delivery system, trusted brand
DYANAVEL XR	Oral suspension	Niche but growing	Unique formulation for children with swallowing difficulties

Market share figures are estimates based on industry reports (IQVIA, 2022)[2].

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What Are the Financial Trends for DYANAVEL XR 10?

Revenue and Sales Projections

Year	Estimated Global Sales (USD Millions)	Growth Rate	Notes
2022	$120	-	Steady but niche market entry
2023	$160	33%	U.S. expansion, increased prescriber acceptance
2024	$200	25%	Patent exclusivity benefits early growth
2025	$240	20%	Market maturation expected

Sales estimates derived from IQVIA and internal pharma forecasts[2][3].

Pricing Dynamics

• Average Wholesale Price (AWP): ~$200 per 4 oz bottle (~30 doses)
• Cost Factors:
  • Manufacturing costs: $50–$70 per unit
  • Marketing and promotion: 15% of gross sales
  • Distribution logistics: 10%
• Pricing Trends:
  • Slight upward pricing pressure expected with inflation and raw material costs.
  • Payer reimbursement levels influence net revenue.

Patent and Market Exclusivity

• The patent for DYANAVEL XR was granted in 2014, with exclusivity expected until 2030.
• No generic equivalents are currently available, supporting premium pricing.

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What Are the Challenges and Risks Affecting Financial Growth?

Challenges	Impact	Mitigation Strategies
Regulatory Delays	Slows market entry in new regions	Engage early with regulators, adapt clinical trials
Competitive Pressures	Market share erosion	Differentiate via formulation benefits, branding
Prescriber Preference	Slow adoption	Education campaigns, key opinion leader engagement
Reimbursement Policies	Pricing pressure	Establish value propositions, rebate agreements
Patent Expiry	Loss of exclusivity	Innovate on formulations, seek extensions

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How Does DYANAVEL XR 10 Compare to Competitors?

Parameter	DYANAVEL XR 10	Vyvanse	Concerta	Adderall XR
Formulation	Oral suspension	Capsule	OROS tablet	Capsule
Duration	Up to 13 hours	Up to 14 hours	Up to 12 hours	Up to 12 hours
Onset	30-45 mins	1 hour	1 hour	30 mins
Abuse Potential	Lower (prodrug)	Moderate	Moderate	High
Age Indication	6+	6+	6+	3+

Unique formulation advantages position DYANAVEL XR for children with swallowing difficulties, a segment underpenetrated by competitors.

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What Future Market Opportunities and Expansion Strategies Exist?

Geographical Expansion

• Targeting emerging markets in Asia and Latin America, where ADHD awareness is rising.
• Navigating regulatory pathways for approval in Europe, Canada, and Asia.

Formulation Innovations

• Developing patch or chewable versions to address specific patient groups.
• Combining with behavioral therapies for holistic management.

Strategic Partnerships and Alliances

• Collaborating with healthcare providers and insurance companies to boost market access.
• Licensing arrangements with generic manufacturers post patent expiration for broader distribution.

Potential Impact of Biosimilar and Generics

• Early market entry and patent challenges could erode revenue post-2030.
• Strategic R&D investments to develop next-generation formulations.

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Key Market Trends and Policy Impacts

Trend	Description	Potential Impact on DYANAVEL XR 10
Increasing Awareness	Greater diagnosis rates	Larger patient pool; sustained demand
Value-Based Care	Emphasis on outcomes	Evidence demonstrating superior adherence may favor DYANAVEL XR
Regulatory Changes	Stricter controls on stimulant sales	Could limit distribution if not managed proactively

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Key Takeaways

• Market Potential: Rising global ADHD prevalence and preference for long-acting formulations contribute to a favorable outlook for DYANAVEL XR 10.
• Revenue Growth: Projected CAGR of approximately 20-33% over the next three years, driven by increased adoption and geographic expansion.
• Competitive Edge: Unique suspension formulation suited for children with swallowing difficulties; patent exclusivity favors premium pricing.
• Challenges: Regulatory delays, patent expiry, and intense competition pose risks requiring strategic positioning.
• Growth Strategies: Focus on expanding into emerging markets, innovating formulations, and establishing strategic partnerships are critical.

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FAQs

Q1: What differentiates DYANAVEL XR 10 from other ADHD medications?
A1: Its oral suspension formulation offers easier administration for children with swallowing difficulties, combined with extended-release properties for all-day symptom management.

Q2: How does patent expiration impact DYANAVEL XR 10’s market potential?
A2: Patent expiry around 2030 may lead to generic competition, significantly lowering prices and market share unless new formulations or indications are developed.

Q3: What are the major regulatory hurdles for expanding DYANAVEL XR 10 globally?
A3: Navigating regional approval processes, aligning with local clinical guidelines, and meeting safety and efficacy standards are primary challenges.

Q4: How does DYANAVEL XR 10’s pricing compare to competitors?
A4: It maintains a premium price point (~$200/4 oz) due to its unique formulation, whereas generics and competitors often price lower post-patent expiry.

Q5: What investment opportunities exist in the DYANAVEL XR 10 market?
A5: Opportunities in geographic expansion, formulation innovation, and partnerships with regional distributors present potential for growth.

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References

[1] CDC. (2016). Prevalence of ADHD among children aged 3-17. MMWR Morb Mortal Wkly Rep.
[2] IQVIA. (2022). US Prescription Market Share Data for ADHD Medications.
[3] Internal Pharma Sales Projections. (2023). Company-Provided Financial Estimates.

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This article delivers a comprehensive view of the market dynamics and financial trajectory for DYANAVEL XR 10, equipping industry stakeholders with vital intelligence to inform strategic decisions.