CLINICAL TRIALS PROFILE FOR ADDERALL XR 25

505(b)(2) Clinical Trials for ADDERALL XR 25

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00746733 ↗	Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Completed	Shire	Phase 1	2008-09-08	The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

All Clinical Trials for ADDERALL XR 25

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	National Cancer Institute (NCI)	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	University of South Florida	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00247572 ↗	Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories	Completed	New River Pharmaceuticals	Phase 2	2005-09-01	This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
NCT00248092 ↗	Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse	Completed	New River Pharmaceuticals	Phase 1/Phase 2	2006-01-01	This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to learn if NRP104 produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	Bristol-Myers Squibb	Phase 2	2006-07-01	The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	National Institute of Mental Health (NIMH)	Phase 2	2006-07-01	The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.

Clinical Trial Conditions for ADDERALL XR 25

Condition Name

Condition Name for ADDERALL XR 25
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
ADHD	3
Cocaine Dependence	3

Condition MeSH

Condition MeSH for ADDERALL XR 25
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL XR 25

Trials by Country

Trials by Country for ADDERALL XR 25
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL XR 25
Location	Trials
New York	9
Massachusetts	7
Maryland	2
Georgia	2
Florida	2

Clinical Trial Progress for ADDERALL XR 25

Clinical Trial Phase

Clinical Trial Phase for ADDERALL XR 25
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL XR 25
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for ADDERALL XR 25

Sponsor Name

Sponsor Name for ADDERALL XR 25
Sponsor	Trials
Shire	7
National Institute on Drug Abuse (NIDA)	5
New York State Psychiatric Institute	5

Sponsor Type

Sponsor Type for ADDERALL XR 25
Sponsor	Trials
Other	45
Industry	13
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Adderall XR 25 mg

Last updated: October 30, 2025

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Introduction

Adderall XR 25 mg, a central nervous system stimulant, remains a cornerstone in the management of Attention Deficit Hyperactivity Disorder (ADHD). This extended-release formulation combines amfetamine salts, including mixed amphetamine salts (MAS), offering sustained symptom control. As patent protections expire and generic versions proliferate, understanding the drug's clinical development landscape, market dynamics, and future projections is critical for stakeholders. This article provides a comprehensive update on clinical trials, market analysis, and forecasts for Adderall XR 25 mg.

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Clinical Trials Update

Recent Clinical Trial Landscape

While the primary formulations of Adderall XR have long established their efficacy and safety profiles, ongoing clinical trials focus on comparative effectiveness, safety in diverse populations, and novel uses.

• Comparative Effectiveness Studies: Recent trials compare Adderall XR 25 mg with alternative therapies such as atomoxetine or guanfacine. These studies aim to delineate treatment advantages in specific subpopulations, including pediatric and adult patients.

• Safety Profile and Long-term Effects: Several ongoing observational studies examine the long-term safety of extended-use Adderall XR, particularly concerning cardiovascular risks and potential for abuse.

• Emerging Indications: Exploratory trials investigate the efficacy of Adderall XR in cognitive enhancement in conditions like traumatic brain injury and narcolepsy, although these are not yet approved indications.

Regulatory and Patent Status

The U.S. Food and Drug Administration (FDA) approved Adderall XR in 2001. Patent protections for the original formulation have expired, with numerous generic versions currently marketed. However, the brand retains exclusivity through pediatric labeling and certain formulation patents, which influence market dynamics.

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Market Analysis

Current Market Size and Composition

The global ADHD medication market was valued at approximately $14.2 billion in 2022. Adderall XR, as a leading Prescription Drug in the US, accounts for a substantial segment, estimated at nearly $2.8 billion in sales (IQVIA data). The market comprises:

• Brand-Name Sales: Maintaining substantial market share due to brand recognition and clinician preference.

• Generics: Entered post patent expiry, leading to increased affordability and accessibility, especially in price-sensitive markets.

• Off-Label Uses: Off-label prescriptions for narcolepsy, binge-eating disorder, and cognitive enhancement contribute to sales volume.

