CLINICAL TRIALS PROFILE FOR ADDERALL 30

505(b)(2) Clinical Trials for ADDERALL 30

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 30

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 30

Condition Name

Condition Name for ADDERALL 30
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
ADHD	3
Cocaine Dependence	3

Condition MeSH

Condition MeSH for ADDERALL 30
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL 30

Trials by Country

Trials by Country for ADDERALL 30
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL 30
Location	Trials
New York	9
Massachusetts	7
Illinois	2
Maryland	2
Georgia	2

Clinical Trial Progress for ADDERALL 30

Clinical Trial Phase

Clinical Trial Phase for ADDERALL 30
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL 30
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for ADDERALL 30

Sponsor Name

Sponsor Name for ADDERALL 30
Sponsor	Trials
Shire	7
National Institute on Drug Abuse (NIDA)	5
New York State Psychiatric Institute	5

Sponsor Type

Sponsor Type for ADDERALL 30
Sponsor	Trials
Other	45
Industry	13
NIH	8

Last updated: April 23, 2026

Clinical Trials Update, Market Analysis and Projection for Adderall 30

What is “Adderall 30” in commercial and clinical terms?

“Adderall 30” refers to extended-release mixed amphetamine salts tablet products labeled as 30 mg (typical label strength for mixed amphetamine salts ER formulations used for ADHD and related indications). The branded product is marketed as Adderall XR (commonly dispensed in 30 mg strength). Generic equivalents exist and are widely substitutable at the ingredient and strength level for most payers and formularies.

Because this is a marketed, widely dispensed CNS stimulant with a mature evidence base, “clinical trials update” focuses on: (1) new indications or subpopulations, (2) label expansions tied to study readouts, and (3) post-approval manufacturing/clinical compliance work that does not typically move core market drivers.

---

What clinical trial activity matters for Adderall 30 right now?

At this stage of product lifecycle, the practical trial view is:

• No new “blockbuster” trial readouts are typically needed to sustain the current ADHD indication and competitive position because the product is already established and entrenched in guidelines, payer coverage, and prescriber routines.
• Ongoing activity in the category largely concentrates on comparative effectiveness, adherence/tolerability, pharmacokinetic performance, abuse-deterrent or formulation work, and real-world outcomes rather than late-stage phase pivots that materially change the label for established ER mixed amphetamine salts.

Current actionable lens for investors and R&D planners:

1. Competitive evidence: new entrants and reformulations often seek de novo differentiation through dosing convenience, safety/tolerability positioning, and payer-friendly support materials rather than replacing the clinical role of mixed amphetamine salts ER.
2. Safety monitoring: stimulant safety continues to be evaluated through postmarketing surveillance, pregnancy registries, pediatric monitoring, and cardiovascular risk stratification studies.
3. Adherence and switching: switching between branded and generic ER mixed amphetamine salts is common; trials that quantify adherence persistence or time-to-discontinuation can influence payer and health plan contracting.

Bottom line: for “Adderall 30,” the clinically meaningful updates in most markets are driven by label stability plus category dynamics (generic penetration, rebate pressure, and payer step edits), not by new phase-defining clinical endpoints.

---

How is the ADHD stimulant market structured for Adderall 30?

The commercial market for “Adderall 30” sits inside the broader ADHD prescription stimulant class, which is split across:

• Mixed amphetamine salts (including Adderall XR and generics)
• Methylphenidate-based stimulants (a large competing segment)
• Non-stimulants (atomoxetine, guanfacine ER, clonidine ER, viloxazine ER in some geographies)

Commercial reality:

• Patients remain on therapy long-term when tolerated; churn is usually substitution rather than abandonment.
• Payers drive volume toward formulary-preferred options, often favoring generics unless branded offers strong contracting.

---

What market forces determine pricing and volume for Adderall 30?

For a 30 mg ER mixed amphetamine salts product, the main levers are:

1) Generic competition

• Adderall XR has had extensive generic entry pressure. Branded volumes typically depend on rebate and contracting intensity.
• Generic mixed amphetamine salts ER tablets at equivalent strength act as near-substitutes for coverage and dispensing decisions.

2) Formulary design

• Step therapy, prior authorization, quantity limits, and substitution rules influence net revenue more than raw prescription growth.
• Payer behavior often shifts during annual contracting cycles, producing quarter-to-quarter volatility in branded share.

3) Controlled-substance operational friction

• Stimulant distribution remains subject to inventory management, prescriber adoption patterns, and pharmacy fulfillment constraints.
• Shortages or supply fluctuations in stimulant categories can temporarily affect fill rates and switching patterns.

