AMPHETAMINE SULFATE - Generic Drug Details

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

Amphetamine sulfate is the generic ingredient in three branded drugs marketed by Azurity, Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Sanaluz, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in eighteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for amphetamine sulfate. Thirteen suppliers are listed for this compound.

Summary for AMPHETAMINE SULFATE

US Patents:	4
Tradenames:	3
Applicants:	17
NDAs:	18
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	8
Patent Applications:	1,596
Drug Prices:	Drug price trends for AMPHETAMINE SULFATE
What excipients (inactive ingredients) are in AMPHETAMINE SULFATE?	AMPHETAMINE SULFATE excipients list
DailyMed Link:	AMPHETAMINE SULFATE at DailyMed

See drug prices for AMPHETAMINE SULFATE

Recent Clinical Trials for AMPHETAMINE SULFATE

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

Sponsor	Phase
Vallon Pharmaceuticals, Inc.	Phase 1
Arbor Pharmaceuticals, Inc.	Phase 3
Sarah Morrow	Phase 2/Phase 3

See all AMPHETAMINE SULFATE clinical trials

Pharmacology for AMPHETAMINE SULFATE

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

US Patents and Regulatory Information for AMPHETAMINE SULFATE

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	10,130,580		Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019		DISCN	Yes	No	11,160,772		Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019		DISCN	Yes	No	11,896,562
Alkem Labs Ltd	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213720-002	Oct 27, 2020	AA	RX	No	No
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019		DISCN	Yes	No	10,441,554		Y

Expired US Patents for AMPHETAMINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021	10,130,580
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019	10,130,580
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019	10,130,580
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019	10,130,580
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019	10,130,580

AMPHETAMINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amphetamine Sulfate

Introduction

Amphetamine sulfate, a central nervous system (CNS) stimulant, is widely used in the treatment of various conditions, including attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity. The market for amphetamine sulfate is influenced by a complex interplay of factors, including medical needs, regulatory environments, and economic trends.

Market Size and Growth Projections

The amphetamine drug market, which includes amphetamine sulfate, is projected to experience significant growth over the next decade. From 2024 to 2036, the market is expected to witness a lucrative growth rate, driven by several key factors[3].

• Increasing Prevalence of CNS Disorders: The rising number of people suffering from central nervous system disorders such as ADHD, narcolepsy, and depression is a major driver. Government support and increased awareness about mental health are also contributing to market growth.
• Research and Development: Continuous research and development activities, along with the approval of new drugs, are further boosting the market.
• Regional Analysis: North America is anticipated to dominate the market share due to the high prevalence of depression and ADHD. Europe and the Asia Pacific region are also expected to see significant growth, driven by the presence of major pharmaceutical companies and increasing demand for treatments[3].

Application Segments

The amphetamine drug market is segmented by application, with key segments including:

• ADHD: This remains one of the primary applications for amphetamine sulfate, given its efficacy in reducing the core symptoms of ADHD such as hyperactivity, inattention, and impulsivity[5].
• Narcolepsy: Amphetamine sulfate is used to manage excessive daytime sleepiness associated with narcolepsy.
• Obesity: Although less common, amphetamine sulfate can be prescribed for weight loss in certain cases.
• Depression: The depression segment is anticipated to dominate the market in the coming years due to the increasing prevalence of depression among adults and children[3].

Demographic Segments

The market is also segmented by demographics, with the adult segment expected to hold the largest share. This is attributed to a larger adult patient population compared to children[3].

Distribution Channels

The distribution of amphetamine sulfate is primarily through prescription channels, with a significant portion of prescriptions written by psychiatrists, pediatricians, family practice providers, and nurse practitioners. In recent years, nurse practitioners have written a higher percentage of stimulant prescriptions than psychiatrists[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of amphetamine sulfate. Strict controls on the prescription and distribution of amphetamine-based drugs are in place to prevent misuse and addiction. For instance, the U.S. has implemented stringent regulations on pharmaceutical precursors to curb the illicit manufacture of amphetamines[1].

