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 five 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:	5
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 five 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	8,337,890		Y
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	12,458,592
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	8,747,902		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)
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)
Austria	E536867
Russian Federation	2435569	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN)
Denmark	2018160
World Intellectual Property Organization (WIPO)	2007109104
Canada	2645855	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)

Market Dynamics and Financial Trajectory for DYANAVEL XR 5

Last updated: February 20, 2026

What Is DYANAVEL XR 5 and Its Approved Indication?

DYANAVEL XR 5 is a prescription medication containing 5 mg of dexmethylphenidate, classified as a central nervous system stimulant. It is approved by the Food and Drug Administration (FDA) for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 and older, adolescents, and adults. The drug is available as an extended-release formulation.

Market Position and Competitive Landscape

Key Competitors

• Concerta (methylphenidate ER): Market leader in ADHD formulations, with a 15-year presence. U.S. sales estimated at $867 million in 2022 [1].
• Vyvanse (lisdexamfetamine): Known for preferred dosing and novel formulation, with U.S. sales at approximately $3.1 billion in 2022 [2].
• Adderall XR (amphetamine/dextroamphetamine ER): Major competitor with over $2 billion in U.S. sales for extended-release formulations in 2022 [3].

DYANAVEL XR 5 Position

• Introduced by Supernus Pharmaceuticals in 2017.
• Differentiates through rapid onset and convenience via once-daily dosing.
• Market share remains limited, estimated at around 2-3% of ADHD pharmaceutical sales within five years of launch.

Patent and Exclusivity Status

• Patent protection expected expiry in 2024 [4].
• No additional exclusivity anticipated beyond patent expiration.

Market Drivers

Growing ADHD Prevalence

• Prevalence rates in the U.S. are approximately 9.4% among children aged 3–17 [5].
• Adult diagnosis rates rising, increasing demand for stimulant medications.

Formulation Preferences

• Extended-release formulations favored for compliance.
• Growing preference for medications with rapid onset and consistent plasma levels.

Healthcare Access and Prescriber Trends

• Insurance coverage for ADHD medications steady.
• Pediatric and adult psychiatrists increasingly prescribing newer formulations.

Price and Reimbursement Landscape

• Average retail price (ARP) for DYANAVEL XR 5: approximately $250 per month [6].
• Reimbursement varies, but favorable formulary placement can influence sales.

Financial Trajectory and Revenue Outlook

Historical Sales Data

• Estimated U.S. sales were approximately $30–40 million in 2022.
• Growth has remained modest due to limited market share and competition.

Projections Post-Patent Expiry (2024)

Year	Estimated U.S. Sales	Key Drivers
2023	$35 million	Market penetration, physician awareness
2024	$10 million (due to patent loss)	Patent expiry, generic competition introduction
2025	$15–20 million	Transition period, generic uptake
2026+	<$10 million	Market saturation, formulary exclusion

Factors Impacting Future Revenue

• Generic Entry: Expected significant price erosion after patent expiry.
• Formulary Decisions: Inclusion or exclusion affecting prescriptions.
• Competition: Markt dominance of long-established brands may limit growth.
• Pipeline Developments: No current indications for expanded uses or formulations.

Regulatory and Reimbursement Considerations

• Potential for biosimilar or generic versions post-2024.
• Medicaid and Medicare policies favor cost-effective generics.
• Pricing pressures from payers may reduce margins.

Investment and R&D Outlook

• Supernus has limited pipeline activity targeting ADHD beyond DYANAVEL XR.
• Focus remains on maximizing the current product lifecycle before patent expiry.

Key Takeaways

• DYANAVEL XR 5 is a niche player within a mature ADHD market.
• Revenue growth remains constrained; sustainability hinges on patent exclusivity and clinical differentiation.
• Market dynamics suggest a sharp decline in sales post-2024 due to the impending patent expiration.
• Competitive pressure from well-established brands and generics is likely to erode market share rapidly.
• Long-term profitability depends on pipeline development or diversification strategies.

FAQs

1. How does DYANAVEL XR 5 compare to other ADHD medications?

It offers rapid onset and once-daily dosing but has a smaller market share due to intense competition from longer-established brands like Concerta, Vyvanse, and Adderall XR.

2. What is the impact of patent expiration for DYANAVEL XR 5?

Patent expiry in 2024 will enable generic versions, leading to significant price declines and volume reductions, reducing revenues markedly.

3. Can DYANAVEL XR 5 expand into adult ADHD treatment?

Potential exists, but prescribing patterns and formulary access in adults limit growth. No new indications are currently approved.

4. What are the key risks for DYANAVEL XR’s future sales?

Patent expiry, generic competition, formulary exclusions, and shifting prescribing preferences pose major risks.

5. Will biosimilars or generics significantly impact the market?

Yes. Post-2024, generics are expected to dominate sales, leading to price erosion and increased market share for competitors.

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References

[1] IQVIA. (2023). IQVIA National Sales Perspective.

[2] EvaluatePharma. (2022). Global sales data for Vyvanse.

[3] PhRMA. (2022). Annual Report on ADHD clinicians and prescribing trends.

[4] FDA. (2022). Patent information for DYANAVEL XR.

[5] Centers for Disease Control and Prevention. (2022). ADHD prevalence estimates.

[6] GoodRx. (2023). Average retail prices for ADHD medications.