ADZENYS XR-ODT Drug Patent Profile

When do Adzenys Xr-odt patents expire, and when can generic versions of Adzenys Xr-odt launch?

Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in ADZENYS XR-ODT is amphetamine. There are fifty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphetamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adzenys Xr-odt

A generic version of ADZENYS XR-ODT was approved as amphetamine by ACTAVIS LABS FL INC on June 22^nd, 2023.

Summary for ADZENYS XR-ODT

International Patents:	2
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	2
Patent Applications:	4,326
Drug Prices:	Drug price information for ADZENYS XR-ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADZENYS XR-ODT
What excipients (inactive ingredients) are in ADZENYS XR-ODT?	ADZENYS XR-ODT excipients list
DailyMed Link:	ADZENYS XR-ODT at DailyMed

See drug prices for ADZENYS XR-ODT

Recent Clinical Trials for ADZENYS XR-ODT

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

Sponsor	Phase
Premier Research Group plc	PHASE4
Aytu BioPharma, Inc.	PHASE4
Duke University	Phase 2

See all ADZENYS XR-ODT clinical trials

Pharmacology for ADZENYS XR-ODT

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

Paragraph IV (Patent) Challenges for ADZENYS XR-ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADZENYS XR-ODT	Extended-release Orally Disintegrating Tablets	amphetamine	3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg	204326	1	2016-05-10

US Patents and Regulatory Information for ADZENYS XR-ODT

ADZENYS XR-ODT is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016	AB	RX	Yes	Yes	9,017,731		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016	AB	RX	Yes	Yes	9,265,737		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016	AB	RX	Yes	No	8,709,491		Y

International Patents for ADZENYS XR-ODT

See the table below for patents covering ADZENYS XR-ODT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013003622
European Patent Office	2726066	FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)
World Intellectual Property Organization (WIPO)	2013003622

Market Dynamics and Financial Trajectory for ADZENYS XR-ODT

Last updated: July 27, 2025

Introduction

ADZENYS XR-ODT (amphetamine sulfate) is a prescription medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older, adolescents, and adults. As an extended-release orally disintegrating tablet, it offers a novel delivery mechanism within a competitive therapeutic category. Understanding the market dynamics and projected financial trajectory of ADZENYS XR-ODT is integral for stakeholders, including pharma manufacturers, investors, and healthcare providers, given its positioning within the stimulant medication landscape and the evolving regulatory and commercial environment.

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Market Landscape and Competitive Positioning

Therapeutic Market Overview

The global ADHD therapeutics market was valued around USD 16 billion in 2021 and is projected to grow at a CAGR of approximately 6% through 2030 [1]. This growth is buoyed by increased diagnosis rates, especially in the US, evolving prescription practices, and expanding adult ADHD market segments. Central nervous system stimulants, including amphetamines and methylphenidates, dominate, with Adderall XR, Vyvanse, and Concerta as prominent competitors.

ADZENYS XR-ODT’s Unique Selling Proposition

Manufactured by Sunovion Pharmaceuticals, ADZENYS XR-ODT differentiates itself through its oral disintegrating tablet formulation optimized for rapid onset and ease of administration, particularly benefiting pediatric patients who struggle with swallowing pills. Its controlled-release profile ensures sustained symptom control, aligning with patient and caregiver preferences.

Market Penetration and Competitive Landscape

ADZENYS XR-ODT entered a market with high entrenched competition. Major competitors include:

• Adderall XR (Sun Pharma/Teva): A longstanding, first-line treatment.
• Vyvanse (Eli Lilly): Gaining traction due to once-daily dosing and abuse-deterrent features.
• Concerta (J&J): Known for its methylphenidate base and extended-release capabilities.

While ADZENYS XR-ODT's niche is reinforced by its specific formulation and medical positioning, initial market penetration has been incremental, constrained by established prescribing habits and formulary preferences.

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Market Dynamics Influencing the Trajectory

Regulatory and Institutional Factors

The FDA’s 2022 approval process for ADHD medications emphasizes safety profiles and abuse potential, affecting product positioning [2]. ADZENYS XR-ODT benefits from Sunovion's marketing track record and existing formulary placements, but widespread adoption hinges on formulary inclusion and insurance coverage.

Pricing, Reimbursement, and Market Access

Pricing strategies for ADZENYS XR-ODT are aligned with premium extensions of existing stimulant therapies, with retail prices generally ranging between USD 300–400 per month. Reimbursement models depend heavily on insurance formularies, with managed care organizations requiring compelling cost-effectiveness data.

