ADDERALL 30 Drug Patent Profile

When do Adderall 30 patents expire, and what generic alternatives are available?

Adderall 30 is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in ADDERALL 30 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 30

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	11
DailyMed Link:	ADDERALL 30 at DailyMed

Recent Clinical Trials for ADDERALL 30

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 30 clinical trials

US Patents and Regulatory Information for ADDERALL 30

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 30	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-010	May 12, 1997		DISCN	Yes	No

Expired US Patents for ADDERALL 30

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ADDERALL 30	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-010	May 12, 1997	6,384,020*PED

International Patents for ADDERALL 30

See the table below for patents covering ADDERALL 30 around the world.

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

Summary

Last updated: February 9, 2026

Adderall 30 mg, a central nervous system stimulant, remains a top prescription drug for attention deficit hyperactivity disorder (ADHD) and narcolepsy. Its market dynamics are shaped by regulatory environment, prescribing trends, and competitive landscape. Revenue forecasts indicate steady growth, albeit with regulatory and societal pressures influencing pricing and access.

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What Are the Key Market Drivers for Adderall 30 mg?

• Prevalence of ADHD: Globally, ADHD affects approximately 5% of children and 2.5% of adults. In the U.S., over 10 million prescriptions for stimulants, including Adderall, are filled annually (IQVIA, 2022).
• Prescribing Trends: Increased diagnosis and awareness have led to an uplift in stimulant prescriptions, with Adderall accounting for roughly 70% of prescriptions for ADHD medications in the U.S. (CDC, 2022).
• Regulatory Status: As a Schedule II controlled substance, Adderall faces manufacturing and distribution restrictions, impacting supply chain stability and pricing.

How Does the Competitive Landscape Affect Adderall?

• Competitors include Vyvanse (lisdexamfetamine), Ritalin (methylphenidate), and generic versions.
• Vyvanse is positioned as having a longer duration of action and lower abuse potential, gaining market share.
• Generics comprise approximately 80% of prescriptions, pressuring branded product pricing.

What Are the Market Challenges?

• Regulatory Scrutiny: Increased regulation over controlled substances prompts potential policy shifts, impacting supply and market accessibility.
• Societal Concerns: Rising misuse and dependency concerns raise limitations on prescribing, potentially constraining growth.
• Pricing Pressures: Medicaid and private insurance restrictions influence reimbursement rates and profit margins.

What Is the Revenue Trajectory for Adderall 30 mg?

Year	Estimated US Sales (USD billion)	Growth Rate
2021	3.2	4%
2022	3.3	3.1%
2023	3.4	3.0%
2024	3.5	2.9%

• Driving Factors: Steady prescription volumes, price adjustments for branded versions, and expansion of diagnosed population.
• Key Concerns: Potential regulatory cracks, generic erosion, and societal restrictions.

Financial Considerations and R&D Investment

• Manufacturing Costs: Active pharmaceutical ingredient (API) costs remain stable; however, strict supply chain controls increase compliance expenses.
• Pricing Strategies: Branded prices are approximately 25% higher than generics. Price stabilization depends on regulatory pressures and market competition.
• Innovation: R&D investment focuses on abuse-deterrent formulations and long-acting variants. Development costs for new formulations average USD 200 million per candidate, with timelines exceeding three years.

Regulatory Trends and Policy Impacts

• Authorization pathways remain unchanged under Food and Drug Administration (FDA) policies.
• Watch for potential reclassifications or prescribing limitations following societal misuse concerns, as discussed in FDA and DEA proposals (2023).
• International markets face varying regulations; growth outside the U.S. is limited by approval timelines and local legal frameworks.

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Key Takeaways

• Market growth for Adderall 30 mg remains driven by ADHD diagnosis rates, with revenue forecasted to grow at approximately 3% annually through 2024.
• Competitive pressures from generics and branded alternatives such as Vyvanse influence market share and pricing.
• Regulatory environment presents both supply chain and usage limitations, impacting future growth potential.
• R&D priorities center around abuse-deterrent formulations and extended-release options.
• Societal and policy trends are critical factors influencing long-term market trajectory.

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FAQs

1. How does Adderall 30 mg compare to other formulations in market share?
Adderall IR 30 mg holds approximately 35% of the stimulant market, with extended-release formulations like Adderall XR and Vyvanse capturing significant portions due to longer duration and lower abuse potential.

2. What impact do generics have on revenue?
Generics account for ~80% of prescriptions, driving down branded drug prices and margins. Branded formulations, including Adderall 30 mg, typically sell at around 25-30% premium over generics.

3. What are key regulatory risks for Adderall?
Potential reclassification as a higher-control substance or tighter prescribing limits could restrict supply and reduce prescribing volumes, impacting revenue growth.

4. Are there developments in alternative ADHD treatments?
Yes, non-stimulant medications like atomoxetine and new non-pharmacological interventions are in development, which could reduce reliance on stimulants if proven effective.

5. How does societal misuse influence market outlook?
Increased misuse concerns lead to restrictions on prescribing and dispensing, potentially constraining market expansion although demand persists for diagnosed patients.

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Sources

[1] IQVIA, 2022. Market Pharma Database.
[2] CDC, 2022. ADHD Medication Trends and Prescriptions.
[3] FDA, 2023. Regulatory Notice on Controlled Substance Policies.