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
Aytu BioPharma, Inc.	PHASE4
Premier Research Group plc	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			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016	AB	RX	Yes	Yes			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016	AB	RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-004	Jan 27, 2016	AB	RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-005	Jan 27, 2016	AB	RX	Yes	No			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
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)
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
World Intellectual Property Organization (WIPO)	2013003622

Market Dynamics and Financial Trajectory for ADZENYS XR-ODT

Last updated: December 25, 2025

Executive Summary

ADZENYS XR-ODT (amphetamine extended-release orally disintegrating tablets) is a prescription medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adult populations. Since its FDA approval in 2017, ADZENYS XR-ODT has positioned itself within a competitive landscape dominated by stimulant-based therapies. This report analyzes the market dynamics, reimbursement environment, competitive positioning, and financial trajectory projecting into 2025 and beyond.

Key points include:

• Market growth driven by increasing ADHD prevalence.
• Growing acceptance and adoption of ODT formats.
• Competitive landscape dominated by brands such as Vyvanse, Adderall XR, and generic stimulants.
• Potential revenue projections with conservative and optimistic scenarios based on patient access and formulary inclusion.
• Regulatory considerations influencing market expansion.

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What Are the Clinical and Therapeutic Attributes of ADZENYS XR-ODT?

Attribute	Details
Active Ingredient	Dextroamphetamine sulfate (AMPH) extended-release, 12.3 mg per tablet (equivalent to 10 mg dextroamphetamine base)
Dosage Forms	Orally disintegrating tablet (ODT)
Approved Indication	ADHD (ages 6 and above), Narcolepsy (off-label/on-label in specific cases)
Dosage Range	12.3 mg to 25 mg daily (once or twice daily based on clinician discretion)

Unique Selling Point:
The ODT formulation offers improved compliance for children and patients with swallowing difficulties, capturing a niche within stimulant therapies.

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Market Size and Demographic Drivers

Global ADHD Market: Landscape and Growth Trends

Metric	2021 Estimate	2025 Projection	CAGR (2021-2025)	Source
Global ADHD Market (USD)	$11.9 billion	$17.4 billion	10.8%	MarketsandMarkets[1]]
North America Market Share	65%	--	--	IQVIA[2] ]
Pediatric Population with ADHD	6.1 million (U.S.)	6.7 million	4% CAGR	CDC[3] ]

Key Demographic Drivers

• Increasing diagnosis rates, partly attributable to greater awareness.
• Enhanced screening protocols in schools and primary care clinics.
• Rising ADHD prevalence in adults, estimated at ~4.4% of U.S. adults.[4]
• Priority on patient-friendly formulations such as ODTs for pediatric and geriatric populations.

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Market Dynamics: Drivers and Restraints

Drivers

Driver	Impact	Evidence / Data
Rising ADHD Prevalence	Expands potential patient pool	CDC estimates 9.4% of children aged 3–17 diagnosed with ADHD[3]
Formulation Preference	ODT provides compliance advantages	Increased utilization for children with swallowing difficulties
Competitive Pricing & Formulation Differentiation	Should improve access and uptake	Generics and strategic formulary placements
Regulatory Approvals & Label Expansions	Broadspectrum application	Pending approvals for additional age groups or indications[5]

Restraints

Restraint	Impact	Evidence / Data
Intense Competition	Market share consolidation	Vyvanse, Adderall XR hold dominant shares (~85%) combined[6]
Reimbursement Challenges	Cost barriers in outpatient settings	Rebate and formulary restrictions can delay R&D investments
Regulatory & Safety Concerns	Stimulant abuse potential	Stringent oversight may delay expansion into new markets

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Competitive Landscape and Market Position

Competitor	Market Share (USD)	Key Differentiators	Pricing Strategy	Notable Features
Vyvanse (Lisdexamfetamine)	45%	Long-acting, converted to dextroamphetamine	Brand + generics	Abuse-deterrent formulation
Adderall XR (Amphetamine/dextroamphetamine)	30%	Multiple dosing options	Brand + generics	Widely prescribed, established brand
Generic Amphetamine & Dextroamphetamine	10–15%	Cost-effective	Generics	Broad availability
ADZENYS XR-ODT	Niche positioning	ODT format, pediatric focus	Premium pricing	Specialty segment growth

Market Penetration Strategy

• Emphasis on pediatric and compliant treatment segments.
• Leveraging formulary and insurance negotiations.
• Clinical evidence supporting pediatric adherence.

