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, Endo Operations, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, 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, Norvium Bioscience, Nuvo Pharm, Oryza, 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 sixty-nine NDAs. There are twenty-one 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. One supplier is listed for this compound.

Summary for AMPHETAMINE

International Patents:	2
US Patents:	21
Tradenames:	31
Applicants:	46
NDAs:	69
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	167
Patent Applications:	6,517
Drug Prices:	Drug price trends for AMPHETAMINE
Drug Sales Revenues:	Drug sales revenues 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
University of Zurich	Phase 1
Stephen Robert Marder	Phase 2
Virginia Commonwealth University	Phase 2

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
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019		DISCN	Yes	No			Y
Aurolife Pharma Llc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	202424-003	Nov 27, 2013	AB	RX	No	No
Specgx Llc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	211546-002	Aug 31, 2023	AB2	RX	No	No

International Patents for AMPHETAMINE

Country	Patent Number	Title	Estimated Expiration
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)

AMPHETAMINE Market Analysis and Financial Projection Experimental

Amphetamine Drug Market: Dynamics and Financial Trajectory

Introduction

The amphetamine drug market is poised for significant growth, driven by a combination of factors including increasing prevalence of central nervous system disorders, government support, and advancements in drug development. Here, we delve into the market dynamics, growth drivers, challenges, and the financial trajectory of the amphetamine drug market.

Market Size and Growth Projections

The amphetamine drug market is expected to witness a lucrative growth rate between 2024 and 2036. This growth is attributed to the rising number of people suffering from various disorders such as Attention Deficit Hyperactivity Disorder (ADHD), narcolepsy, obesity, and depression[1][4].

Growth Drivers

Increased Prevalence of Disorders

The surge in central nervous system disorders, sleeping disorders, and depression cases is a significant driver of the market. The global increase in the prevalence of depression among adults and children is particularly noteworthy, with the depression segment anticipated to dominate the market[1].

Government Support and Approvals

Government approvals and the commercialization of new drugs by market players are crucial factors driving market growth. Governments around the world are supporting the ADHD drug market to address the growing number of patients with these conditions[1].

Research and Development

Increased research and development activities, along with the simultaneous approval of new drugs, are also driving the market forward. Collaborations among key market players to enhance product development and commercialization further boost market growth[1][4].

Market Segmentation

By Application

The amphetamine drug market is segmented into ADHD, narcolepsy, obesity, depression, and other applications. The depression segment is expected to dominate due to the increasing prevalence of depression globally[1].

By Demographics

The market is bifurcated into children and adults, with the adult segment anticipated to hold the largest share. This is due to the larger adult patient population[1].

By Distribution Channel

The market is also segmented by distribution channels, including retail pharmacies, hospitals, and online platforms. Retail pharmacies are expected to play a significant role in the distribution of amphetamine drugs[4].

By Region

The global amphetamine drug market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is predicted to dominate the majority of the revenue share by 2036, followed by Europe and the Asia Pacific region[1][4].

Regional Analysis

North America

North America is expected to dominate the market due to the high prevalence of depression and ADHD patients. Collaborations among market players and efforts to increase market penetration for product development and commercialization are key factors contributing to this dominance[1].

Europe

Europe is anticipated to hold the second-largest market share, driven by the presence of major pharmaceutical companies and increasing awareness about mental health in the region[1].

Asia Pacific

The Asia Pacific region is expected to expand at a higher rate during the forecast period due to the increasing demand for drugs to treat various disorders such as ADHD[1].

Challenges

Regulatory Hurdles

Strict regulations and the illegal use of amphetamine drugs pose significant challenges to the market. For instance, seizures of amphetamine and methamphetamine have skyrocketed, indicating stringent control measures[1][3].

Social and Environmental Factors

Individual, social, and environmental factors influence the use trajectory of amphetamine-type stimulants. These include reasons for initiation, continuation, increase, and decrease in use, such as managing stress, social belonging, and financial instability[2].

Financial Trajectory

Revenue Growth

The market is projected to see substantial revenue growth driven by the increasing demand for amphetamine drugs. The CAGR for the retail pharmacy segment, for example, is expected to be significant during the forecast period[4].

Market Share

Key players in the market are expected to maintain and expand their market share through strategic collaborations, research and development, and effective commercialization strategies[1][4].

Impact of Illegal Use

Global Control Measures

The illegal use of amphetamine drugs is being strictly controlled globally. Seizures of amphetamine pills have been reported in various regions, highlighting the efforts to curb illegal trafficking[1][3].

Consumer Behavior and Health Impacts

Addiction and Health Risks

The use of amphetamine drugs, especially for non-medical purposes, can lead to addiction and severe health risks. Users often experience increased tolerance, withdrawal effects, and negative health impacts, which can affect their long-term well-being[2][3].

Case Studies

Personal accounts, such as the one from a finance professional who experienced career downfall due to Adderall use, highlight the potential professional and personal risks associated with dependency on these drugs[5].

Key Takeaways

• The amphetamine drug market is expected to grow significantly between 2024 and 2036.
• The market is driven by the increasing prevalence of central nervous system disorders, government support, and advancements in drug development.
• North America is predicted to dominate the market, followed by Europe and the Asia Pacific region.
• Strict regulations and the illegal use of amphetamine drugs pose challenges to the market.
• Individual, social, and environmental factors significantly influence the use trajectory of amphetamine-type stimulants.

FAQs

Q: What are the primary drivers of the amphetamine drug market? A: The primary drivers include the increasing prevalence of central nervous system disorders, government support, and advancements in drug development.

Q: Which region is expected to dominate the amphetamine drug market? A: North America is expected to dominate the majority of the revenue share by 2036.

Q: What are the challenges faced by the amphetamine drug market? A: The market faces challenges such as strict regulations, illegal use of amphetamine drugs, and the influence of individual, social, and environmental factors on drug use trajectories.

Q: How does the illegal use of amphetamine drugs impact the market? A: The illegal use of amphetamine drugs is being strictly controlled globally, with significant seizures reported, which can affect market dynamics and consumer behavior.

Q: What are the potential health risks associated with amphetamine drug use? A: The use of amphetamine drugs can lead to addiction, increased tolerance, withdrawal effects, and negative health impacts, affecting long-term well-being.

Sources

1. Research Nester, "Amphetamine Drug Market Size & Share, Growth Analysis 2036".
2. PubMed, "Which individual, social and environmental influences shape key phases in the amphetamine type stimulant use trajectory?"
3. UNODC, "DRUG MARKET TRENDS 2022".
4. Cognitive Market Research, "Amphetamine Drug Market Report 2024 (Global Edition)".
5. Wall Street Oasis, "How Adderall ruined my career in finance".