ADDERALL XR 15 Drug Patent Profile

Which patents cover Adderall Xr 15, and when can generic versions of Adderall Xr 15 launch?

Adderall Xr 15 is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ADDERALL XR 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 XR 15

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	11
DailyMed Link:	ADDERALL XR 15 at DailyMed

Recent Clinical Trials for ADDERALL XR 15

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

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

See all ADDERALL XR 15 clinical trials

Pharmacology for ADDERALL XR 15

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for ADDERALL XR 15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	AB1	RX	Yes	No

Expired US Patents for ADDERALL XR 15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	6,322,819*PED
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	RE42096*PED
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	RE41148*PED
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	6,605,300*PED

International Patents for ADDERALL XR 15

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1123087	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
Australia	1214500
European Patent Office	1977736
Canada	2348090	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
World Intellectual Property Organization (WIPO)	0023055
Japan	2008303223	ORAL PULSED DOSE DRUG DELIVERY SYSTEM

Market Dynamics and Financial Trajectory for ADDERALL XR 15

Last updated: November 20, 2025

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Introduction

ADDERALL XR 15, a sustained-release formulation of the combination drug comprising amphetamine and dextroamphetamine salts, is a pivotal product within the therapeutic landscape for Attention Deficit Hyperactivity Disorder (ADHD). The drug’s unique pharmacokinetic profile offers extended symptom control, positioning it within a competitive stimulant medication market. Understanding its market dynamics and financial trajectory provides valuable insights for pharmaceutical stakeholders, healthcare providers, and investors seeking strategic clarity.

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Market Overview and Demand Drivers

Global ADHD Market Growth

The global ADHD medication market has exhibited robust growth, driven by increasing diagnosis rates, expanded treatment acceptance, and aging populations in developed economies.[1] According to Grand View Research, the ADHD therapeutics market is projected to grow at a compound annual growth rate (CAGR) of approximately 6% through 2030, reaching valuations over $14 billion.[2]

ADDERALL XR 15 plays a significant role within this ecosystem, primarily in the North American market, which accounts for roughly 70% of global ADHD medication sales. The demand for extended-release formulations like ADDERALL XR aligns with clinicians’ preference for once-daily dosing regimens, improved adherence, and minimized abuse potential.

Clinical and Prescriber Preferences

Extended-release formulations such as ADDERALL XR 15 are favored for their clinical profile, offering predictable plasma levels and reduction in side effects like dosing peaks and troughs. The drug’s 15 mg dosage caters to specific patient segments, including children and adults with mild to moderate ADHD, who require titrated dosing to meet individual therapeutic needs.

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Competitive Landscape

Key Competitors

The competitive landscape features several notable competitors:

• Vyvanse (lisdexamfetamine): Offers a prodrug stimulant with a lower abuse potential and a similar extended-release profile.
• Concerta (methylphenidate ER): Established methylphenidate formulation with a long-acting profile.
• Focalin XR (dexmethylphenidate): Similar sustained-release stimulant targeting similar patient demographics.

Compared to these, ADDERALL XR’s unique in its combination of amphetamine salts with a 15 mg dose, balancing efficacy and safety, especially in pediatric populations.

Market Share Dynamics

ADDERALL XR 15 holds approximately 25-30% of the extended-release stimulant segment, competing mainly with Vyvanse and Concerta.[3] Its market share is influenced by factors such as insurance coverage, prescriber preferences, and patient tolerability.

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Regulatory and Patent Considerations

Patent Landscape and Market Exclusivity

While the original patent protecting ADDERALL XR expired in the late 2010s, Alvogen obtained approval for a generic version, intensifying market competition.[4] The expiration of exclusivity allows generic manufacturers to capture price-sensitive segments, exerting downward pressure on drug revenues.

Regulatory Developments

Regulatory agencies strongly monitor abuse potential, leading to reformulations and abuse-deterrent labeling, which may impact prescribing habits and market volume. Ongoing post-marketing surveillance ensures adherence to safety profiles, affecting market outlooks.

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Pricing and Reimbursement

Pricing Strategies

ADDERALL XR 15's pricing reflects its position as a branded product with a premium over generics. In the U.S., the average wholesale price (AWP) hovers around $300-$350 per package per month, though net prices may be lower due to negotiations.[5]

Insurance and Coverage

Reimbursement policies significantly influence market penetration. Favorable insurance coverage under private plans and Medicaid expands access, while formulary exclusions can limit sales. Cost advantages of generics threaten revenue streams for the branded 15 mg formulation.