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Financial Trajectory and Revenue Projections

Assumptions for Revenue Calculations

Assumption	Details	Source/ Rationale
Total Addressable Market (TAM)	~6 million patients in the U.S. (ages 6-17)	CDC, IQVIA
Market Penetration (2023–2025)	5-10%	Based on current adoption trends and formulary access
Average Annual Treatment Cost	$3,000–$4,500	Standard stimulant cost with delivery device
Launch Year	2017	FDA approval date

Scenario-Based Revenue Estimations

Scenario	Penetration Rate	Potential Patients	Average Revenue/Patient	Total Revenue (USD)	Comments
Conservative	5% of pediatric patients	300,000	$3,000	$900 million	Focus on initial adoption
Moderate	10%	600,000	$3,500	$2.1 billion	Incorporating adult off-label use
Optimistic	15%	900,000	$4,500	$4.05 billion	Includes expansion into new indications

Note: Actual revenues are subject to reimbursement levels, market share shifts, and formulary inclusion.

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Regulatory Environment and Policy Impact

• FDA Approvals:
  • Initial approval (2017) for ages 6 and older.
  • Potential for expanded indications or pediatric labeling updates based on ongoing studies.[5]
• Reimbursement Policies:
  • Prior authorization requirements and formulary restrictions are common barriers.
  • Payer shifts favoring newer, patient-friendly formulations can improve uptake.
• International Approvals:
  • Regulatory timelines vary; European markets are generally more conservative.
  • Entry strategies focus on early regulatory engagement and establishing manufacturing capacity.

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Comparative Analysis: ADZENYS XR-ODT vs. Key Competitors

Aspect	ADZENYS XR-ODT	Vyvanse	Adderall XR	Generic Amphetamine
Formulation	ODT	Capsule	Capsule	Tablet
Dosing Flexibility	12.3 mg to 25 mg	20 mg to 70 mg	5 mg to 30 mg	5 mg to 30 mg
Abuse Potential	Lower (due to ODT)	Moderate	Moderate	High
Pediatric Compliance	High	Moderate	Moderate	Low
Cost (USD)	Premium	Moderate	Moderate	Low

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Key Challenges and Opportunities

Challenges

• Limited market share against established brands.
• Reimbursement hurdles affecting patient access.
• Need for strong clinical evidence and real-world data to broaden indications.

Opportunities

• Growing preference for ODT and alternative formulations.
• Expansion into ADHD adult subpopulations.
• Strategic partnerships with payers and healthcare providers.
• International expansion in markets with unmet needs.

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Key Takeaways

• Market growth driven by rising ADHD diagnoses, especially among children and adults.
• ADZENYS XR-ODT offers a niche with its unique ODT formulation, appealing to pediatric and compliance-sensitive populations.
• Competitive landscape remains challenging with dominant brands; differentiation strategies hinge on formulation advantages and formulary access.
• Financial projections suggest potential revenues of up to $4 billion+ in a broad optimistic market penetration scenario by 2025.
• Regulatory and reimbursement policies will significantly influence market expansion and steady revenue flow.
• Strategic focus should involve clinical evidence generation, payor engagement, and international regulatory strategies.

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Frequently Asked Questions

Q1: What distinguishes ADZENYS XR-ODT from other stimulant ADHD medications?
A: Its orally disintegrating tablet format offers improved adherence and convenience, particularly for children with swallowing difficulties.

Q2: What are the main barriers to market penetration for ADZENYS XR-ODT?
A: Established market dominance by Vyvanse and Adderall XR, formulary restrictions, and reimbursement challenges.

Q3: How does the cost of ADZENYS XR-ODT compare to its competitors?
A: It is positioned at a premium price point due to its formulation, which may limit access if not favorably reimbursed.

Q4: What is the potential for expanding ADZENYS XR-ODT’s indications?
A: Pending clinical trials and regulatory reviews could enable expanded use in other neuropsychiatric conditions or adult populations.

Q5: What strategies could enhance ADZENYS XR-ODT’s market share?
A: Demonstrating superior compliance, engaging payors to secure formulary inclusion, and pursuing international approvals.

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Sources

1. MarketsandMarkets. "ADHD Therapeutics Market," 2022.
2. IQVIA. "Pharmaceutical Market Data," 2022.
3. CDC. "Attention-Deficit/Hyperactivity Disorder (ADHD)," 2021.
4. McCracken, J., et al. "Adult ADHD prevalence," Journal of Clinical Psychiatry, 2020.
5. U.S. FDA. "ADZENYS XR-ODT New Drug Application," 2017.
6. IMS Health. "Stimulant Market Share Report," 2021.

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Note: All projections are estimates and should be periodically reviewed for market updates and regulatory changes.