~ Buy the DYANAVEL XR 15 (amphetamine; amphetamine aspartate/dextroamphetamine sulfate) Drug Profile, 2024 PDF Report in the Report Store ~

DYANAVEL XR 15 Drug Patent Profile

Which patents cover Dyanavel Xr 15, and what generic alternatives are available?

Dyanavel Xr 15 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 15 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 15

Indicators of Generic Entry

Summary for DYANAVEL XR 15

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	DYANAVEL XR 15 at DailyMed

Recent Clinical Trials for DYANAVEL XR 15

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

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

See all DYANAVEL XR 15 clinical trials

Pharmacology for DYANAVEL XR 15

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

US Patents and Regulatory Information for DYANAVEL XR 15

DYANAVEL XR 15 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 15	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-003	Nov 4, 2021		RX	Yes	No			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 15	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-003	Nov 4, 2021		RX	Yes	No			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

International Patents for DYANAVEL XR 15

See the table below for patents covering DYANAVEL XR 15 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2378573
Taiwan	200812649	Modified release formulations containing drug-ion exchange resin complexes
Japan	2009530298
China	101400343	Modified release formulations containing drug-ion exchange resin complexes
World Intellectual Property Organization (WIPO)	2007109104

Market Dynamics and Financial Trajectory for DYANAVEL XR

Introduction to DYANAVEL XR

DYANAVEL XR, developed by Tris Pharma, is a federally controlled substance (CII) used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. It is available in two primary forms: an extended-release oral suspension and extended-release tablets.

Clinical Efficacy and Market Forms

DYANAVEL XR has demonstrated significant clinical efficacy in reducing ADHD symptoms, characterized by a rapid onset and sustained action. The drug is available in oral suspension and extended-release tablet forms, both of which have been approved by the FDA. The tablets, in particular, were developed as a line extension and alternate dosage form for the oral suspension, leveraging Tris Pharma's LiquiXR platform technology[2][5].

Market Position and Competition

DYANAVEL XR operates in a competitive ADHD treatment market. The drug's unique formulation and delivery mechanism, such as the LiquiXR technology, provide it with a distinct market position. However, the ADHD market is crowded with various treatments, including other amphetamine-based products and non-amphetamine alternatives.

Patent Landscape and Generic Entry

The patent landscape for DYANAVEL XR is complex, with multiple patents and regulatory exclusivities in place. There have been several patent litigation cases, indicating strong interest from generic manufacturers. As of recent data, 63% of patent challenges are decided in favor of the generic patent challenger, and 54% of successful challengers promptly launch generic drugs. The estimated loss of exclusivity (LOE) date for DYANAVEL XR is a critical factor in determining when generic versions might enter the market[1].

Regulatory and Compliance Issues

The FDA approval process for DYANAVEL XR tablets was not without challenges. The manufacturing facility faced compliance issues, including an FDA warning letter in 2018, which delayed the approval. Once these issues were resolved, the product was approved, but additional post-marketing studies were required to expand its use to younger pediatric patients[2].

Clinical Trials and Efficacy Studies

DYANAVEL XR has undergone several clinical trials to establish its efficacy and safety. A Phase 3 study in adults with ADHD showed statistically significant improvements in attention, as measured by the Permanent Product Measure of Performance Total (PERMP-T) scores. Similar studies in children aged 6 to 12 years also demonstrated efficacy, though with some common adverse reactions such as epistaxis, allergic rhinitis, and upper abdominal pain[3][4].

Adverse Reactions and Safety Profile

The safety profile of DYANAVEL XR includes common adverse reactions such as headache, decreased appetite, irritability, and insomnia. Most of these reactions are mild to moderate in severity. Serious adverse events, such as manic symptoms, peripheral vasculopathy, and serotonin syndrome, are also potential risks, especially when used with other medications[3][4].

Market Availability and Supply

Despite the challenges in the ADHD medication market, including shortages of other drugs like Adderall, Tris Pharma has ensured the continued supply and availability of DYANAVEL XR tablets and oral suspension. This stability in supply is crucial for maintaining market share and patient trust[3].

Financial Trajectory

The financial performance of DYANAVEL XR is influenced by several factors, including its market share, pricing, and the potential for generic competition. Given its strong clinical efficacy and unique delivery mechanism, DYANAVEL XR has likely generated significant revenue for Tris Pharma.

• Revenue Generation: The drug's approval and subsequent market acceptance have contributed to its revenue. The extended-release tablets, in particular, offer a convenient alternative to the oral suspension, potentially increasing patient adherence and thus revenue.
• Pricing and Cost: As a federally controlled substance, the pricing of DYANAVEL XR is closely monitored. Any price increases must be justified by new clinical evidence to avoid scrutiny from regulatory bodies and payers.
• Generic Competition: The eventual entry of generic versions will likely impact the financial trajectory of DYANAVEL XR. Generic competition can lead to a significant reduction in market share and revenue, although the exact timing and impact depend on the resolution of patent litigation and regulatory exclusivities[1][5].

Market Forecast

Predicting the exact financial future of DYANAVEL XR involves several variables, including the timing of generic entry, market demand, and competitive dynamics.

• Short-Term Outlook: In the short term, DYANAVEL XR is expected to maintain its market position due to its established efficacy and the lack of immediate generic competition.
• Long-Term Outlook: The long-term outlook is more uncertain. The entry of generic versions could significantly erode market share and revenue. However, Tris Pharma's continued innovation and potential brand extensions could help mitigate these effects.

Key Takeaways

• Clinical Efficacy: DYANAVEL XR has demonstrated strong clinical efficacy in treating ADHD.
• Market Forms: Available in oral suspension and extended-release tablet forms.
• Patent Landscape: Complex patent landscape with potential for generic entry.
• Regulatory Issues: Compliance issues delayed FDA approval but have since been resolved.
• Safety Profile: Common adverse reactions are generally mild to moderate.
• Market Availability: Stable supply despite market challenges.
• Financial Trajectory: Revenue generation is strong, but generic competition poses a future risk.

FAQs

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

Q: What forms is DYANAVEL XR available in? A: DYANAVEL XR is available in extended-release oral suspension and extended-release tablet forms.

Q: What are the common adverse reactions associated with DYANAVEL XR? A: Common adverse reactions include headache, decreased appetite, irritability, and insomnia, among others.

Q: Why is DYANAVEL XR a federally controlled substance? A: DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine, which has potential for abuse.

Q: What is the impact of generic competition on DYANAVEL XR? A: Generic competition could significantly reduce DYANAVEL XR's market share and revenue, although the exact timing depends on patent litigation and regulatory exclusivities.

Sources

1. DrugPatentWatch: DYANAVEL XR Drug Patent Profile.
2. FDA: NDA 210526 Dyanavel XR (Amphetamine Extended-Release Tablets).
3. BioSpace: Tris Pharma Announces Continued Supply and Availability of DYANAVEL XR.
4. FDA: dyanavel® xr - accessdata.fda.gov.
5. Managed Healthcare Executive: Tris Pharma Launches Dyanavel XR Tablets for ADHD.