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DYANAVEL XR 10 Drug Patent Profile

When do Dyanavel Xr 10 patents expire, 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:	2
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
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
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
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)

DYANAVEL XR 10 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DYANAVEL XR

Introduction

DYANAVEL XR, an amphetamine extended-release formulation, has been a significant player in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) since its approval by the U.S. Food and Drug Administration (FDA) in 2015. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Positioning

DYANAVEL XR is unique in the ADHD market as it is available in both oral suspension and tablet forms, catering to different patient needs. The oral suspension, approved in 2015, was the first liquid amphetamine formulation on the market, while the extended-release tablets were approved later as a line extension[4].

Patient Demographics

DYANAVEL XR is indicated for patients aged 6 years and older, making it a versatile treatment option for both children and adults. Studies have shown its efficacy in controlling ADHD symptoms in both pediatric and adult populations[2][3][5].

Efficacy and Safety

The efficacy of DYANAVEL XR has been demonstrated through several clinical trials. For children, the medication showed significant improvements in attention and behavior, reducing impulsivity and hyperactivity, with effects lasting up to 13 hours post-dose[3][5]. In adults, DYANAVEL XR tablets also demonstrated statistically significant improvements in ADHD symptoms, with efficacy observed as early as 0.5 hours post-dose and lasting up to 13 hours[2].

Side Effects

Common side effects of DYANAVEL XR include headache, decreased appetite, irritability, and insomnia, which are generally mild to moderate in severity. In pediatric studies, side effects such as nosebleeds, allergic rhinitis, and upper abdominal pain were noted but were comparable to other long-acting amphetamine formulations[3][5].

Market Competition

The ADHD market is highly competitive, with several established brands such as Vyvanse, Adderall XR, and Concerta. However, DYANAVEL XR's unique formulation and pediatric-friendly options have helped it carve out a niche. For instance, Qelbree, another ADHD medication, saw 65% of its patients switching from stimulants like Vyvanse and Adderall XR, indicating a potential market share for DYANAVEL XR among patients seeking alternative treatments[1].

Financial Performance

Tris Pharma, the manufacturer of DYANAVEL XR, has seen significant financial implications from the drug's launch.

Revenue Impact

The introduction of DYANAVEL XR has contributed to Tris Pharma's revenue growth. While specific revenue figures for DYANAVEL XR are not publicly disclosed, the drug's approval and subsequent market performance have been key factors in the company's financial health.

Cost and Pricing

The cost of DYANAVEL XR can vary based on the formulation and dosage. Generally, extended-release ADHD medications are priced competitively, and DYANAVEL XR is no exception. The recommended starting dose of 2.5 mg or 5 mg once daily, with potential increases up to 20 mg, allows for flexible pricing strategies that can appeal to a wide range of patients[4].

Regulatory Environment

The regulatory approval process for DYANAVEL XR has been crucial for its market entry. The FDA approval in 2015 for the oral suspension and later for the extended-release tablets has ensured compliance with stringent safety and efficacy standards. However, regulatory challenges, such as compliance issues at manufacturing sites, have occasionally delayed the approval process[4].

Marketing and Distribution

Tris Pharma has been proactive in marketing and distributing DYANAVEL XR. The company has highlighted the drug's unique features, such as its pediatric-friendly formulation and once-daily dosing, to healthcare providers and patients. This targeted marketing has helped in increasing the drug's visibility and adoption in the market[5].

Future Outlook

The future outlook for DYANAVEL XR is promising, given its established efficacy and safety profile.

Pipeline and Innovations

Tris Pharma continues to innovate, with the LiquiXR® platform technology allowing for the development of new formulations that combine immediate and extended-release characteristics. This technology can further enhance the drug's market position and patient compliance[2].

Market Expansion

As the ADHD market continues to grow, DYANAVEL XR is well-positioned to capture a significant share. The drug's approval for both children and adults, along with its unique formulations, makes it a versatile treatment option that can appeal to a broad patient base.

Key Takeaways

• Efficacy and Safety: DYANAVEL XR has demonstrated significant efficacy in controlling ADHD symptoms in both children and adults, with a safety profile comparable to other long-acting amphetamine formulations.
• Market Positioning: The drug's unique formulations, including oral suspension and extended-release tablets, cater to different patient needs and help it stand out in a competitive market.
• Financial Performance: DYANAVEL XR has contributed to Tris Pharma's revenue growth, although specific figures are not publicly disclosed.
• Regulatory Environment: FDA approvals have been crucial, but compliance issues have occasionally delayed the process.
• Future Outlook: The drug is well-positioned for continued market growth, driven by its innovative formulations and expanding patient base.

FAQs

1. What is DYANAVEL XR used for? DYANAVEL XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.

2. What are the common side effects of DYANAVEL XR? Common side effects include headache, decreased appetite, irritability, and insomnia. In pediatric patients, side effects such as nosebleeds, allergic rhinitis, and upper abdominal pain have been noted.

3. How does DYANAVEL XR differ from other ADHD medications? DYANAVEL XR is unique due to its availability in both oral suspension and extended-release tablet forms, making it a pediatric-friendly option. It also employs Tris Pharma's LiquiXR® platform technology.

4. What is the recommended dosing for DYANAVEL XR? The recommended starting dose is 2.5 mg or 5 mg once daily in the morning, with potential increases up to 20 mg per day if needed.

5. Has DYANAVEL XR been approved for use in adults? Yes, DYANAVEL XR has been approved for use in adults and has demonstrated efficacy in controlling ADHD symptoms in this population.

Sources

1. Supernus Pharmaceuticals - Year-end 2018 inventory build by distribution channel increased 2018 net sales by approximately $10 million and negatively impacted 2019 net sales.
2. Tris Pharma Announces Publication of Study Results - Highlighting the efficacy and safety of DYANAVEL XR tablets for the treatment of ADHD in adults.
3. ADDitude Magazine - Dyanavel XR Safe and Effective to Treat ADHD in Children.
4. FDA NDA 210526 - Dyanavel XR (Amphetamine Extended-Release Tablets) NDA/BLA Multi-disciplinary Review and Evaluation.
5. Biospace - Tris Pharma, Inc. Announces The Launch Of DYANAVEL XR Amphetamine Extended-Release Oral Suspension CII For The Treatment Of Children With ADHD.