CLINICAL TRIALS PROFILE FOR ADDERALL XR 10

505(b)(2) Clinical Trials for ADDERALL XR 10

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 10

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 XR 10

Condition Name

Condition Name for ADDERALL XR 10
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
Attention Deficit Hyperactivity Disorder (ADHD)	3
Major Depressive Disorder	3

Condition MeSH

Condition MeSH for ADDERALL XR 10
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL XR 10

Trials by Country

Trials by Country for ADDERALL XR 10
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL XR 10
Location	Trials
New York	9
Massachusetts	7
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for ADDERALL XR 10

Clinical Trial Phase

Clinical Trial Phase for ADDERALL XR 10
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL XR 10
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for ADDERALL XR 10

Sponsor Name

Sponsor Name for ADDERALL XR 10
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for ADDERALL XR 10
Sponsor	Trials
Other	45
Industry	13
NIH	8

ADDERALL XR 10 Market Analysis and Financial Projection

Last updated: April 30, 2026

Adderall XR 10 (amphetamine mixed salts extended-release): clinical trials update, market analysis, and projection

Summary: Adderall XR 10 mg (mixed amphetamine salts extended-release) is an established, branded CNS stimulant with a stable US footprint driven by chronic use and payer coverage rather than new clinical pipelines at the product-label level. Publicly traceable “new” clinical activity at the level of Adderall XR itself is limited in recent years; the clinical update is dominated by formulation/label maintenance activity, comparative bioequivalence work, and post-marketing safety monitoring typical for mature IR/ER stimulant products. Market dynamics are shaped by (1) US generic penetration, (2) constrained-availability episodes tied to controlled-substance supply chains, (3) prescriber substitution between IR and ER, and (4) payer step-therapy and formulary management for ADHD. For a 10 mg strength specifically, demand tracks total Adderall XR and broader amphetamine XR share, with the 10 mg SKU acting as a dosing “mid-band” that supports titration and maintenance schedules rather than being the primary volume driver.

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What clinical trials are currently active or newly reported for Adderall XR 10 (amphetamine mixed salts ER 10 mg)?

Public trial signals for Adderall XR (product-level)

• Active/published trials specifically branded as “Adderall XR” in the US are sparse in the most recent public record.
• Recent public clinical activity for the stimulant class is more concentrated in:
  • Bioequivalence and formulation work for generic ER amphetamine mixes and authorized generics.
  • Comparative PK studies (IR vs ER) and switching studies between ER products.
  • Safety surveillance, adherence, and real-world outcomes rather than novel efficacy endpoints.

How this translates at the 10 mg SKU level

• Clinical trial enrollment is generally not strength-specific at the branded label level; studies that include Adderall XR typically treat strength as a dosing variable within the approved range.
• Any “Adderall XR 10” evidence that would matter for market access is typically already established in:
  • The approved ER mechanism and duration (extended-release dosing behavior).
  • Label indications for ADHD (and related label constraints, depending on the regulatory record for the product).

Practical takeaway for an investor/R&D screen

For Adderall XR, “pipeline optionality” is not determined by a steady stream of new, high-enrollment product trials. It is determined by:

• Generic/gx competitive pressure (pricing and interchangeability).
• Supply continuity and controlled-substance manufacturing throughput.
• Label maintenance and any incremental label language tied to safety communications or risk evaluation work.

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What is the market context for Adderall XR 10 mg?

Demand drivers

Adderall XR demand is driven by four repeatable forces:

1. ADHD prevalence and persistent treatment use
   • ER stimulants are used for symptom coverage across school/work hours, which supports conversion from IR regimens.
2. Payer coverage and formulary management
   • ER products often face step therapy, prior authorization, and substitution rules.
3. Controlled-substance supply chain
   • Shortages and allocation periods can increase fill rates variability and create “catch-up demand” when supply normalizes.
4. Prescriber switching and patient tolerability
   • ER tends to be preferred when adherence and end-of-day symptom return are issues.

Competitive set

• Direct substitutes: generic amphetamine mixed salts ER products and authorized generics where available.
• Class substitutes: other stimulant ER formulations (methylphenidate ER families and lisdexamfetamine ER) and select non-stimulants for line extensions or those who do not tolerate amphetamines.

Why strength matters for forecasts

• The 10 mg strength is a dosing intermediary commonly used in titration from lower starting doses and in ongoing maintenance depending on patient response.
• Its share of total product demand is typically less than the top-selling “modal” strength (often mid-range strengths), but it acts as a steady volume contributor when prescribers titrate across multiple strengths during the course of therapy.

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How does pricing and generic penetration shape earnings for Adderall XR 10?

US pricing model

For mature branded CNS stimulants:

• Branded prices compress over time as generic entry increases.
• Net revenue becomes more sensitive to:
  • Pharmacy benefit design (copays/coinsurance and preferred tiers).
  • Utilization management decisions (preferred generic vs brand continuation).
  • Contract pricing and wholesaler channel adjustments.

What typically happens to a brand strength SKU

• As generics capture share, the remaining branded volume is increasingly driven by:
  • Brand adherence due to perceived tolerability or “consistent duration.”
  • Patient-specific dosing stability leading to continued ER brand use even when generics exist.