4) Clinical switching behavior

• Switching from ER to IR or between different ER stimulant chemistries changes persistence and side-effect profiles.
• Providers often remain within a chemistry family when effective; this sustains the “mixed amphetamine salts ER” revenue pool even as branded share varies.

---

What is the demand outlook for ADHD stimulant therapy used as Adderall 30?

Demand growth in ADHD stimulant markets typically comes from:

• Pediatric incidence and diagnosis rates
• Ongoing adherence in treated patients
• Adult ADHD identification and prescribing
• Expansion of covered indications and payer acceptance in adult populations (where applicable)

Offsetting factors:

• Patent and exclusivity effects on branded share (generics keep expanding their base)
• Payer tightening and higher utilization management
• Stimulant supply and controlled-substance logistics

---

Market projection: where does Adderall 30 fit in the next 3 to 5 years?

A defensible projection framework for Adderall 30 must model:

• Category growth (ADHD prevalence plus diagnosis plus persistence)
• Share shift (branded to generic within mixed amphetamine salts ER)
• Cross-class substitution (methylphenidate ER and other stimulants; non-stimulants where clinicians or payers push alternatives)
• Contracting cycle effects (rebates and formulary tiering)

Projection (directional, business-useful):

• Total prescriptions for mixed amphetamine salts ER at 30 mg-equivalent strengths should track overall stimulant ADHD volume growth with moderate inflation from coding and diagnosis trends.
• Branded revenue for the 30 mg strength is expected to grow slower than prescription counts due to rebate compression and generic price pressure.
• Generic “Adderall 30” equivalents should capture most volume growth; they will generally outperform branded revenue growth while remaining sensitive to payer contracting and PBM formulary leverage.

Given typical stimulant class dynamics, the most likely scenario over 3 to 5 years is:

• Stable or modestly rising unit demand
• Decreasing branded net price
• Increasing generics share and contestability via formularies

---

Competitive landscape: what threatens or supports Adderall 30?

Support

• Established role in ADHD treatment pathways with high clinician familiarity
• ER dosing aligns with adherence needs
• Broad payer familiarity and coverage history

Threats

• Aggressive payer substitution to generics
• Competitive ER formulations in methylphenidate classes with strong rebate positions
• Non-stimulant alternatives in patients at higher cardiovascular risk or with intolerance to stimulants
• Any sustained supply constraint that increases switching away from a specific manufacturer’s supply chain

---

How should R&D and investment teams think about the “30 mg” specific opportunity?

Even when “30 mg” is a strength label, the business question is usually:

• Can the company maintain a defensible position for the ER mixed amphetamine salts franchise in preferred tiers?
• Can it improve contracting economics (rebates, patient support, adherence programs) to protect net revenue?
• Can it reduce total cost of care through dosing convenience, persistence, or safety risk mitigation narratives?

For most established products, incremental R&D is typically:

• Bioequivalence and formulation process improvements
• Supportive clinical work that sustains clinician confidence
• Real-world outcomes generation for payers (adherence persistence, discontinuation rates, and adverse event rates)

---

Key Takeaways

• “Adderall 30” is best treated as the 30 mg strength within ER mixed amphetamine salts that sits inside the mature ADHD stimulant market.
• Clinical impact in this lifecycle stage is usually label stability plus postmarketing and real-world evidence, not phase-defining novelty.
• Market performance is driven primarily by generic penetration, payer contracting, and formulary design, not by new efficacy breakthroughs.
• Over 3 to 5 years, the base case is stable/modest prescription growth with slower branded net revenue growth and stronger performance by generic equivalents.

---

FAQs

1) Is Adderall 30 expected to face a near-term clinical label change?

No. The product category is mature; market dynamics in this phase are driven more by contracting and substitution than by new label-changing trials.

2) Does generic competition affect prescriptions for Adderall 30?

It can reduce branded share but typically does not reduce total category volume; it shifts volume to generic equivalents at equivalent strength and ER performance.

3) What determines whether a payer prefers Adderall 30 vs alternatives?

Formulary tiering, rebates, step edits/prior authorization criteria, and substitution rules among ER stimulants and non-stimulants.

4) Which comparator classes most directly compete with Adderall 30?

Other ER stimulant chemistries, especially methylphenidate-based ER products, plus non-stimulants in patients where stimulants are poorly tolerated or clinically constrained.

5) What is the most likely market trajectory for branded vs generic versions?

Branded net revenue growth typically lags as generics expand share; generics generally capture the majority of unit growth.

---

References

[1] FDA. Drug Approval Package and prescribing information resources for Adderall XR (mixed amphetamine salts extended-release). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/