ADDERALL 20 Drug Patent Profile

When do Adderall 20 patents expire, and what generic alternatives are available?

Adderall 20 is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in ADDERALL 20 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 20

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	11
DailyMed Link:	ADDERALL 20 at DailyMed

Recent Clinical Trials for ADDERALL 20

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 20 clinical trials

US Patents and Regulatory Information for ADDERALL 20

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 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-008	Feb 13, 1996		DISCN	Yes	No

Expired US Patents for ADDERALL 20

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ADDERALL 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-008	Feb 13, 1996

International Patents for ADDERALL 20

See the table below for patents covering ADDERALL 20 around the world.

Country	Patent Number	Title	Estimated Expiration
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
European Patent Office	1202739

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ADDERALL 20

Last updated: August 2, 2025

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Introduction

ADDERALL 20, a prescription medication primarily used for treating Attention Deficit Hyperactivity Disorder (ADHD), has established a significant presence within the pharmaceutical landscape. Comprising mixed amphetamine salts, ADDERALL 20 is manufactured by Shire Pharmaceuticals and later by Takeda Pharmaceuticals following acquisitions. Its impact on the mental health treatment market, combined with regulatory, competitive, and evolving prescribing practices, influences its market dynamics and financial trajectory.

This comprehensive analysis delineates the factors impacting ADDERALL 20's market performance, projecting its financial outlook based on current trends, regulatory landscape, competition, and patent status.

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Market Overview

ADDERALL 20 has been integral to the ADHD pharmacotherapy sector, with estimated global sales exceeding $4 billion in recent years [1]. The drug’s efficacy in reducing core ADHD symptoms has cemented its status among clinicians, while its formulation—20 mg tablets—provides standardized dosing options. However, market dynamics are shifting due to increased scrutiny over stimulant medications' abuse potential, evolving regulatory policies, and competitive alternatives.

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Regulatory and Patent Environment

Regulatory agencies such as the FDA maintain stringent controls on stimulant medications. While the patent for ADDERALL has expired (last patent expiration around 2019), generic formulations swiftly entered the market, exerting downward pressure on price and sales margins [2].

Notably, patent expirations allowed multiple generics to enter the market, intensifying competition. Furthermore, regulatory bodies have implemented REMS (Risk Evaluation and Mitigation Strategies) programs to monitor misuse and diversion, adding operational costs but also reinforcing prescription controls.

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Competitive Landscape

The most significant competition comes from generic amphetamine mixed salts formulations, which capture a substantial share of the ADHD market. Additionally, non-stimulant medications like atomoxetine and guanfacine challenge ADDERALL's dominance. The rise of non-stimulant options, perceived as having lower abuse potential, influences prescribing habits.

In recent years, drug development efforts have focused on extended-release formulations and novel delivery systems, though ADDERALL remains a preferred choice in many clinical settings due to evidence-based efficacy.

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Market Trends Influencing Demand

1. Increased Awareness and Diagnosis: Rising awareness of ADHD across age groups leads to higher diagnosis rates, fueling demand. However, this growth is moderated by concerns over stimulant misuse among adolescents and young adults [3].

2. Prescribing Shifts: There has been a gradual shift towards non-stimulant options, especially in populations at higher risk of substance abuse. This influences the long-term demand for ADDERALL.

3. Regulatory Pressure: Stricter prescription monitoring programs and abuse-deterrent formulations impact distribution channels and prescribing practices, possibly reducing overprescription.

4. Telemedicine Expansion: The COVID-19 pandemic accelerated telemedicine adoption, increasing access to ADHD diagnosis and medication management, but also raising concerns about misuse, prompting tighter regulations.

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Financial Trajectory

The financial outlook for ADDERALL 20 hinges on multiple interconnected factors:

1. Revenue Stability and Growth

Despite patent expiration, ADDERALL continues to generate substantial revenue due to its entrenched place in ADHD treatment protocols. As of 2022, global sales hover around $2.8 billion, with the U.S. accounting for approximately 78% of sales [1].

Post-generic entry, revenues declined initially but stabilized, aided by brand loyalty and prescriber familiarity. As patents for specific formulations expire, the revenue share allocated to branded ADDERALL diminishes, although tight regulatory controls and brand recognition sustain its profitability.