10 mg-specific effect

• The SKU benefits from dosing continuity needs: when a patient stabilizes at 10 mg, switching away can be less likely than switching between higher/lower doses during early titration.
• In payer channels that permit brand continuation for “no tolerability to generic” or “medical necessity,” the middle strengths can hold up better than the extremes (very low and very high doses).

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Market analysis and 12- to 36-month projection for Adderall XR 10

Scope note: Projections below are structured for business planning (volume and share dynamics), not for point-forecast claims on revenues without a validated internal market baseline.

Base case: steady utilization, gradual brand share drift

Assumptions

• ADHD treated population grows with incidence plus continued adult adoption.
• ER utilization maintains share relative to IR.
• Brand share continues to drift modestly due to generic replacement and formulary pressure.
• Controlled-substance supply remains adequate without sustained disruption.

Projection mechanics (how to model 10 mg)

• Model total Adderall XR demand (all strengths) then allocate to 10 mg using a stability band for dosing mix:
  • 10 mg tends to remain a stable fraction of treated volume unless payer or prescriber behavior shifts sharply toward a different ER strength.
• Convert total demand to SKU using a mix factor, then apply net price erosion from contract and payer effects.

Downside case: supply volatility or stronger payer substitution

Assumptions

• Another period of constrained supply reduces monthly fill capacity.
• Payers intensify substitution and reduce brand authorization, pushing patients to generic ER.
• Competitor ER products gain share due to tier changes or patient preference cycles.

Projection mechanics

• Volume dips show up first through fill rate and backorders, then through sustained share loss after substitution becomes “locked in.”
• 10 mg mix can shift down if prescribers streamline regimens to a different modal strength used by plan-preferred products.

Upside case: brand continuation and stabilized tolerability routing

Assumptions

• Supply stabilizes quickly after any temporary constraints.
• Plans maintain brand authorization rates for medical necessity.
• ER preference among stable patients supports continuity at mid-range dosing.

Projection mechanics

• Total Adderall XR holds steady longer, and the 10 mg allocation remains stable because it supports maintenance dosing for a subset of chronic users.

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Commercial implications for R&D, BD, and investment decisions

1) Incremental clinical trials are not the key valuation driver

For Adderall XR, product value is anchored in:

• Channel execution (contracting, formularies, patient access).
• Supply reliability for controlled substances.
• Continued label stability and risk management operations.

2) The “10 mg SKU” is primarily a demand mix lever

Strength-level strategy is about:

• Capturing titration and maintenance flows.
• Avoiding loss of brand continuity when payer substitution happens.
• Managing supply so fills do not push prescribers to lock patients on a substitute ER regimen.

3) Competitor watchlist

Key risks to 10 mg share typically come from:

• Generic ER amphetamine mixed salts absorption.
• Any formulary shifts that prefer a specific ER stimulant across a patient’s entire dosing ladder.
• IR to ER switching or ER to another ER switch driven by coverage and copay design.

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Key Takeaways

• Adderall XR 10 is a mature, branded ER stimulant where recent public clinical trial activity is limited at the product-label level; most new clinical evidence is indirect (PK, bioequivalence, post-marketing and comparative work).
• Market outlook is controlled by payer substitution and controlled-substance supply reliability, not by new efficacy breakthroughs.
• The 10 mg strength is a stable dosing intermediary that tracks overall Adderall XR ER demand, with its share affected by dosing ladder behavior under formulary management.
• 12- to 36-month projections should model total brand demand first, then apply a stable-to-slowly drifting dosing mix factor for 10 mg under base, downside, and upside payer/supply scenarios.

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FAQs

1) Is there meaningful new efficacy trial evidence for Adderall XR specifically at 10 mg?

Publicly traceable new, strength-specific efficacy trials for Adderall XR 10 are limited; most recent activity in this therapeutic area is either class-level or formulation/bioequivalence oriented.

2) Does Adderall XR 10 grow faster than other strengths?

Not usually. The 10 mg SKU typically follows overall ER amphetamine mixed salts dynamics, with changes driven by titration patterns and formulary-driven dosing ladder shifts rather than independent growth.

3) What most affects Adderall XR 10 performance in the US market?

Payer coverage rules, generic substitution pressure, and supply continuity for a controlled-substance manufacturing chain.

4) What is the biggest competitive threat to Adderall XR 10?

Generic amphetamine mixed salts ER uptake and formulary decisions that prefer a different ER stimulant or lock patients to a plan-preferred product once substituted.

5) How should a projection model allocate demand to the 10 mg strength?

Allocate from total Adderall XR demand using a dosing-mix factor for 10 mg and then apply net price erosion and brand-share drift under payer substitution and supply scenario assumptions.

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References

[1] U.S. Food and Drug Administration. Labeling and prescribing information resources for Adderall XR (amphetamine mixed salts extended-release). FDA Drug Labels.
[2] ClinicalTrials.gov. Search results for “Adderall XR” and related terms (condition: ADHD; study type: interventional, observational, PK/bioequivalence). ClinicalTrials.gov database.
[3] IQVIA Institute / IQVIA. US retail prescription trends and ADHD stimulant category dynamics (public summaries and annual outlooks). IQVIA Institute reports and briefs.
[4] FDA. Drug shortages and safety communications related to ADHD stimulant supply and controlled-substance manufacturing (FDA Drug Shortages database, relevant postings). FDA.