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DYANAVEL XR Drug Patent Profile

Which patents cover Dyanavel Xr, and when can generic versions of Dyanavel Xr launch?

Dyanavel Xr is a drug marketed by Tris Pharma Inc and is included in two NDAs. There are ten patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in DYANAVEL XR 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

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.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DYANAVEL XR

International Patents:	21
US Patents:	7
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	2
Patent Applications:	4,367
Drug Prices:	Drug price information for DYANAVEL XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DYANAVEL XR
What excipients (inactive ingredients) are in DYANAVEL XR?	DYANAVEL XR excipients list
DailyMed Link:	DYANAVEL XR at DailyMed

See drug prices for DYANAVEL XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DYANAVEL XR

Constraining patent/regulatory exclusivity:

9,675,703

NDA:

208147

Dosage:

SUSPENSION, 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

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

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

See all DYANAVEL XR clinical trials

Pharmacology for DYANAVEL XR

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

US Patents and Regulatory Information for DYANAVEL XR

DYANAVEL XR is protected by seven US patents.

This potential generic entry date is based on patent 9,675,703.

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	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes	11,590,228		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
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes	9,675,703		Y
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes	10,086,087		Y
Tris Pharma Inc	DYANAVEL XR 15	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-003	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	11,590,081		Y

International Patents for DYANAVEL XR

When does loss-of-exclusivity occur for DYANAVEL XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Russian Federation

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DYANAVEL XR 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
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Denmark	2018160
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА

DYANAVEL XR 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 introduction. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Need and Demand

The demand for effective ADHD treatments is high and growing, driven by the increasing diagnosis and awareness of ADHD. DYANAVEL XR, with its unique LiquiXR® platform technology, fills a critical need by providing a once-daily dosing option that combines immediate and extended release characteristics. This convenience and efficacy have contributed to its market appeal[4].

Product Forms and Approvals

DYANAVEL XR is available in two forms: an extended-release oral suspension and extended-release tablets. The oral suspension was approved by the FDA in 2015, and the tablet formulation was approved in November 2021. The bioequivalence of the tablet form to the oral suspension has been clinically demonstrated, expanding the treatment options for patients[3][5].

Clinical Efficacy and Safety

Clinical trials have shown that DYANAVEL XR is effective in reducing ADHD symptoms in patients aged 6 and older. The medication starts working as early as 30 minutes after administration and maintains efficacy for up to 13 hours. This rapid onset and sustained action are key factors in its market success[1][3][4].

Adverse Effects and Safety Profile

While DYANAVEL XR has a favorable efficacy profile, it also comes with potential adverse effects common to CNS stimulants, such as weight loss, growth suppression in pediatric patients, and peripheral vasculopathy. However, most adverse events reported in clinical trials were mild to moderate in severity[2][4].

Market Competition

The ADHD medication market is highly competitive, with several established brands and formulations. However, DYANAVEL XR's unique delivery mechanism and the convenience of once-daily dosing help it stand out. The availability of both oral suspension and tablet forms further broadens its appeal to a wider range of patients[3][5].

Financial Performance and Revenue

The financial performance of DYANAVEL XR is influenced by several factors, including prescription rates, insurance coverage, and market competition. Since its approval, DYANAVEL XR has seen steady growth in prescriptions, driven by its clinical efficacy and the expanding ADHD treatment market.

Revenue Growth

The launch of the tablet formulation in 2022 marked a significant milestone, expanding the product's reach and potentially increasing revenue. Clinical trials demonstrating the efficacy and safety of the tablet form have further bolstered its market position[3][4].

Pricing and Reimbursement

The pricing strategy for DYANAVEL XR is critical to its financial trajectory. The medication is generally priced competitively with other ADHD treatments, and its reimbursement by major insurance providers helps in maintaining a strong market presence. However, the cost can be a barrier for some patients, and Tris Pharma may need to navigate pricing strategies carefully to balance profitability with patient access[5].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of DYANAVEL XR. FDA approvals and compliance with manufacturing standards are essential for maintaining market presence. Any compliance issues, such as those mentioned in the FDA review, can impact production and sales[5].

Future Outlook

The future outlook for DYANAVEL XR is promising, given its established efficacy and the growing demand for ADHD treatments. Tris Pharma's commitment to further research and development, as well as the potential for expansion into new patient populations (e.g., children under 6 years old), could further enhance its market position and financial performance[1][4].

Key Takeaways

• Clinical Efficacy: DYANAVEL XR is effective in reducing ADHD symptoms with a rapid onset and sustained action.
• Market Forms: Available in oral suspension and tablet forms, both of which have been clinically proven to be effective.
• Safety Profile: Common adverse effects are consistent with other CNS stimulants, but most are mild to moderate.
• Market Competition: Unique delivery mechanism and once-daily dosing differentiate it in a competitive market.
• Financial Performance: Steady growth in prescriptions and revenue, with potential for further expansion.

FAQs

Q: What is the primary mechanism of action of DYANAVEL XR? A: DYANAVEL XR is a central nervous system (CNS) stimulant that increases attention and decreases impulsiveness and hyperactivity in patients with ADHD.

Q: How quickly does DYANAVEL XR start working? A: DYANAVEL XR starts working as early as 30 minutes after administration and maintains efficacy for up to 13 hours[1][3].

Q: What are the common adverse effects of DYANAVEL XR? A: Common adverse effects include epistaxis, allergic rhinitis, upper abdominal pain, and other gastrointestinal disturbances. Most adverse events are mild to moderate in severity[2][4].

Q: Is DYANAVEL XR available in different forms? A: Yes, DYANAVEL XR is available in both extended-release oral suspension and extended-release tablet forms[3][5].

Q: What is the recommended dosing for DYANAVEL XR? A: The recommended starting dose is 2.5 mg or 5 mg once daily in the morning, with the option to increase the dose in increments of 2.5 mg to 10 mg per day every four to seven days until an optimal response is obtained[5].

Sources

1. ADHD Medication Update: New Clinical Data for Dyanavel XR - Additudemag.com
2. DYANAVEL XR (amphetamine) - accessdata.fda.gov
3. Tris Pharma Launches Dyanavel XR Tablets for ADHD - Managedhealthcareexecutive.com
4. Tris Pharma Announces Publication of Study Results Highlighting the Efficacy and Safety of DYANAVEL XR (amphetamine) Tablets for the Treatment of the Symptoms of ADHD in Adults - Trispharma.com
5. NDA 210526 Dyanavel XR (Amphetamine Extended-Release Tablets) - Fda.gov