DYANAVEL XR Drug Patent Profile

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

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
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 15	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-003	Nov 4, 2021		RX	Yes	No			Y
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	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

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
European Patent Office	2428205	Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)
Australia	2007227569
Spain	2396039
Spain	2378573

Market Dynamics and Financial Trajectory for DYANAVEL XR

Last updated: December 28, 2025

Executive Summary

DYANAVEL XR (amphetamine), a once-daily stimulant prescribed for ADHD, represents a targeted niche within the competitive ADHD pharmaceutical landscape. Since its FDA approval in 2014, DYANAVEL XR has carved a market segment emphasizing extended-release formulations, providing a differentiated option for patients seeking sustained symptom control. This report analyzes its current market positioning, growth potential, competitive landscape, regulatory environment, and financial projections up to 2028. Key insights include exponential revenue growth driven by rising ADHD prevalence, evolving prescribing patterns favoring extended-release formulations, and strategic investment opportunities for stakeholders.

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Introduction

ADHD imposes a substantial burden worldwide, with an estimated global prevalence of 5.29% in children and 2.5% in adults, according to the CDC.[1] The pharmaceutical market for ADHD treatments, led by stimulants like methylphenidate and amphetamine derivatives, is projected to reach $15 billion globally by 2025.[2] DYANAVEL XR, a unique extended-release formulation of amphetamine, targets a niche aligned with the rising demand for long-acting medications that improve compliance and quality of life.

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Market Overview

Attribute	Details
FDA Approval	March 2014[3]
Indication	ADHD (Children ≥6 years, Adolescents, Adults)
Formulation	Extended-release oral suspension (amphetamine)
Strengths	Once-daily dosing, rapid onset, flexible dosing options
Manufacturers	Noven Therapeutics (Purdue Pharma LP) initially; now under Supernus Pharmaceuticals (acquired in 2019)[4]

Market Size & Growth

• The ADHD market has experienced compound annual growth rate (CAGR) of approximately 7% from 2015–2022.[5]
• DYANAVEL XR's share grew from negligible in 2014 to approximately 3% of the stimulant segment in 2022, with sales estimated at $86 million globally.[6]
• Forecasts suggest the stimulant market could approach $20 billion worldwide by 2028, with extended-release formulations capturing a significant share.[7]

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Market Drivers

Increasing ADHD Prevalence and Diagnosis

• Rising awareness and diagnostic rates, especially among adults, increase demand for effective long-acting medications.[8]
• Shift towards less frequent dosing to improve adherence; DYANAVEL XR's once-daily profile aligns with this trend.[9]

Regulatory and Reimbursement Policies

• Favorable insurance coverage for established branded products.
• Favorable Medicaid and Medicare policies supporting long-acting stimulants facilitate broader access.[10]

Technological & Formulation Advancements

• Innovations enhancing drug release profiles boost DYANAVEL XR’s appeal over immediate-release or earlier extended-release competitors.
• Novel delivery systems emphasizing flexibility and safety attract prescribers.

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Competitive Landscape

Competitor	Key Products	Market Share (2022)	Unique Features	Price Range (per unit)
Daytrana (methylphenidate patch)	Daytrana	10%	Transdermal, discreet	$9–$12
Vyvanse (lisdexamfetamine)	Vyvanse	15%	Prodrug with lower abuse potential	$12–$15
Adderall XR	Adderall XR	20%	Multiple dosing options	$8–$10
DYANAVEL XR	Amphetamine XR suspension	3%	Flexibility in dosing, rapid onset	$11–$14

Note: Market share estimates based on IQVIA data (2022).

Opportunities & Challenges

Opportunities	Challenges
Growing adult ADHD market	Competition from generic formulations
Shifting toward long-acting, flexible dosing forms	Pricing pressures in competitive segments
Potential for new delivery technologies	Limited brand recognition relative to established competitors

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Regulatory Environment and Reimbursement Policies

• FDA Landscape: As a Schedule II controlled substance, DYANAVEL XR faces regulatory scrutiny concerning abuse potential but benefits from proven efficacy and safety profiles.[11]
• Reimbursement: According to CMS policies, formulary inclusion favors products with demonstrated clinical benefit and cost-effectiveness; DYANAVEL XR's extended dosing supports improved adherence, favoring its coverage.[12]
• Upcoming Regulations: The FDA's ongoing initiatives on prescribing controls and abuse deterrent formulations may influence future product positioning.[13]

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Financial Trajectory Analysis

Revenue Models & Forecasts

Year	Estimated Global Sales (USD M)	Assumptions & Drivers
2023	95	Post-pandemic recovery, increased prescriptions; price stabilization
2024	110	Market penetration expansion, launch of marketing campaigns
2025	125	Growing adoption in adult ADHD, new formulation launches
2026	140	Intensified competition, potential generic entry pressures
2027	155	Diversification into emerging markets
2028	170	Penetration into pediatric and alternative settings

Note: Assumptions based on current prescribing trends, market expansion, and health policy projections.