Financial Implications

The financial trajectory of the amphetamine sulfate market is influenced by several factors:

• Government Support: Governments around the world are supporting the development and commercialization of ADHD drugs, which includes amphetamine sulfate. This support is expected to drive market growth[3].
• Commercialization of New Drugs: The approval and commercialization of new amphetamine-based drugs by market players are anticipated to increase revenue in the market.
• Collaborations and Partnerships: Collaborations among key market players to increase market penetration and product development are expected to boost the market growth, particularly in regions like North America and Europe[3].

Challenges and Risks

Despite the growth projections, the market faces several challenges:

• Misuse and Addiction: The risk of misuse and addiction associated with amphetamine sulfate is a significant concern. High doses can lead to serious side effects, including psychosis and cognitive impairment[5].
• Illicit Use: The illicit use of amphetamines, including those diverted from legitimate medical channels, poses a challenge to the legal market. Efforts to control precursor chemicals and manufacturing operations are ongoing to mitigate this issue[1].
• Compliance and Regulation: Strict regulatory requirements can impact the availability and accessibility of amphetamine sulfate, affecting market dynamics.

Global Seizures and Trafficking

The illicit market for amphetamines, including those used to manufacture amphetamine sulfate, is a global concern. According to the UNODC, there has been a significant increase in the seizures of amphetamine-type stimulants (ATS) worldwide. This includes methamphetamine, which accounts for a large portion of ATS seizures. The trafficking of precursor chemicals and finished products continues to shift to vulnerable locations with weaker enforcement and forensic infrastructure[1].

Societal and Health Impacts

The use of amphetamine sulfate, both legally and illicitly, has significant societal and health impacts:

• Health Consequences: Long-term use of amphetamines can lead to multiple comorbidities, including HIV infection, hepatitis, cardiac effects, cognitive dysfunction, and psychiatric consequences such as psychosis[2].
• Societal Costs: The abuse of amphetamines is associated with premature death, crime, lost productivity, environmental damage, disruption of family life, and infectious diseases[2].

Treatment and Prevention

Despite the challenges, there is a growing focus on treatment and prevention:

• Psychosocial Therapies: While pharmacotherapy for methamphetamine or amphetamine-type stimulant dependency is limited, psychosocial therapies have shown some efficacy. However, real-world impact is often limited by poor retention rates and treatment adherence[2].
• Prevention: Early prevention is key, with a focus on addressing the complex dynamic of individual, social, and environmental factors that contribute to drug use trajectories[2].

Key Takeaways

• The amphetamine sulfate market is expected to grow significantly from 2024 to 2036, driven by increasing CNS disorders and government support.
• The market is segmented by application, demographics, and distribution channels, with the adult segment and ADHD treatment being major drivers.
• Regulatory environments and compliance issues are critical factors influencing market dynamics.
• The illicit use and trafficking of amphetamines pose significant challenges to the legal market.
• Health and societal impacts of amphetamine use are substantial, highlighting the need for effective treatment and prevention strategies.

FAQs

Q: What are the primary applications of amphetamine sulfate? A: Amphetamine sulfate is primarily used in the treatment of ADHD, narcolepsy, and obesity.

Q: Which region is expected to dominate the amphetamine drug market? A: North America is anticipated to dominate the market share due to the high prevalence of depression and ADHD.

Q: What are the major challenges facing the amphetamine sulfate market? A: The market faces challenges such as misuse and addiction, illicit use, and strict regulatory requirements.

Q: How does the illicit use of amphetamines impact the legal market? A: Illicit use diverts resources from legitimate medical channels and poses a challenge to market dynamics, requiring stringent controls on precursor chemicals and manufacturing operations.

Q: What are the health consequences associated with long-term amphetamine use? A: Long-term use can lead to multiple comorbidities, including HIV infection, hepatitis, cardiac effects, cognitive dysfunction, and psychiatric consequences such as psychosis.

Sources

1. UNODC: "Amphetamine-type stimulants market" - World Drug Report 2009.
2. O'Donnell et al.: "Which individual, social and environmental influences shape key phases in the ATS use trajectory?" - Addiction, 2018.
3. ResearchNester: "Amphetamine Drug Market Size & Share, Growth Analysis 2036".
4. DEA: "IQVIA Report on Stimulant Trends from 2012 - 2022".
5. Wikipedia: "Amphetamine".