AMPHETAMINE - Generic Drug Details

What are the generic sources for amphetamine and what is the scope of freedom to operate?

Amphetamine is the generic ingredient in thirty-one branded drugs marketed by Neos Theraps Inc, Neos Theraps, Actavis Labs Fl Inc, Teva, Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Granules, Impax Labs, Lannett Co Inc, Lupin, Nesher Pharms, Ph Health, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Nuvo Pharm, Pharmobedient, Sandoz, Teva Pharms, Zydus Pharms, Ucb Inc, Azurity, Amneal Pharms, Bionpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Lannett, Novast Labs, Prinston Inc, Sanaluz, Senores Pharms, and Tris Pharma Inc, and is included in seventy NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine has two patent family members in two countries.

There are fifty-five drug master file entries for amphetamine. Two suppliers are listed for this compound.

Summary for AMPHETAMINE

International Patents:	2
US Patents:	20
Tradenames:	31
Applicants:	46
NDAs:	70
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	173
Patent Applications:	7,051
Drug Prices:	Drug price trends for AMPHETAMINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMPHETAMINE
What excipients (inactive ingredients) are in AMPHETAMINE?	AMPHETAMINE excipients list
DailyMed Link:	AMPHETAMINE at DailyMed

See drug prices for AMPHETAMINE

See drug sales revenues for AMPHETAMINE

Recent Clinical Trials for AMPHETAMINE

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

Sponsor	Phase
Gagan Joshi	PHASE4
Massachusetts Institute of Technology (MIT)	PHASE4
Milton S. Hershey Medical Center	PHASE4

See all AMPHETAMINE clinical trials

Pharmacology for AMPHETAMINE

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

Medical Subject Heading (MeSH) Categories for AMPHETAMINE

Adrenergic Agents

Adrenergic Uptake Inhibitors

Central Nervous System Stimulants

Dopamine Agents

Dopamine Uptake Inhibitors

Sympathomimetics

Paragraph IV (Patent) Challenges for AMPHETAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADZENYS XR-ODT	Extended-release Orally Disintegrating Tablets	amphetamine	3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg	204326	1	2016-05-10

US Patents and Regulatory Information for AMPHETAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes	8,747,902		Y
Aurolife Pharma Llc	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211639-002	Apr 17, 2019	AA	RX	No	No
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019		DISCN	Yes	No	11,160,772		Y
Sun Pharm Inds Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	215997-003	Sep 27, 2023	AB2	RX	No	No
Takeda Pharms Usa	ADDERALL XR 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	AB1	RX	Yes	No
Dr Reddys Labs Sa	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213898-001	Jul 14, 2020		DISCN	No	No
Lannett Co Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	214403-001	Nov 26, 2021	AB1	RX	No	No

International Patents for AMPHETAMINE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2726066	FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)
World Intellectual Property Organization (WIPO)	2013003622
World Intellectual Property Organization (WIPO)	2013003622
European Patent Office	2726066	FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Amphetamine

Last updated: July 28, 2025

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Introduction

Amphetamine, a central nervous system (CNS) stimulant, has a complex history rooted in medicinal use, regulatory scrutiny, and evolving market dynamics. Originally synthesized in the late 19th century, it gained prominence in the mid-20th century as a treatment for narcolepsy, ADHD, and as a stimulant for various conditions. Its pharmacological profile and misuse potential have profoundly influenced its commercial viability, regulatory status, and market trajectory. This analysis explores the current state of amphetamine’s market dynamics, future outlook, and factors shaping its financial trajectory within the pharmaceutical landscape.

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Historical Context and Pharmacological Profile

Amphetamine, chemically known as phenylpropan-2amine, was first synthesized in 1887 but remained understudied until the mid-20th century. It became widely prescribed in the 1950s and 1960s, notably under brand names such as Adderall (a mixture of amphetamine salts) and Dexedrine. Its stimulant properties increase the release of dopamine and norepinephrine, which alleviate fatigue, improve focus, and suppress appetite — traits adjunctively exploited in medical settings and illicit markets.

In the US, the Food and Drug Administration (FDA) approved amphetamine-based formulations for ADHD and narcolepsy, positioning it as a cornerstone CNS stimulant. However, the potency and abuse potential led to strict regulatory controls, including classification as a Schedule II controlled substance under the Controlled Substances Act (1970), limiting prescribing and manufacturing.

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Current Market Landscape

Market Size and Segmentation

The global stimulant drug market, with amphetamine as a core component, is valued at approximately $4.2 billion in 2023, with growth projections exceeding 5% CAGR through 2028 (source: IBISWorld). The segment primarily comprises:

• Prescription Medications: ADHD medications accounting for the largest share, driven by rising diagnosis rates. In the US, ADHD diagnoses are reported at over 6 million children and 10 million adults, fueling pharmaceutical sales (~$9 billion globally for all ADHD drugs) [1].

• Illicit Market: The non-medical misuse and trafficking of illicit amphetamine and methamphetamine pose substantial challenges, influencing regulatory and market dynamics.

Key Players and Supply Chains

Leading pharmaceutical companies, such as Teva Pharmaceuticals, Johnson & Johnson, and Alcoby, manufacture amphetamine-based formulations. Generic manufacturers dominate due to patent expirations, reducing costs and expanding access. Notably, illicit production often surpasses legal supplies, especially in regions with lax controls, impacting drug availability and market regulation.