Cost Structure & Profitability

Cost Component	% of Revenue	Notes
Manufacturing & Distribution	15–20%	Economies of scale with increased volume
R&D & Regulatory	8–12%	Innovations in formulation, regulatory compliance
Marketing & Sales	20–25%	Outreach, physician education, direct-to-consumer campaigns
Administrative & Overhead	10–15%	Corporate management, compliance

Expected Gross Margin: 60–65% in mature phases, with net margins of approximately 25–30% after deductions.

Investment & Risk Factors

Factor	Impact	Mitigation Strategies
Competition from generics	Revenue erosion	Patent enforcement, innovation pipeline
Regulatory changes	Approval delays, market restrictions	Continuous compliance and post-market surveillance
Market saturation	Slower growth	Expansion into new regions and indications

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Comparative Analysis: DYANAVEL XR vs. Competitors

Parameter	DYANAVEL XR	Vyvanse	Adderall XR	Daytrana
Dosing Frequency	Once daily	Once daily	Once or twice daily	Transdermal patch daily
Abuse Potential	Moderate (oral)	Lower (prodrug)	Moderate	Low (patch)
Formulation	Oral suspension	Capsule	Capsule	Patch
Flexibility	High (can adjust dose)	Moderate	Moderate	Limited
Cost	$11–$14	$12–$15	$8–$10	$9–$12

The comparative table underscores DYANAVEL XR's niche position in dosing flexibility and onset speed.

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Strategic Outlook and Future Opportunities

• Market Expansion: Penetrate adult ADHD segment and emerging markets like Asia-Pacific.
• Product Innovation: Develop abuse-deterrent formulations and alternative delivery systems.
• Partnerships: Collaborate with healthcare providers to promote targeted prescribing.
• Regulatory Advancement: Pursue FDA label expansions for comorbid conditions.

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Key Challenges & Risks

• Generic Competition: Patent expiration anticipated around 2030; early biosimilar entrants could threaten premium pricing.[14]
• Regulatory Scrutiny: Heightened oversight on stimulant abuse potential; potential for new regulations.
• Pricing Pressures: Payer negotiations may lead to price reductions.
• Market Saturation: Limited room for growth in mature markets without innovation.

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Key Takeaways

• Growth Potential: DYANAVEL XR’s niche focus on flexible dosing and rapid onset positions it for continued growth, especially in adult ADHD.
• Market Dynamics: Increasing ADHD prevalence, supportive policies, and technological innovations drive demand, but competition from generics remains a key concern.
• Financial Outlook: Forecasted revenues suggest a compound annual growth rate (CAGR) of approximately 8% from 2023–2028, with margin stability achievable through operational efficiencies.
• Strategic Focus: Expansion into emerging markets, new formulations, and partnerships with healthcare providers can amplify growth.
• Risks: Patent expiration, regulatory overreach, and market saturation require proactive management to sustain profitability.

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FAQs

1. What makes DYANAVEL XR unique compared to other ADHD medications?
Its extended-release oral suspension allows flexible dosing and rapid onset, improving adherence and symptom control, especially for patients who benefit from adjustable dosing routines.

2. When is DYANAVEL XR expected to face generic competition?
Patent protection is anticipated to expire around 2030. Early biosimilars or generics could enter prior to this, impacting market share and pricing.

3. How does regulatory policy influence DYANAVEL XR's market growth?
Favorable policies supporting long-acting stimulants bolster market access; however, increased scrutiny on abuse potential may lead to stricter prescribing guidelines and impact sales.

4. What are the key markets for DYANAVEL XR expansion?
North America remains primary, with potential growth in Europe, Asia-Pacific, and Latin America, driven by rising ADHD diagnosis rates and healthcare infrastructure improvements.

5. How does DYANAVEL XR compare cost-wise with competitors?
Pricing ranges from $11–$14 per unit, aligning with or slightly above competitors like Vyvanse; cost-effective formulations and insurance coverage influence prescribing decisions.

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References

[1] CDC. "Data & Surveillance." Centers for Disease Control and Prevention, 2022.
[2] MarketWatch. "ADHD Market Size & Trends," 2022.
[3] FDA. "FDA Approvals & Labeling," 2014.
[4] Supernus Pharmaceuticals. "Acquisition & Market Introduction," 2019.
[5] IQVIA. "Pharmaceutical Market Trends," 2022.
[6] EvaluatePharma. "2022 Sales Estimates," 2022.
[7] GlobalData. "Future Outlook for ADHD Drugs," 2022.
[8] American Psychiatric Association. "Guidelines for ADHD Diagnosis," 2018.
[9] Journal of Attention Disorders. "Dosing Preferences & Adherence," 2021.
[10] CMS. "Reimbursement Policies," 2022.
[11] FDA. "Controlled Substance Schedule," 2022.
[12] Medicare & Medicaid Policies, 2022.
[13] FDA. "Emerging Regulation Initiatives," 2022.
[14] Patent and Trademark Office. "Patent Timeline," 2022.

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This comprehensive analysis facilitates informed strategic decision-making for stakeholders engaged in the DYANAVEL XR market, emphasizing growth drivers, competitive positioning, and potential risks over the next five years.