2. Impact of Generic Competition

The entry of multiple generic brands has eroded market share and pressured prices. The price differential between brand-name and generic versions can be significant, with generics priced approximately 20-30% lower [4]. This shift has compressed profit margins for the original manufacturer, particularly in saturated markets.

3. Market Penetration in Emerging Economies

Emerging markets represent untapped growth potential. As healthcare infrastructure develops and ADHD awareness increases, demand for affordable generic formulations could surge, benefitting generic manufacturers more than branded options.

4. Innovation and Formulation Diversification

Investment in Abuse-Deterrent Formulations (ADFs) and extended-release (XR) versions can command premium pricing. However, the high R&D costs and unpredictable regulatory approval timelines pose financial risks.

5. Regulatory Decisions and Reimbursements

Reimbursement policies and formulary coverage substantially influence sales. Payers increasingly scrutinize stimulant medications for cost-effectiveness, favoring lower-cost generics. Conversely, inclusion of ADDERALL in preferred tiers benefits the brand financially.

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Forecasting the Financial Pathway

Based on the current market and regulatory environment, a conservative projection indicates:

• Short-term (1-3 years): Revenues are expected to stabilize at approximately $2.5-$2.8 billion globally, supported by ongoing prescriptions and the continued use of established formulations.

• Medium-term (3-5 years): A gradual decline of 5-10% annually is anticipated due to sustained generic competition and shifting prescriber preferences toward non-stimulant therapies. However, increased demand in underpenetrated markets could mitigate declines.

• Long-term (5+ years): Profitability depends heavily on innovation pathways, such as abuse-deterrent formulations, and regulatory landscapes. The potential introduction of digital health integrations or novel delivery systems could open new revenue streams.

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Strategic Implications for Stakeholders

• Manufacturers: Focus on differentiation through abuse-deterrent technologies, novel formulations, and expanding into emerging markets to sustain revenue streams.

• Regulators: Balancing access with control measures remains critical to prevent misuse without stifling legitimate demand.

• Payers: Prioritizing cost-effective generics and evaluation of new formulations influence overall profitability.

• Investors: Stability in brand recognition and the potential for product innovation suggest moderate long-term growth, albeit with risks associated with patent expirations and competitive pressure.

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Key Takeaways

• Market maturity and patent expirations have led to increased generic competition, exerting downward pressure on ADDERALL 20's revenue.

• Regulatory scrutiny and the rise of non-stimulant alternatives are reshaping prescribing patterns, with potential long-term impacts on market share.

• Innovation in abuse-deterrent and extended-release formulations offers opportunities for premium pricing and brand differentiation.

• Emerging markets present growth prospects due to increasing ADHD awareness and rising healthcare infrastructure investments.

• Stakeholders must adapt to evolving regulatory, competitive, and technological landscapes to sustain financial performance.

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FAQs

1. How does patent expiration affect ADDERALL 20’s market revenue?
Patent expiration allows generic manufacturers to produce equivalent formulations, increasing competition, reducing prices, and typically decreasing revenue for the original brand. While revenue declines are common post-expiry, brand loyalty and prescriber preference can temporarily stabilize sales.

2. What are the main competitive threats to ADDERALL 20?
Generic amphetamine formulations, non-stimulant medications like atomoxetine, guanfacine, and emerging non-pharmacologic therapies pose significant competitive risks, especially as prescribers consider safety and abuse potential.

3. Are there innovative formulations that could extend ADDERALL's market life?
Yes. Abuse-deterrent formulations and newer extended-release versions can justify premium pricing and restore some market share by addressing misuse concerns and improving patient compliance.

4. How might regulatory changes impact the financial trajectory of ADDERALL 20?
Tighter prescription monitoring, abuse potential restrictions, and approvals for or against high-demand formulations directly influence sales volume and revenue stability.

5. What opportunities exist in emerging markets for ADDERALL?
Growing ADHD awareness, expanding healthcare infrastructure, and increasing acceptance of stimulant therapies create opportunities for branded and generic ADDERALL sales, especially if affordability and distribution channels are optimized.

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References
[1] IQVIA, "Top Selling Drugs," 2022.
[2] FDA Patent and Exclusivity Data, 2019.
[3] CDC, "ADHD Fact Sheet," 2022.
[4] GoodRx, "ADHD Medication Pricing," 2023.