Market Trends

• Shift Toward Generics: Generics capture more than 70% of prescriptions, pressuring brand sales but also expanding overall market size through increased accessibility.

• Regulatory Landscape: The FDA's ongoing crackdowns on misuse liability, including rescheduling of stimulants, alter prescribing patterns.

• Digital and Telemedicine Influence: Growth in telehealth consultations increases prescription rates and therapy adherence, especially post-pandemic.

• Patient Demographics: Rising diagnosis rates among adults are expanding the market, with an estimated 10-15% annual growth in adult prescriptions.

Competitive Landscape

Key competitors include:

• Strattera (atomoxetine): Non-stimulant alternative.

• Generic Amphetamine-based formulations: Price competition and similar efficacy.

• Newly Approved Medications: Recent entrants like Vyvanse and Concerta challenge Adderall’s market share.

Market Challenges

• Regulatory and legislative threats: Increased scrutiny on stimulant abuse potential may induce tighter prescribing controls.

• Public perception and abuse concern: Heightened awareness could influence prescriber behavior.

• Patent litigation and biosimilar development could impact exclusivity timelines.

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Market Projection and Future Trends

Forecast Overview

The ADHD drug market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4-6% over the next five years, driven by increased diagnosis, off-label use, and adult patient populations.

Specific Outlook for Adderall XR 25 mg

• Sales Trends: Brand sales are expected to decline marginally due to generic competition but will be offset by increased total volume as accessibility improves.

• Innovation Impact: Development of abuse-deterrent formulations or combination therapies could reshape the market landscape.

• Regulatory Environment: Potential reclassification of stimulants or restrictions could suppress growth momentum temporarily.

• Emerging Markets: Expansion into emerging economies will likely boost sales, though regulatory hurdles may delay adoption.

Strategic Opportunities

• Differentiation through Formulation Improvements: Developing longer-acting or abuse-resistant variants can sustain competitive advantage.

• Expanding Indications: Demonstrating efficacy in novel therapeutic areas can open additional revenue streams.

• Digital Health Integration: Incorporating digital adherence tools and telemedicine partnerships can increase market penetration.

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Key Takeaways

• Clinical support for Adderall XR 25 mg remains robust, with ongoing trials focusing on comparative safety and new indications, although direct reformulation innovations are limited.

• Generic competition has significantly eroded brand sales since patent expiry, though the overall market continues to expand.

• Market growth prospects are strong, driven by rising ADHD diagnoses—particularly in adults—and increased access through digital health innovations.

• Regulatory risks, including potential stricter controls on stimulant prescriptions, may impact long-term growth.

• Emerging markets and therapeutic innovation represent critical avenues for maintaining and expanding market share.

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FAQs

1. What are the main factors influencing Adderall XR 25 mg market dynamics?
   The expiration of patent rights, increased generic availability, rising ADHD diagnosis rates, and regulatory scrutiny are primary influencers.

2. Are there ongoing clinical trials aiming to improve Adderall XR formulations?
   While recent clinical trials primarily compare existing formulations or explore alternative therapies, research into abuse-deterrent formulations is underway but not specific to Adderall XR 25 mg.

3. How does the increasing use of generics affect brand-name sales?
   Generics significantly reduce brand-name sales due to lower prices, but overall medication use increases, expanding total market volume.

4. What future trends could impact the market for Adderall XR 25 mg?
   Innovations in formulation, regulatory changes, demographic shifts toward adult ADHD diagnosis, and digital health integration are major upcoming trends.

5. What are potential new indications for Adderall XR beyond ADHD?
   Preliminary studies are exploring uses in narcolepsy and cognitive deficits in brain injury, but these are experimental and not yet approved.

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References

[1] IQVIA. "2022 ADHD Market Report."
[2] U.S. Food and Drug Administration. "Adderall XR Approval and Regulatory Status."
[3] MarketWatch. "Global ADHD Drugs Market Outlook."
[4] ClinicalTrials.gov. "Ongoing Trials Involving Adderall XR."
[5] FDA. "Stimulant Rescheduling and Abuse-Mitigating Strategies."