CLINICAL TRIALS PROFILE FOR ADDERALL 15

505(b)(2) Clinical Trials for ADDERALL 15

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 15

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.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	Otsuka Pharmaceutical Co., Ltd.	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 15

Condition Name

Condition Name for ADDERALL 15
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
Cocaine Dependence	3
Attention Deficit Hyperactivity Disorder (ADHD)	3

Condition MeSH

Condition MeSH for ADDERALL 15
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL 15

Trials by Country

Trials by Country for ADDERALL 15
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL 15
Location	Trials
New York	9
Massachusetts	7
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for ADDERALL 15

Clinical Trial Phase

Clinical Trial Phase for ADDERALL 15
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL 15
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for ADDERALL 15

Sponsor Name

Sponsor Name for ADDERALL 15
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for ADDERALL 15
Sponsor	Trials
Other	45
Industry	13
NIH	8

Clinical Trials Update, Market Analysis, and Projection for ADDERALL 15

Last updated: October 29, 2025

Introduction

Adderall 15mg, a central nervous system stimulant predominantly prescribed for Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy, remains a critical component within psychostimulant therapy. As the patent landscape evolves and generics flood the market, understanding clinical trial updates, market dynamics, and future projections becomes essential for stakeholders. This comprehensive analysis synthesizes recent clinical developments and market forecasts, offering insights for investors, healthcare providers, and pharmaceutical companies.

Clinical Trials Update

Status and Recent Developments

Traditional formulations of Adderall, including the 15mg dose, are off patent, with several generic versions approved by regulatory agencies globally. However, recent clinical trials focus not on reformulations of Adderall itself but on novel therapeutic agents targeting similar neurocognitive pathways or attempting to improve safety and efficacy profiles.

Ongoing Trials and Innovations

• Prodrug and Extended-Release Formulations: Research is underway to develop extended-release versions that optimize once-daily dosing, improve compliance, and reduce abuse potential. For instance, ADVANC (Adhansia XR’s successor) investigates novel delivery mechanisms but does not specifically target the 15mg dose.

• Alternative Therapies and Adjuncts: Several clinical trials have evaluated non-stimulant drugs—like Lisdexamfetamine, Guanfacine, and Atomoxetine—as alternatives or adjuncts in ADHD management, which impacts Adderall prescribing patterns indirectly.

• Abuse-Deterrent Formulations (ADFs): Modified formulations engineered to resist crushing or dissolution are being tested. No specific clinical trials are currently focusing solely on 15mg doses in this category, but regulatory-approved ADFs, such as Adderall XR with abuse-deterrent properties, have demonstrated effectiveness in reducing misuse.

Regulatory and Safety Highlights

Recent clinical trials have reinforced the safety profile of Adderall at 15mg doses, particularly with regards to cardiovascular risks and potential for misuse. The FDA continues to monitor the safety through post-marketing surveillance, but no significant concerns or new contraindications have surfaced recently.

Emerging Data and Future Trials

The pipeline for ADHD pharmacotherapy is robust. Notably:

• Neuroimaging and biomarker trials aim to better understand the neurobiological effects of stimulants like Adderall.
• Genetic studies seek to personalize treatment, potentially influencing future dosing protocols.

While these sophisticated developments could impact the role of traditional doses like 15mg, no major ongoing trials aim for a reformulation or repurposing specifically targeting this dosage.

Market Analysis

Current Market Landscape

Adderall, introduced in 1996, is among the top prescribed medications for ADHD worldwide. The 15mg dose aligns with the pocket-sized, versatile dosing regimen favored by practitioners, balancing efficacy and tolerability.

Market Size and Growth

• The global ADHD medication market was valued at approximately $13 billion in 2022[1], with a compound annual growth rate (CAGR) forecasted around 4.5% from 2023 to 2030.
• The U.S. dominates the market, accounting for over 70% of prescriptions, driven by high diagnosis rates and prescribing conventions.

Market Share of Adderall and Generics

• Brand Adderall XR (produced by the original manufacturer, Shire/Affirm) holds a significant but declining share due to patent expiry in 2019.
• Generic versions of Adderall IR, including 15mg, have gained considerable market share, with multiple manufacturers such as Teva, Sun Pharma, and Mylan competing aggressively on price and formulation variations.

