ADDERALL 10 Drug Patent Profile

When do Adderall 10 patents expire, and when can generic versions of Adderall 10 launch?

Adderall 10 is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in ADDERALL 10 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 10

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADDERALL 10
DailyMed Link:	ADDERALL 10 at DailyMed

Recent Clinical Trials for ADDERALL 10

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 10 clinical trials

US Patents and Regulatory Information for ADDERALL 10

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 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-007	Feb 13, 1996		DISCN	Yes	No

Expired US Patents for ADDERALL 10

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ADDERALL 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-007	Feb 13, 1996	6,384,020*PED

International Patents for ADDERALL 10

See the table below for patents covering ADDERALL 10 around the world.

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

Market Dynamics and Financial Trajectory for ADDERALL 10

Last updated: September 30, 2025

Introduction

ADDERALL 10, a widely prescribed psychostimulant primarily containing mixed amphetamine salts, remains a cornerstone in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. As a branded and generic product, its market behavior and financial outlook are influenced by evolving pharmaceutical regulations, generational shifts in ADHD diagnosis, and competitive dynamics in the stimulant therapy segment. This analysis explores the market forces shaping ADDERALL 10’s trajectory and forecasts its financial prospects over the coming years.

Current Market Landscape

Global and U.S. Market Valuation

The global ADHD therapeutics market, valued at approximately $11 billion in 2022, is projected to grow at a CAGR of 6.5% through 2030[1]. The United States dominates this sector, accounting for over 70% of the global market share, driven by high diagnosis rates and a preference for stimulant medications such as ADDERALL.

Within the U.S., ADDERALL remains the top-prescribed medication for ADHD, with an estimated 8 million prescriptions annually[2]. Its broad acceptance stems from clinical efficacy, familiarity among healthcare providers, and insurance coverage.

Competitive Environment

ADDERALL faces competition from several counterpart stimulants, including Vyvanse, Concerta, and Dexedrine, as well as non-stimulant options like Strattera. The introduction of generic formulations significantly impacts market share and pricing, intensifying price competition but expanding accessibility.

Regulatory and Prescriptive Trends

The FDA’s ongoing scrutiny of stimulant abuse potential influences prescription behaviors. Recent policies emphasize cautious prescribing practices, particularly among adolescents. Nonetheless, the robust clinical data supporting ADDERALL sustains its demand, especially in severe cases.

Market Dynamics Influencing ADDERALL 10

1. Prescriber and Consumer Adoption Patterns

Physician preference remains high for ADDERALL due to its well-documented efficacy and rapid onset of action. However, rising concerns over abuse liability and regulatory constraints push prescribers towards alternative formulations with abuse-deterrent features. Consumer perceptions also evolve, especially in the context of increasing awareness of dependency risks.

2. Pricing and Reimbursement Landscape

The transition from branded to generic formulations has profoundly affected ADDERALL 10’s financial dynamics. Generic versions, introduced approximately a decade ago, now dominate sales, driving down unit costs but reducing revenue margins for original manufacturers. Insurance reimbursement policies favor generics, further cementing their market share.

3. Patent and Intellectual Property Considerations

While the original ADDERALL patent expired in 2007, formulation patents protecting specific extended-release versions momentarily limited generic competition. Current formulations, including ADDERALL 10, benefit from patent protections that influence market exclusivity timelines.

4. Manufacturing and Supply Chain Components

Supply chain stability affects market supply and pricing. Recent global disruptions, including the COVID-19 pandemic, temporarily constrained ingredient availability, influencing production costs and delivery timelines.

5. Regulatory and Abuse-Deterrent Innovations

Emerging formulations incorporating abuse-deterrent technologies, such as crush-resistant tablets or extended-release mechanisms, impact prescribing patterns. Although ADDERALL 10 remains the standard, competition from abuse-deterrent generics influences its market share.

Financial Trajectory Analysis

Revenue Trends and Forecasting

ADDERALL’s revenues have plateaued in recent years due to market saturation and increased generic penetration. In 2022, the U.S. branded ADDERALL segment generated approximately $2.5 billion, with generics accounting for over 80% of total sales[3].