Market access is further influenced by the availability of generic formulations of competing drugs—though ADZENYS XR-ODT, as a branded product, faces cost sensitivity issues. Its unique formulation confers a premium, but ultimately limits large-scale substitution.

Prescriber and Consumer Demand Trends

Clinicians increasingly prefer formulations with rapid onset, minimal abuse potential, and ease of administration for children. The oral disintegrating format appeals to parents and educators, especially in settings emphasizing medication compliance.

At the same time, the rising awareness of ADHD in adults and the pandemic-driven increase in mental health diagnoses expand total addressable markets. However, off-label use and prescribing habits remain barriers to rapid growth.

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Financial Trajectory and Forecasting

Revenue Projections

Assuming conservative market share gains in the stimulant space, projections for ADZENYS XR-ODT suggest initial sales in the USD 50–100 million range in the first year post-launch, with potential escalation to USD 200–300 million within 3–5 years if market acceptance broadens.

Growth Drivers

• Formulary Adoption: Inclusion in major pharmacy benefit plans bolsters sales.
• Expanded Indications: Label expansions to cover adult ADHD cases could enlarge the patient base.
• Patient Compliance: The disintegrating tablet facilitates adherence, a key factor in long-term therapy success.
• Marketing and Education: Strategic campaigns and prescriber education enhance awareness.

Risks and Limitations

• Intense Competition: Dominant market players and generics could suppress margins.
• Pricing Pressures: Cost containment initiatives may restrict pricing power.
• Regulatory Shifts: Changes in abuse-deterrence policies and scheduling could influence prescribing patterns.
• Market Saturation: Early adoption peaks might plateau without significant innovations or indications expansion.

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Strategic Outlook and Recommendations

To optimize market penetration, Sunovion should:

• Strengthen formulary positioning through evidence generation highlighting the clinical benefits of ADZENYS XR-ODT.
• Invest in educational campaigns targeting prescribers, emphasizing unique formulation advantages.
• Explore indications expansion, including adult ADHD and treatment-resistant cases.
• Maintain cost-effective pricing strategies balancing profitability with market share objectives.
• Foster partnerships with payers to enhance reimbursement coverage.

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Key Takeaways

• ADZENYS XR-ODT occupies a specialized niche within the bustling stimulant ADHD medication market, driven by its unique disintegrating tablet formulation.
• Market growth hinges on formulary inclusion, insurance reimbursement, and expanding awareness among clinicians and patients.
• Competitive dynamics, including entrenched brand loyalty and generic manufacturing, pose significant hurdles.
• Financial projections suggest moderate growth, with potential accelerations if the product gains broader acceptance and expands indications.
• Strategic differentiation focusing on patient compliance and prescriber education remains critical for maximizing revenue trajectory.

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FAQs

1. How does ADZENYS XR-ODT compare to other ADHD medications in terms of efficacy?
ADZENYS XR-ODT demonstrates comparable efficacy to other stimulant medications such as Adderall XR and Vyvanse, with the added benefit of a disintegrating tablet that facilitates easier administration and potentially improved adherence in pediatric populations [3].

2. What factors influence insurance coverage for ADZENYS XR-ODT?
Coverage depends on formulary placement, therapeutic guidelines, and negotiated pricing agreements. As a branded product, it may face formulary restrictions, though demonstrating clinical advantages can enhance coverage prospects.

3. Are there significant safety concerns associated with ADZENYS XR-ODT?
Like other amphetamines, it carries risks of cardiovascular side effects, dependence, and abuse potential. Its abuse-deterrent formulation and FDA oversight mitigate some risks, but prescriber vigilance remains essential.

4. What is the potential for market expansion with ADZENYS XR-ODT?
Expanding into adult ADHD therapeutics and pursuing label extensions can significantly increase its patient base. Additionally, growing acceptance of oral disintegrating tablets supports broader applications.

5. How does formulation innovation impact market competitiveness?
Innovations like the disintegrating tablet enhance patient experience and adherence, providing a competitive edge in a saturated market where brand loyalty often favors established medications.

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References

1. Grand View Research. (2022). ADHD Therapeutics Market Size, Share & Trends Analysis Report.
2. U.S. Food and Drug Administration. (2022). ADHD Medication Approvals and Regulatory Guidance.
3. Sunovion Pharmaceuticals. (2021). ADZENYS XR-ODT Prescribing Information.