Pricing and Reimbursement

• The average wholesale price (AWP) for a 30-count, 15mg Adderall pill ranges between $7 to $10 per pill depending on the manufacturer.
• Generics have decreased the cost of therapy by approximately 30-50% since patent expiration.
• Insurance reimbursements generally favor generics, improving accessibility and consumption.

Market Trends and Drivers

• Increasing ADHD diagnosis: Rising awareness, especially among adults, propels demand.
• Legislative Changes: Stricter monitoring of Schedule II stimulants (including Adderall), intended to curb abuse, may influence prescribing behavior but has not significantly suppressed market growth.
• COVID-19 Impact: The pandemic initially reduced prescription rates due to healthcare disruptions but subsequently led to a surge in telehealth-based ADHD treatment.

Competitive Landscape

Major players include:

• Janssen Pharmaceuticals (Adderall XR)
• Teva Pharmaceuticals
• Mylan (now part of Viatris)
• Sun Pharmaceutical Industries

These firms actively compete on formulary placement, pricing, and formulations, including extended-release variants.

Market Projections and Future Outlook

Forecast for 2023–2030

• Market Expansion: The global ADHD treatment market, driven predominantly by North America, is projected to reach $18-20 billion by 2030.
• Adderall's Market Share: Despite generic penetration, Adderall remains a leading stimulant, anchoring over 40% of the ADHD stimulant share in the U.S..
• Emerging Alternatives: Non-stimulant drugs and behavioral therapies are expanding, potentially challenging stimulant dominance, but stimulants like Adderall will remain core due to their proven efficacy.

Factors Influencing Future Growth

• Regulatory Environment: Continued scheduling and abuse-deterrent regulations could influence formulation preferences.
• Innovation: Novel formulations with improved safety profiles or novel delivery systems may cannibalize traditional IR doses.
• Personalized Medicine: Pharmacogenetics may lead to tailored dosing strategies, potentially reducing reliance on broad dosing categories like 15mg.

Risks and Challenges

• Regulatory Restrictions: Potential tightening of prescribing habits or increased surveillance on Schedule II substances.
• Market Saturation: High adoption rates could plateau without innovation.
• Public and Professional Perception: Increasing concerns about stimulant misuse could impact prescribing norms.

Key Takeaways

• Stable Clinical Profile: The 15mg dose of Adderall remains a cornerstone of ADHD management, with a well-characterized safety profile reinforced by ongoing clinical data.
• Market Dominance: Despite patent expiries and generic competition, Adderall retains significant market share, driven by widespread acceptance and the clinical need for stimulant therapy.
• Growth Prospects: The global market is expected to grow at a CAGR of approximately 4.5% through 2030, with emphasis on generic proliferation and new formulations.
• Innovation Edge: Abuse-deterrent formulations and extended-release options are likely to influence prescribing patterns, potentially impacting 15mg IR formulations but also increasing overall market access.
• Regulatory and Societal Factors: Evolving regulations and societal perceptions surrounding stimulant misuse could temper growth but also motivate innovation and safer formulations.

FAQs

1. Will the patent for Adderall brand eventually expire, and how will that affect the 15mg dose?
Yes. The original patent expired in 2019, enabling the entry of generic formulations. This has increased accessibility and reduced prices but has also intensified competition, pressuring brand pricing and market share.

2. Are there ongoing clinical trials specifically testing the efficacy of 15mg Adderall?
No. Clinical studies focus primarily on broader formulations, safety profiles, or new drugs. The 15mg dose, as a standard, remains the clinical reference point but isn't the subject of specific trials.

3. How might regulatory changes impact the sales of Adderall 15mg?
Regulations targeting abuse, such as tighter scheduling or mandatory Prescription Drug Monitoring Programs (PDMPs), could restrict prescribing and influence the use of 15mg doses, especially in vulnerable populations.

4. What role do non-stimulant therapies play in relation to Adderall 15mg?
Non-stimulants like Atomoxetine and Guanfacine serve as alternatives for patients intolerant to stimulants or at risk for misuse; however, stimulants like Adderall continue to dominate due to superior efficacy.

5. How significant is the threat of generic competition to the future sales of Adderall 15mg?
It remains substantial. High-quality generics have dramatically reduced prices, which can compress margins for branded versions but also sustains market volume through increased accessibility.

---

Sources

1. Grand View Research. ADHD Treatment Market Size, Share & Trends Analysis Report. 2022.