Forecasts suggest a slight decline in branded ADDERALL revenues over the next five years, owing to patent expirations and intensifying generic competition. However, the overall ADHD drug market’s growth mitigates this decline, offsetting revenue losses from branded products through increased volume sales of generics.

Impact of Generics and Pricing

The average price of ADDERALL 10 mg tablets decreased by approximately 35% following the proliferation of generics in 2010-2012. Continued price erosion is expected, reflecting typical dynamics in mature pharmaceutical markets. Nevertheless, the high-volume nature of the ADHD segment sustains profitability, especially for large manufacturers with cost-efficient production methods.

Profitability Outlook

Margins on branded formulations are expected to decline further, whereas generics and biosimilar formulations present opportunities for maintaining profitability. Companies investing in abuse-deterrent formulations may command premium pricing, fostering shifts in profit centers.

Upcoming Patent Expirations and Market Opportunities

Patent expirations slated for 2024-2025 might catalyze increased generic entry, further compressing prices. Conversely, innovations in formulation technology and expanded indications (e.g., adult ADHD, off-label uses) could offset some revenue erosion.

Potential Disruptions: Policy and Public Health

Regulatory actions aimed at curtailing stimulant abuse could influence prescribing behaviors and, consequently, revenue streams. Conversely, improvements in abuse-deterrent technology and expanded access may sustain or elevate revenue levels.

Future Outlook and Strategic Considerations

Market Expansion Opportunities

• Adult ADHD Market: Growing recognition of adult ADHD diagnoses expands the target demographic for ADDERALL, potentially increasing per-patient treatment duration and volume.
• Emerging Markets: Increasing diagnosis awareness and healthcare infrastructure development in Asia-Pacific and Latin America open new revenue streams.

Research and Development Pipelines

Developments in non-stimulant therapies and novel delivery systems could threaten ADDERALL’s market share unless pharmaceutical companies evolve their offerings.

Regulatory and Policy Risks

Heightened prescribing restrictions, supply chain disruptions, or adverse regulatory actions could hamper growth prospects. Proactive engagement with policymakers and continued innovation are essential.

Key Takeaways

• Market Maturity and Competition: The ADDERALL 10 market is mature, with sustained demand driven by its proven efficacy. Generics dominate sales, exerting downward pressure on prices and margins.
• Revenue Outlook: While branded revenues are plateauing and expected to decline post-patent expiration, overall ADHD market growth offers revenue sustainability.
• Strategic Innovation: Abusing-deterrent formulations and expansion into adult demographics present avenues to offset generic competition. Significant investment in R&D can secure future revenue streams.
• Regulatory Environment: Staying ahead of policy shifts is critical. Emphasizing responsible prescribing and abuse mitigation strategies aids market stability.
• Emerging Market Growth: Focused expansion in emerging economies and adult segments offers long-term growth prospects.

FAQs

1. How will generic competition influence ADDERALL 10's market share in the coming years?
Generic entries after patent expirations significantly diminish branded sales and reduce profit margins. However, the overall demand for stimulant therapy is projected to grow due to increasing ADHD diagnoses, partly offsetting market share erosion.

2. Are there emerging formulations of ADDERALL to counter abuse?
Yes. New formulations incorporating abuse-deterrent technologies are in development or approved, aimed at reducing misuse and expanding market appeal, especially in sensitive populations.

3. What role do regulatory policies play in the future of ADDERALL 10?
Regulations targeting abuse potential, prescribing guidelines, and potential scheduling adjustments can impact demand. Proactive compliance and innovation are critical to maintaining market access.

4. Can expanding into adult ADHD markets sustain ADDERALL’s revenues?
Increasing recognition and diagnosis of adult ADHD provide a lucrative growth avenue. Higher per-patient treatment durations and increased prescribing boost revenues.

5. How might global market trends affect ADDERALL's financial trajectory?
Emerging markets with expanding healthcare infrastructure and increasing awareness offer substantial opportunities. Conversely, global regulatory tightening and public health measures targeting stimulant misuse may pose challenges.

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References

[1] MarketWatch. (2022). ADHD Therapeutics Market Size & Share, Growth, Trends.
[2] IQVIA. (2022). Prescription Drug Data Report.
[3] EvaluatePharma. (2022). Annual Pharmaceutical Market Trends.