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DYANAVEL XR 20 Drug Patent Profile

When do Dyanavel Xr 20 patents expire, and when can generic versions of Dyanavel Xr 20 launch?

Dyanavel Xr 20 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 20 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 20

Indicators of Generic Entry

Summary for DYANAVEL XR 20

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	DYANAVEL XR 20 at DailyMed

Recent Clinical Trials for DYANAVEL XR 20

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

Sponsor	Phase
Tris Pharma, Inc.	Phase 4
Tris Pharma, Inc.	Phase 3

See all DYANAVEL XR 20 clinical trials

Pharmacology for DYANAVEL XR 20

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for DYANAVEL XR 20

DYANAVEL XR 20 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 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes	11,590,081		Y
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes	8,747,902		Y
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes	9,675,704		Y
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes	8,337,890		Y

International Patents for DYANAVEL XR 20

See the table below for patents covering DYANAVEL XR 20 around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Brazil	PI0709606	formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica
South Korea	101495146

DYANAVEL XR 20 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 a central nervous system stimulant prescription medicine specifically designed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older. It is the first and only extended-release liquid amphetamine available in the market, offering a unique dosage form that addresses the needs of pediatric patients[1][2].

Market Need and Unmet Medical Needs

The launch of DYANAVEL XR filled a significant gap in the ADHD treatment market by providing an age-appropriate formulation for pediatric patients. Traditional ADHD medications often come in tablet or capsule forms, which can be challenging for young children to swallow. The liquid formulation of DYANAVEL XR allows for customized dosing, making it easier for children to take their medication[1][2].

Regulatory Approval and Launch

DYANAVEL XR received approval from the U.S. Food and Drug Administration (FDA) in October 2015. The drug was launched in U.S. pharmacies in April 2016, marking a significant milestone for Tris Pharma as the only pediatric company to introduce an extended-release liquid amphetamine for ADHD treatment[1][2].

Clinical Efficacy

The efficacy of DYANAVEL XR was evaluated in a laboratory classroom setting involving children with ADHD aged 6 to 12 years. The results showed that DYANAVEL XR improved attention and behavior, and significantly reduced impulsivity and hyperactivity. These improvements were observed starting at one hour and lasted up to 13 hours after dosing, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP)[1][2].

Side Effects and Safety Profile

While DYANAVEL XR has demonstrated efficacy, it also comes with a set of potential side effects. Common side effects reported in clinical studies include epistaxis (nosebleed), allergic rhinitis, and upper abdominal pain. More serious risks include increased blood pressure and heart rate, peripheral vasculopathy, and the potential for substance use disorder due to its high abuse potential[1][2][5].

Market Positioning and Competition

DYANAVEL XR's unique liquid formulation sets it apart from other ADHD medications, which are predominantly in tablet or capsule forms. This differentiation allows Tris Pharma to capture a specific segment of the market focused on pediatric care. However, the ADHD treatment market is highly competitive, with several established brands and generic options available. The success of DYANAVEL XR depends on its ability to maintain market share through its unique formulation and clinical efficacy[1][2].

Financial Trajectory

The financial performance of DYANAVEL XR is influenced by several factors, including prescription rates, insurance coverage, and competition from other ADHD medications. While specific financial data for DYANAVEL XR is not publicly available, the launch of the drug marked a significant investment for Tris Pharma. The company's commitment to bringing age-appropriate formulations to market suggests a long-term strategy aimed at capturing a substantial share of the pediatric ADHD treatment market.

Revenue Growth and Market Dynamics

The ADHD treatment market is characterized by continuous innovation and the introduction of new formulations. The revenue growth of DYANAVEL XR would be influenced by its adoption rate among healthcare providers and patients, as well as any changes in market dynamics such as new product launches or shifts in consumer preferences. Given its unique formulation, DYANAVEL XR has the potential to maintain a stable market position and contribute significantly to Tris Pharma's revenue[1][2].

Challenges and Opportunities

One of the significant challenges for DYANAVEL XR is its high potential for abuse and misuse, which can lead to regulatory scrutiny and public health concerns. However, this also presents an opportunity for Tris Pharma to engage in public health initiatives and educational programs to ensure safe use of the medication.

Expansion and Line Extensions

Tris Pharma has also developed an extended-release tablet formulation of DYANAVEL XR, which was submitted for FDA approval under a 505(b)(2) NDA. This line extension aims to provide an alternative dosage form, further expanding the market reach of DYANAVEL XR. The tablet formulation, if approved, would offer patients another option for managing their ADHD symptoms, potentially increasing the overall market share of the drug[4].

Post-Marketing Requirements and Future Studies

The FDA has recommended additional clinical development programs for DYANAVEL XR, particularly for pediatric patients aged 4-5 years, as part of post-marketing requirement (PMR) studies. These studies will help in further establishing the safety and efficacy of DYANAVEL XR in younger age groups, potentially expanding its market[4].

Key Takeaways

• Unique Formulation: DYANAVEL XR is the first extended-release liquid amphetamine for ADHD treatment, catering specifically to pediatric patients.
• Clinical Efficacy: Demonstrated significant improvements in attention and behavior, and reduction in impulsivity and hyperactivity.
• Safety Profile: Associated with potential side effects and a high risk of abuse and misuse.
• Market Positioning: Differentiated by its liquid formulation, targeting the pediatric ADHD treatment market.
• Financial Trajectory: Influenced by prescription rates, insurance coverage, and competition within the ADHD treatment market.
• Challenges and Opportunities: High abuse potential presents both challenges and opportunities for public health initiatives and educational programs.

FAQs

Q: What is DYANAVEL XR used for? A: DYANAVEL XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older[1][2].

Q: What makes DYANAVEL XR unique? A: DYANAVEL XR is the first and only extended-release liquid amphetamine available for ADHD treatment, allowing for customized dosing for pediatric patients[1][2].

Q: What are the common side effects of DYANAVEL XR? A: Common side effects include epistaxis (nosebleed), allergic rhinitis, and upper abdominal pain. More serious risks include increased blood pressure and heart rate, and peripheral vasculopathy[1][2][5].

Q: Is DYANAVEL XR safe for children under 6 years old? A: It is not known if DYANAVEL XR is safe and effective in children under 6 years of age. Additional studies are recommended for this age group[1][4].

Q: What are the potential risks associated with DYANAVEL XR? A: DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder. It is also associated with increased blood pressure and heart rate, and peripheral vasculopathy[1][2][5].

Cited Sources

1. Tris Pharma Announces the Launch of DYANAVEL™ XR (amphetamine) Extended-release Oral Suspension, CII for the Treatment of Children with ADHD - Tris Pharma.
2. Tris Pharma, Inc. Announces The Launch Of DYANAVEL XR (amphetamine) Extended-release Oral Suspension, CII for the Treatment of Children with ADHD - BioSpace.
3. Drug Expenditure Dynamics 1995-2020 - IQVIA.
4. NDA 210526 Dyanavel XR (Amphetamine Extended-Release Tablets) - FDA.
5. Dyanavel XR: Package Insert / Prescribing Information - Drugs.com.