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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 four patents protecting this drug.

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

Indicators of Generic Entry

Summary for DYANAVEL XR 5

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	DYANAVEL XR 5 at DailyMed

Recent Clinical Trials for DYANAVEL XR 5

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
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

US Patents and Regulatory Information for DYANAVEL XR 5

DYANAVEL XR 5 is protected by four 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	8,747,902		Y
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

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
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)
Denmark	2428205
Brazil	PI0709606	formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica

DYANAVEL XR 5 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of DYANAVEL XR

Introduction to DYANAVEL XR

DYANAVEL XR, developed by Tris Pharma, is an extended-release amphetamine tablet approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. This medication is part of a broader portfolio of ADHD treatments and has been designed to offer a convenient once-daily dosing option.

Market Context of ADHD Treatments

The ADHD market is significant and growing. As of 2022, the ADHD market saw 90 million prescriptions, with a 9% growth compared to 2021[1].

Patient Switching and Market Share

DYANAVEL XR has attracted patients switching from other ADHD medications. A notable 65% of patients who switched to Qelbree (another ADHD medication, though not directly related to DYANAVEL XR) came from stimulants, indicating a potential market for DYANAVEL XR among those seeking alternative treatments. Specifically, for DYANAVEL XR, patients can switch from the oral suspension to the tablet form at an equivalent daily dose, enhancing its market appeal[2][4].

Clinical Efficacy and Safety

The efficacy of DYANAVEL XR tablets has been demonstrated through several clinical studies. A Phase 3, randomized, double-blind, placebo-controlled study in adults with ADHD showed statistically significant improvements in attention as measured by the Permanent Product Measure of Performance Total (PERMP-T) scores. The study highlighted that DYANAVEL XR tablets are effective and well-tolerated, with benefits seen as early as 30 minutes after administration and lasting up to 13 hours post-dose[3][4].

Unique Technology and Dosing Options

DYANAVEL XR employs Tris Pharma's unique LiquiXR® technology, which allows for both immediate-release and extended-release characteristics, enabling once-daily dosing. This technology and the availability of multiple dosage strengths, including a functionally-scored tablet, provide healthcare professionals with flexible dosing and titration options[3][4].

FDA Approval and Regulatory Considerations

The FDA approved DYANAVEL XR tablets in 2021, following a 505(b)(2) NDA submission that demonstrated bioequivalence to the existing DYANAVEL XR oral suspension. However, the approval was contingent on resolving outstanding compliance issues at the manufacturing site. Additional post-marketing studies are required to assess the safety and efficacy in pediatric patients aged 4-5 years[2][4].

Financial Trajectory

Revenue Growth and Portfolio Impact

The introduction of DYANAVEL XR tablets has expanded Tris Pharma's ADHD portfolio, contributing to the company's revenue growth. While specific revenue figures for DYANAVEL XR are not isolated, the overall ADHD market growth and the company's diversified CNS portfolio suggest a positive financial trajectory. Supernus Pharmaceuticals, which has a similar focus on CNS treatments, has shown significant revenue growth over the years, indicating the potential for similar success with DYANAVEL XR[1].

Operating Expenses and Profitability

Tris Pharma's financial performance is influenced by its research and development (R&D) and selling, general, and administrative (SG&A) expenses. For companies like Supernus Pharmaceuticals, which operate in a similar space, combined R&D and SG&A expenses can range from $450 to $480 million, with operating losses adjusted for non-GAAP measures showing a range of $75 to $100 million in operating earnings. While specific figures for Tris Pharma are not provided, the approval and launch of DYANAVEL XR tablets are expected to contribute positively to the company's financial health[1].

Market Penetration and Patient Access

DYANAVEL XR tablets were expected to be stocked in pharmacies in the first quarter of 2022, enhancing patient access. The convenience of a once-daily tablet formulation, combined with the established efficacy of the oral suspension, is likely to increase market penetration. Given that nearly 10 million adults in the U.S. have ADHD, with over 90% of cases untreated, there is a significant unmet need that DYANAVEL XR can address[4].

Competitive Landscape

The ADHD market is competitive, with various stimulant and non-stimulant medications available. However, DYANAVEL XR's unique dosing profile and the flexibility offered by the LiquiXR® technology position it favorably. The ability to switch patients from the oral suspension to the tablet form without changing the dose adds to its competitive advantage[2][4].

Key Takeaways

• Clinical Efficacy: DYANAVEL XR tablets have demonstrated efficacy and safety in treating ADHD in both pediatric and adult populations.
• Market Appeal: The convenience of once-daily dosing and multiple dosage strengths enhance its market appeal.
• Regulatory Approval: FDA approval was granted in 2021, with conditions for post-marketing studies.
• Financial Impact: The launch of DYANAVEL XR tablets is expected to contribute positively to Tris Pharma's revenue and financial health.
• Market Penetration: Expected to increase patient access and market penetration due to its convenient formulation.

FAQs

Q: What is DYANAVEL XR, and how is it used? A: DYANAVEL XR is an extended-release amphetamine tablet used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. It is taken once daily in the morning.

Q: What technology does DYANAVEL XR employ? A: DYANAVEL XR uses Tris Pharma's unique LiquiXR® technology, which allows for both immediate-release and extended-release characteristics.

Q: What were the key findings of the clinical studies for DYANAVEL XR? A: Clinical studies showed statistically significant improvements in attention as measured by the PERMP-T scores, with benefits seen as early as 30 minutes after administration and lasting up to 13 hours post-dose.

Q: How does DYANAVEL XR fit into the broader ADHD market? A: DYANAVEL XR addresses a significant unmet need in the ADHD market, particularly among adults, with nearly 10 million adults in the U.S. having ADHD and over 90% of cases untreated.

Q: What are the common adverse reactions associated with DYANAVEL XR? A: Common adverse reactions include insomnia, dry mouth, headache, irritability, nausea, dizziness, initial insomnia, and tachycardia, most of which are mild to moderate in severity.

Sources

1. Supernus Pharmaceuticals: [Supernus Pharmaceuticals 2023 Report][1]
2. FDA: [NDA 210526 Dyanavel XR (Amphetamine Extended-Release Tablets)][2]
3. Tris Pharma: [Tris Pharma Announces Publication of Study Results Highlighting the Efficacy and Safety of DYANAVEL XR Tablets][3]
4. Tris Pharma: [Tris Pharma Announces FDA Approval of DYANAVEL XR (amphetamine) Once-Daily Extended-Release Oral Tablets, CII, for ADHD][4]