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.

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
Attention Deficit Hyperactivity Disorder (ADHD)	3
Major Depressive Disorder	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
Minnesota	2
Illinois	2
Maryland	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
Not yet recruiting	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

Adderall 30 Clinical Trials Update, Market Analysis and 2026+ Projection for FDA-Approved IR Mixed Amphetamine Salts

Last updated: July 28, 2026

What clinical trials update exists for Adderall 30 (amphetamine salts) and what data matters for investors?

Answer: No public, drug-specific “Adderall 30” clinical trial stream is identifiable from the information provided. “Adderall 30” is a label strength of immediate-release mixed amphetamine salts (typically supplied as 30 mg total daily dose strength in some markets), not a distinct active pharmaceutical ingredient or separate regulatory product category.

Which trials typically drive the modern stimulant landscape for Adderall-like products?

For investor-level updates, the trials that usually move the needle fall into these buckets:

• Bioequivalence and formulation equivalence studies for generic or authorized-EDR (immediate-release) products using the same active ingredient(s).
• Switch and adherence studies in ADHD populations assessing onset, dosing consistency, and day-to-day symptom control.
• Safety expansions, including cardiovascular screening outcomes and exposure characterizations in special populations (pediatrics, adolescents, adult ADHD, comorbidities).
• Abuse-deterrence and misuse-resistance programs (more common in extended-release and prodrug/novel delivery platforms than in immediate-release).

What “update” should be treated as decision-grade for Adderall 30?

Decision-grade updates for an IR amphetamine combination generally come from:

• FDA labeling changes (new warnings, dosing limits, or ADHD subpopulation language).
• Post-approval safety signals (lifetime exposure surveillance, stimulant class risk reassessment).
• Market access changes driven by payer policy or controlled-substance scheduling updates (these drive utilization faster than small clinical datasets).

Is Adderall 30 the same as other Adderall strengths, and does that change exclusivity or clinical evidence requirements?

Answer: Adderall 30 is a dosage strength within the same branded product line, and it does not typically create a separate exclusivity or evidence track distinct from other Adderall strengths.

What changes across strengths in practice?

• Formulation and dosage strength can affect excipient composition but usually does not change mechanism of action.
• Clinical evidence is usually tied to the active ingredient and dosage form class (immediate-release mixed amphetamine salts), with strength-specific adjustments focused on dose titration schedules.

Why investors still track strength-level dynamics

• Shortages and supply constraints often affect specific strengths disproportionately, shifting substitution into other IR strengths or into other stimulant classes.
• Payer formularies and step edits can be strength- and package-size sensitive.

What patents protect Adderall 30 and how strong is the patent estate for immediate-release mixed amphetamine salts?

Answer: A strength-labeled product like Adderall 30 generally relies on the same upstream composition and use IP that historically covered branded Adderall immediate-release products; current “strength” typically has no standalone patent moat. For patent-lifecycle and litigation risk, the correct unit of analysis is the branded product family and its dosage form category, not the milligram strength.

How to interpret patent estate strength for an IR branded stimulant

For market projection and competitive threat modeling, the key questions are:

• Whether any method-of-use or formulation patents still grant enforceable exclusivity in core jurisdictions.
• Whether authorized generics or court settlements have already cleared most barriers.
• Whether any additional protection applies only to specific packaging or manufacturing steps.

What generic entry risks exist for Adderall 30, including Paragraph IV and authorized generic dynamics?

Answer: For Adderall IR strengths, the principal generic entry risk is typically already realized; the remaining risk is supply, exclusivity carve-outs, and litigation holdbacks rather than fresh patent cliffs.

What usually determines entry timing after most patents are cleared

• Ability to source compliant controlled-substance procurement and manufacturing quotas.
• FDA ANDA approvals with bioequivalence and labeling adequacy.
• Litigation stays or settlement-driven “carve-out” periods that preserve branded market share.

What is the FDA and Orange Book status of Adderall (immediate-release mixed amphetamine salts) and what does it imply for Adderall 30?

Answer: Orange Book status is strength and product-form dependent, but Adderall 30 is not typically an independent regulatory dossier. The operative question is whether any listed Orange Book patents still attach to the immediate-release NDA product covering IR mixed amphetamine salts.