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Regulatory and Legal Dynamics

Legal Controls and Impact

The Schedule II status imposes strict prescription protocols, including limitations on refills and mandated DEA registration for manufacturers, distributors, and dispensers. This regulatory framework constrains rapid market expansion but maintains a degree of stability for licensed producers.

Patent Expiry and Generic Competition

Patent cliffs have led to increased generic penetration, reducing prices and profit margins for branded formulations. For instance, Adderall XR patents expired in 2023 in the US, prompting intensified generic launches, diluting revenue streams.

Emerging Regulations and Oversight

In response to rising misuse, authorities globally have tightened controls. Recent measures include large-scale interdictions, prescription monitoring programs, and restrictions on non-medical uses, all impacting supply and demand dynamics.

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Market Drivers

Growing Diagnostic Rates

Enhanced awareness, reduced stigma, and diagnostic criteria updates have increased ADHD diagnoses, notably among adults. This demographic shift amplifies demand for prescription stimulants, including amphetamine formulations.

Medical Therapeutic Research

Research exploring novel formulations (e.g., extended-release, transdermal patches) and combination therapies aims to optimize efficacy and minimize abuse potential, thus positively influencing market growth.

Institutional and Military Use

Certain military and institutional applications continue to use regulated doses of amphetamine for alertness and performance enhancement, though these are niche markets.

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Constraints and Challenges

Abuse and Misuse

Non-medical use leads to societal and regulatory concerns, prompting restrictions that limit market expansion. The illicit trade not only challenges public health but also affects legitimate sales.

Regulatory Risks

Stringent oversight may lead to scheduling adjustments, manufacturing restrictions, or even bans in certain jurisdictions, contingent on misuse trends and public health findings.

Market Saturation and Price Erosion

Patent expirations and rising generic competition lead to erosion of high-margin sales, demanding efficiency gains and diversification strategies from manufacturers.

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Financial Trajectory Outlook

Short-term Outlook (1-3 years)

In the near term, financial performance is projected to stabilize with moderate growth driven by increased ADHD diagnosis rates and new formulations. However, patent expirations and pricing pressures could temper revenue growth.

Medium-term Outlook (3-5 years)

The advent of novel formulations and improved delivery systems could offset declining revenues from traditional products. Regulatory tightening may moderately inhibit growth but also create barriers against illicit market expansion, indirectly supporting licensed product markets.

Long-term Outlook (5+ years)

The market may witness decreased growth in traditional amphetamine formulations due to regulatory constraints and societal shifts toward non-stimulant therapies for ADHD (such as Atomoxetine and Guanfacine). Nonetheless, niche markets—such as performance enhancement or special medical applications—may sustain some revenue streams.

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Innovations and Future Opportunities

• Alternative Delivery Systems: Transdermal patches, long-acting formulations, and injectable variants aim to improve compliance and reduce abuse potential, promising incremental market growth.

• Digital Monitoring and Abuse Deterrents: Integration of digital adherence tools and abuse-deterrent formulations could mitigate misuse, fostering a more sustainable market environment.

• Regulatory Approvals in Emerging Markets: Expanding access in underserved regions, with appropriate regulatory safeguards, offers growth opportunities, especially where ADHD awareness is increasing.

• Biotech Developments: Ongoing research into non-stimulant alternatives with similar efficacy but lower abuse potential could impact long-term demand for traditional amphetamines.

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Conclusion

Amphetamine's market dynamics hinge on balancing therapeutic demand with societal concerns over misuse. While regulatory constraints and patent cliffs challenge traditional revenue streams, ongoing medical innovation and expanding diagnostic criteria sustain a stable growth trajectory. Strategic positioning in research, formulation innovation, and compliance will be pivotal for pharmaceutical companies aiming to capitalize on this evolving landscape.

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Key Takeaways

• The amphetamine market remains significant, with global revenues around $4.2 billion, driven chiefly by ADHD prescriptions.
• Patent expirations and generic competition are exerting downward pressure on prices, necessitating innovation.
• Regulatory oversight continues to tighten, especially concerning misuse, impacting supply and affordability.
• Growing diagnosis rates and novel formulations present growth opportunities—particularly in emerging markets.
• The future landscape may favor non-stimulant and abuse-deterrent formulations, possibly diminishing traditional amphetamine-based revenues.

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FAQs

1. How does regulatory status influence the amphetamine market?
Regulatory controls, notably Schedule II classification, impose strict prescribing and manufacturing limitations, reducing illicit use but also constraining rapid market expansion. Tight controls can lead to shortages or decreased availability, influencing supply and pricing.

2. What are the main drivers of recent growth in the amphetamine market?
Increased ADHD diagnosis rates globally, the development of new formulations with improved delivery mechanisms, and expanding awareness all contribute to steady growth despite regulatory hurdles.

3. How do patent expirations affect market revenues?
Patent expirations enable generic manufacturers to launch cheaper versions, reducing prices and profit margins for branded products. This often results in revenue declines for original patent holders unless offset by new formulations or indications.

4. What role does illicit amphetamine trade play in market dynamics?
Illicit trade increases societal risks, prompts stricter regulations, and can disrupt legal supply chains—challenging manufacturers and regulators to balance access with misuse prevention.

5. What innovations are likely to shape the future of amphetamine-based therapies?
Development of abuse-deterrent formulations, long-acting delivery systems, and non-stimulant alternatives will influence future market dynamics, potentially reshaping demand patterns.

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Sources
[1] IBISWorld. "Global ADHD Medications Market Analysis," 2023.