ADDERALL 15 Drug Patent Profile

Which patents cover Adderall 15, and what generic alternatives are available?

Adderall 15 is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in ADDERALL 15 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

Summary for ADDERALL 15

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	11
DailyMed Link:	ADDERALL 15 at DailyMed

Recent Clinical Trials for ADDERALL 15

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Gagan Joshi	PHASE4
Massachusetts Institute of Technology (MIT)	PHASE4
Boston Children's Hospital	Phase 1

See all ADDERALL 15 clinical trials

US Patents and Regulatory Information for ADDERALL 15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Womens	ADDERALL 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-013	Aug 31, 2000		DISCN	Yes	No

Expired US Patents for ADDERALL 15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ADDERALL 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-013	Aug 31, 2000	6,384,020*PED

International Patents for ADDERALL 15

See the table below for patents covering ADDERALL 15 around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1202739
Japan	2003504406
World Intellectual Property Organization (WIPO)	0105407
Mexico	PA02000290	FORMA DE DOSIFICACION ORAL DE LIBERACION INMEDIATA RAPIDA. (RAPID IMMEDIATE RELEASE ORAL DOSAGE FORM.)
Canada	2378336
Australia	6089200

Market Dynamics and Financial Trajectory for ADDERALL 15

Last updated: July 27, 2025

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Introduction

ADDERALL 15, a formulation of the prescription stimulant composed primarily of amphetamine salts, continues to occupy a significant niche within the pharmaceutical landscape. Its unique positioning as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy has driven consistent demand, supported by evolving regulatory environments and market trends. This analysis dissects the key drivers influencing ADDERALL 15’s market dynamics and projects its financial trajectory amid the contemporary healthcare and pharmaceutical sectors.

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Market Landscape of ADDERALL 15

Therapeutic Market Overview

ADDERALL 15 is part of the broader stimulant medication category used predominantly for ADHD management. The global ADHD therapeutics market was valued at approximately USD 11 billion in 2021 and is projected to grow at a CAGR of roughly 7% through 2028 [1]. This expansion is driven by increased awareness, diagnosis, and the continuous development of advanced formulations.

ADDERALL’s brand recognition and established efficacy have ensured steady sales within its niche. While newer agents such as LDX (Lisdexamfetamine) and non-stimulant options like atomoxetine have emerged, ADDERALL remains a first-line treatment choice, especially among pediatric and adult ADHD patients.

Regulatory Environment

From regulatory perspectives, ADDERALL falls under strict control due to its potential for misuse and abuse. The DEA classifies it as Schedule II under the Controlled Substances Act, imposing constraints on prescribing and dispensing practices. Regulatory expectations influence marketing strategies and reimbursement pathways, constraining rapid market expansion but ensuring stability for existing formulations.

Competitive Dynamics

The competitive landscape features both branded and generic products. The patent expiry or expiration of ADDERALL’s patents—particularly the original formulations—has led to a proliferation of generic competitors, intensifying price competition while confirming its market prominence. The introduction of D-amphetamine and mixed salts generics has increasingly impacted brand sales.

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Factors Influencing Market Dynamics

1. Increasing ADHD Diagnosis

Rising ADHD diagnosis rates, attributed to greater awareness and refined diagnostic standards, underpin ongoing demand. In the US, nearly 9.8% of children aged 3–17 received an ADHD diagnosis in 2016, with adult prevalence also rising [2]. This demographic trend directly correlates with increased prescriptions for stimulant formulations, including ADDERALL 15.

2. Prescriber Preferences and Prescribing Trends

Physicians favor ADDERALL due to its long-standing efficacy profile. However, guidelines favor minimizing abuse potential, which may influence prescription patterns toward non-stimulant or extended-release alternatives. The advent of refinements in formulation—such as extended-release versions—aims to reduce abuse while maintaining therapeutic efficacy.

3. Pricing, Reimbursement, and Market Penetration

Price elasticity plays a vital role. Generics have precipitated a decline in per-unit costs for ADDERALL, encouraging broader access and adherence. Reimbursement policies, particularly in the US, are favorable for established drugs with proven efficacy, sustaining sales.

4. Abuse and Diversion Dynamics

Given its Schedule II status, misuse and diversion remain significant challenges. Ongoing efforts to develop abuse-deterrent formulations and prescriber education are integral to market stability. These dynamics influence formulary inclusion and prescribing behaviors.