Decision-grade interpretation

• If no listed patents remain for the IR NDA, generic substitution can be commercially immediate where supply allows.
• If one or more patents remain for method-of-use or formulation, the relevant risk is launch timing at the granularity of patent-to-ANDA certification.

How does Adderall 30 compete versus Vyvanse, Ritalin, Concerta, and other ADHD stimulants in commercial terms?

Answer: Adderall (IR) competes primarily on dosing flexibility, prescriber familiarity, and payer coverage, with substitution driven by availability and formulary design rather than sustained differentiated clinical evidence for the IR strength itself.

Competitive substitutability drivers

• Formulary placement of stimulants and step edits
• Shortage spillover between IR amphetamine, ER amphetamine, IR methylphenidate, and ER methylphenidate
• Patient-specific tolerability and clinical response patterns

What to model for market share movement

• Month-by-month availability gaps by strength
• Net price dynamics driven by contracted volume and pharmacy benefit incentives
• Switch rates among IR strengths or from IR to ER within the same molecule class

What is the ADHD stimulant market size exposure relevant to Adderall 30, and what 2026+ scenario ranges should be used?

Answer: Without verified market-size baselines, projections cannot be stated accurately. The correct approach is to tie Adderall 30 forecasts to (1) branded Adderall IR total category performance, (2) stimulant class share shifts, and (3) controlled-substance supply constraints.

Projection model structure that works for IR stimulant strengths

For an IR strength forecast, robust projection inputs are:

• Branded unit demand trend for immediate-release amphetamine salts
• Net revenue per prescription under payer contracts (rebates and discounts)
• Substitution headwinds (generic penetration, IR-to-ER migration, class switching)
• Supply constraint elasticity (how quickly patients and prescribers switch)

Scenario logic investors typically apply

• Base case: stable branded utilization with normal substitution into generics and ER where IR supply tightens
• Upside: improved supply and payer-friendly contraction improves branded retention
• Downside: persistent shortages or increased substitution into ER or alternative molecules reduces IR branded share

What do recent market signals imply for Adderall 30 pricing, volume, and payer policy?

Answer: No validated, drug-specific pricing/volume signals are provided in the information received, so a quantified readout cannot be produced.

Signals that usually move Adderall IR markets

• Pharmacy purchasing and wholesale inventory reporting trends (availability of specific strengths)
• Payer medical policy and formulary updates
• Prescriber switching patterns post-shortage normalization

What litigation or settlement activity affects Adderall 30 market exclusivity and generic launch?

Answer: Litigation outcomes cannot be asserted without specific docket and settlement details. For investor workflows, you would map:

• Case caption, court, and asserted patents
• Certification type (Paragraph IV, etc.)
• Settlement terms (launch date carve-outs, exclusivity waivers)
• Remaining barriers by strength, label, and dosage form

How should investors treat Adderall 30 risk from biosimilars or non-oral stimulants?

Answer: Biosimilar risk is not a relevant driver for Adderall 30. Adderall 30 is a small-molecule CNS stimulant, not a biologic.

Relevant “pipeline” risk for Adderall IR

The substitution risk is more likely from:

• Novel extended-release oral stimulant formulations
• Non-stimulant ADHD products that erode marginal demand
• Longer-acting stimulant options that reduce daily dosing burden

Key Takeaways

• “Adderall 30” is best treated as a strength within immediate-release mixed amphetamine salts, not as a distinct IP or clinical trial program.
• Decision-grade updates for branded IR stimulant strengths are dominated by FDA labeling, controlled-substance supply conditions, payer policy, and any remaining Orange Book-linked enforceable patents attached to the IR NDA product line.
• Market projections for Adderall 30 require validated branded utilization baselines, net pricing assumptions, and substitution/supply elasticity. Those inputs are not present here, so quantified projections cannot be provided without risking error.

FAQs

1. What is the difference between Adderall immediate-release and extended-release for market and patent risk?
2. Does “Adderall 30” have separate FDA exclusivity from other Adderall strengths?
3. How do pharmacy shortages by strength affect branded versus generic substitution for stimulant IR products?
4. Which Orange Book patent types most commonly delay generic entry for IR stimulant brands?
5. What payer policies most influence patient switching between amphetamine and methylphenidate stimulant classes?

References (APA)

No sources were provided in the prompt.