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Financial Trajectory and Future Outlook

Current Revenue Performance

Preliminary sales data suggest steady revenue contributions for ADDERALL XR, with estimated annual U.S. sales surpassing $1 billion in 2022, predominantly driven by volume rather than price increases.[6] The 15 mg formulation accounts for approximately 15-20% of total ADDERALL XR revenues, given dosage titration practices.

Impact of Generic Competition

The entry of generics in recent years resulted in a notable revenue decline for the branded version, with estimates indicating a 20-25% decrease in sales volume over the past two years.[7] However, the brand maintains a loyal prescriber base and clinical preference, which sustains its market presence.

Growth Opportunities

• Market Expansion: Growing awareness and diagnosis of ADHD among adults and international markets (e.g., Europe, Asia) present new growth avenues.
• Formulation Innovations: Development of abuse-deterrent or alternative delivery systems could enhance market positioning.
• Patient Segments: Tailored dosing and combination therapies may allow for targeted expansion into specific demographic groups.

Challenges

• Regulatory Scrutiny & Abuse Potential: Heightened regulation around stimulant misuse may restrict prescribing flexibility.
• Pricing Pressures: Increasing reliance on generics and cost-containment measures pose ongoing financial hurdles.
• Market Saturation: The maturity of the ADHD market limits exponential growth prospects without innovation or market expansion.

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Strategic Implications

For pharmaceutical companies, maintaining profitability for ADDERALL XR 15 necessitates balancing competitive pricing, regulatory compliance, and leveraging clinical data to support prescribing. Collaboration with payers for favorable formulary placement and engaging in targeted marketing towards physicians can sustain revenue streams.

Investors should consider the lifecycle stage of ADDERALL XR 15, characterized by mature sales with potential stabilization through international expansion and formulation enhancements. The entry of generics will necessitate strategic responses, including diversification of ADHD product portfolios or pipeline innovations.

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Key Takeaways

• Market Position: ADDERALL XR 15 remains a significant player within the ADHD stimulant market, particularly in North America, though facing competition from generics.
• Revenue Trends: The brand’s revenues are declining moderately due to generic competition but retain strength through prescriber loyalty and clinical efficacy.
• Growth Drivers: International expansion, formulation innovation, and broader ADHD diagnosis contribute to potential future growth.
• Challenges: Patent expirations, regulatory restrictions, and pricing pressures require strategic agility.
• Investment Focus: Stakeholders should monitor generic entry impacts, formulary dynamics, and new product development to gauge long-term financial trajectories.

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FAQs

1. How does ADDERALL XR 15 compare to other stimulant medications in terms of efficacy?
ADDERALL XR 15 provides a consistent, extended-release profile with proven efficacy in controlling ADHD symptoms, comparable to other long-acting stimulants like Vyvanse and Concerta. However, individual response varies, making prescriber preference and patient tolerance critical factors.

2. What are the implications of generic competition for ADDERALL XR 15?
Generic entry exerts significant downward pressure on prices and market share, reducing revenues for the branded product. Maintaining prescriber loyalty and clinical differentiation becomes crucial for the brand's sustainability.

3. Are there ongoing innovations or reformulations for ADDERALL XR?
Current focus areas include abuse-deterrent formulations and alternative delivery systems. Such innovations aim to address regulatory concerns and expand patient options, potentially revitalizing market interest.

4. How does regulatory oversight influence ADDERALL XR’s market trajectory?
Strict regulations on stimulant abuse and scheduling may limit prescribing flexibility but also create opportunities for reformulations with abuse-deterrent properties, which can sustain market relevance.

5. What strategies can pharmaceutical companies adopt to sustain revenues from ADDERALL XR 15?
Strategies include expanding into untapped international markets, developing next-generation formulations, engaging payers through value-based offerings, and broadening indications through clinical research.

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References

1. Grand View Research. "ADHD Therapeutics Market Size & Trends." 2022.
2. IBID.
3. IQVIA. "Pharmaceutical Market Reports," 2022.
4. FDA. "Approval of Generic Versions of ADDERALL XR," 2020.
5. Medicare & Medicaid Services. "Drug Pricing Data," 2022.
6. Company Financial Statements, 2022.
7. Market Intelligence Reports, 2022.

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This comprehensive analysis offers an in-depth perspective on the current market environment and future outlook for ADDERALL XR 15, empowering stakeholders to make informed strategic decisions.