5. Emerging Treatments and Market Competition

The pipeline of newer agents, including non-stimulant medications and non-pharmacological interventions, could impact ADDERALL’s market share. Nonetheless, the combination of effective symptom control and familiarity sustains its relevance.

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Financial Trajectory of ADDERALL 15

Revenue Outlook

ADDERALL’s revenues, historically buoyed by sustained demand, are projected to face margin pressures from generic competition. Nevertheless, the overall market growth for ADHD treatments and the drug’s entrenched position support a resilient revenue stream.

In 2022, the global ADDERALL segment, including the 15 mg formulation, was estimated to generate sales upwards of USD 2.5 billion, predominantly in North America. Considering exclusive brand positioning, pricing strategies, and market penetration, revenues may stabilize or decline slightly over the next five years, barring significant regulatory, clinical, or market disruptions.

Impact of Patent and Exclusivity

The expiration of certain patents and exclusivity periods has increased generic competition, leading to price erosion. Data indicates that generic formulations typically sell at 40–60% of the brand-name price upon market entry [3], compressing profit margins for branded manufacturers but expanding overall market volume.

Strategic Initiatives and Growth Levers

Manufacturers can leverage several strategies to enhance profitability:

• Innovation in Formulation: Developing abuse-deterrent or extended-release variants to maintain market share.
• Market Expansion: Targeting emerging markets with increasing ADHD diagnoses.
• Value-Added Services: Incorporating adherence programs or companion diagnostics to differentiate.

Risks and Challenges

Potential risks tempering financial growth include:

• Regulatory Scrutiny: Stringent controls on prescribing and scheduling.
• Market Saturation: Saturation in mature markets diminishes incremental growth.
• Competition from Non-Stimulant Drugs: Rise in non-stimulant options may dilute demand.

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Long-term Outlook

The outlook for ADDERALL 15’s financial trajectory hinges on a complex interplay of healthcare trends, regulatory evolution, and market competition. While immediate prospects suggest constrained growth due to generics and market saturation, strategic diversification, formulation innovation, and emerging global markets could foster alternative avenues for revenue growth.

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Key Takeaways

• Steady Demand with Evolving Competition: ADDERALL 15 benefits from high therapeutic efficacy and established prescriber trust, though generic competition exerts downward pressure on margins.
• Regulatory Oversight Is Pivotal: Tight control over prescribing and potential abuse mitigation strategies influence market stability.
• Market Expansion Critical in Emerging Economies: As ADHD awareness expands globally, there remain opportunities for growth outside mature markets.
• Innovation Drives Future Financial Sustainability: Development of abuse-deterrent and long-acting formulations can sustain profitability.
• Pricing Strategies and Reimbursement Policies Are Critical: Navigating these will determine long-term revenue streams amid intense price competition.

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FAQs

1. How does patent expiration affect ADDERALL 15’s market share?
Patent expiration introduces generic competitors, typically leading to significant price reductions and increased market penetration, which often results in declining brand sales but expanding overall market volume.

2. What are the primary regulatory challenges for ADDERALL 15?
Strict scheduling as a Schedule II controlled substance enforces prescribing restrictions and counters misuse. Future regulatory changes toward abuse-deterrent formulations or prescribing guidelines could impact market access.

3. How does the rise of non-stimulant ADHD medications influence ADDERALL’s financial prospects?
Non-stimulant drugs like atomoxetine serve as alternatives, especially for patients at risk of abuse or with contraindications, potentially decreasing demand for stimulant formulations but also diversifying treatment options.

4. What innovations could enhance ADDERALL 15’s marketability?
Development of abuse-deterrent formulations, extended-release options, and digital adherence tools could bolster prescribing confidence and patient adherence.

5. Is international expansion a viable growth avenue for ADDERALL 15?
Yes, especially in emerging markets with rising ADHD diagnoses, but regulatory, cultural, and infrastructural factors must be navigated carefully.

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References

[1] Grand View Research. ADHD Therapeutics Market Size, Share & Trends Analysis Report, 2021.
[2] Centers for Disease Control and Prevention. Data & Statistics on ADHD, 2016.
[3] IQVIA. Market Data Reports, 2022.