DEXTROAMPHETAMINE - Generic Drug Details

What are the generic sources for dextroamphetamine and what is the scope of patent protection?

Dextroamphetamine is the generic ingredient in seven branded drugs marketed by Noven Pharms Inc, Impax Labs Inc, Able, Actavis Elizabeth, Dr Reddys Labs Sa, Nesher Pharms, Norvium Bioscience, Specgx Llc, Strides Pharma, Teva, Glaxosmithkline, Prasco, Tris Pharma Inc, Ani Pharms, Aurolife Pharma Llc, Avanthi Inc, Azurity, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, Winder Labs Llc, Shire, and Ferndale Labs, and is included in forty-one NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dextroamphetamine has thirty-three patent family members in twelve countries.

There are eighteen drug master file entries for dextroamphetamine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for DEXTROAMPHETAMINE

International Patents:	33
US Patents:	6
Tradenames:	7
Applicants:	30
NDAs:	41
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	32
Patent Applications:	6,647
Drug Prices:	Drug price trends for DEXTROAMPHETAMINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXTROAMPHETAMINE
What excipients (inactive ingredients) are in DEXTROAMPHETAMINE?	DEXTROAMPHETAMINE excipients list
DailyMed Link:	DEXTROAMPHETAMINE at DailyMed

See drug prices for DEXTROAMPHETAMINE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DEXTROAMPHETAMINE

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SYSTEM;TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DEXTROAMPHETAMINE

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

Sponsor	Phase
The Beckwith Institute	Phase 4
Eva Szigethy	Phase 4
Vallon Pharmaceuticals, Inc.	Phase 1

See all DEXTROAMPHETAMINE clinical trials

Generic filers with tentative approvals for DEXTROAMPHETAMINE

Applicant	Application No.	Strength	Dosage Form
		30MG	CAPSULE, EXTENDED RELEASE;ORAL
		25MG	CAPSULE, EXTENDED RELEASE;ORAL
		20MG	CAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DEXTROAMPHETAMINE

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

US Patents and Regulatory Information for DEXTROAMPHETAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022		RX	Yes	No	9,456,993		Y
Winder Labs Llc	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	212160-002	Jun 7, 2021	AA	RX	No	No
Nuvo Pharm	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	210059-002	Oct 18, 2017	AA	RX	No	No

International Patents for DEXTROAMPHETAMINE

Country	Patent Number	Title	Estimated Expiration
Peru	20060491	DISPOSITIVO TRANSDERMICO DE TRANSMISION DE FARMACO QUE INCLUYE UN REFUERZO OCLUSIVO
Mexico	2007004315	DISPOSITIVO PARA SUMINISTRO TRANSDERMICO DE FARMACO QUE INCLUYE UN RESPALDO OCLUSIVO. (TRANSDERMAL DRUG DELIVERY DEVICE INCLUDING AN OCCLUSIVE BACKING.)
European Patent Office	4274555	COMPOSITIONS TRANSDERMIQUES D'AMPHÉTAMINE À FAIBLES TAUX DE CARBAMATE (TRANSDERMAL AMPHETAMINE COMPOSITIONS WITH LOW LEVELS OF CARBAMATE)

DEXTROAMPHETAMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextroamphetamine

Introduction

Dextroamphetamine, a potent central nervous system (CNS) stimulant, is widely used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. The market dynamics and financial trajectory of this drug are influenced by several factors, including regulatory policies, demand trends, and supply chain issues.

Demand Trends

Increasing Diagnoses and Prescription Rates

The demand for dextroamphetamine, particularly in the form of Adderall and other amphetamine derivatives, has been on the rise due to increasing diagnoses of ADHD. Studies have shown that the number of people receiving ADHD medication prescriptions has been growing, with over 40 million prescriptions in 2020 alone[4].

Age-Specific Demand

Demand varies across different age groups. Adults over 18 years old have higher average fill rates for amphetamine/dextroamphetamine prescriptions compared to children. However, the rate of prescription fills for adults decreased significantly between 2022 and 2023, with a 12.4% drop, while children saw a 10.3% decrease[4].

Supply Chain Issues

Current Shortage

The market for dextroamphetamine has been severely impacted by a persistent shortage that began in October 2022. This shortage, initially affecting Adderall, has since extended to other ADHD medications like Vyvanse and Ritalin. The primary cause of this shortage is attributed to the DEA's strict quota system on dextroamphetamine production, which limits manufacturers' ability to meet the growing demand[1].

Impact of DEA Quotas

Despite the DEA raising the Aggregate Production Quota (APQ) for dextroamphetamine by 18%, only about 25% of this increased quota is allocated for domestic use. This results in a mere 6.5% rise in lisdexamfetamine supply, which is insufficient to bridge the supply gap given the 6% increase in demand from 2023 to 2024[1].

Manufacturing and Raw Material Challenges

Initially, the shortage was also attributed to manufacturing and raw material shortages. However, pharmaceutical companies have clarified that they are producing as much as the DEA permits, highlighting the DEA's quota system as the main bottleneck[1].

Financial Implications

Market Impact

The shortage has significant financial implications for both patients and healthcare providers. Patients face increased costs and reduced access to essential medications, while healthcare providers struggle with the logistical and financial burdens of managing the shortage. The financial strain is exacerbated by the need for alternative treatments and the potential for increased hospitalizations due to untreated ADHD[1][4].

Revenue and Sales

The financial trajectory of dextroamphetamine is complex due to the interplay between increasing demand and supply constraints. While the demand for ADHD medications is rising, the shortage limits the potential revenue growth for manufacturers. For instance, despite being the 14th most commonly prescribed medication in the U.S. in 2022, the sales of Adderall and similar medications have been hampered by the shortage[3][4].

Regulatory Environment

DEA Policies

The DEA's quota system is a critical factor influencing the market dynamics of dextroamphetamine. Critics argue that the DEA's policies are overly restrictive and fail to account for the growing need for ADHD medications, particularly among adults. There is a growing call for the DEA to overhaul its quota system to better align with patient needs[1].

FDA and Other Agencies

The FDA and other regulatory agencies have also played a role in managing the shortage. The FDA has announced efforts to increase the availability of certain formulations, but these measures have been insufficient to fully address the shortage[4].

Clinical and Social Benefits

Health Outcomes

The use of dextroamphetamine and other ADHD medications is associated with several beneficial health outcomes. These include fewer hospitalizations for psychiatric and nonpsychiatric morbidity, lower suicidal behavior, and reduced work disability. Studies have shown that medications like lisdexamfetamine and dexamphetamine significantly decrease the risk of psychiatric hospitalization, nonpsychiatric hospitalization, and suicide attempts[2].

Economic Benefits

While the direct financial benefits of dextroamphetamine sales are impacted by the shortage, the long-term economic benefits of treating ADHD effectively are substantial. Reduced hospitalizations, lower rates of work disability, and improved mental health outcomes all contribute to significant economic savings and improved productivity[2].

Misuse and Addiction Concerns

Risk of Misuse

Dextroamphetamine has a high potential for misuse due to its euphoric and energizing effects. This misuse can lead to serious side effects, including addiction, psychosis, and cardiovascular issues. The risk of misuse highlights the need for strict regulatory oversight and responsible prescribing practices[3][5].

Treatment and Recovery

Treating addiction to dextroamphetamine involves medical detoxification, primary treatment, and aftercare. However, there are currently no FDA-approved drugs for treating addiction to CNS stimulants, making management challenging[5].

Future Outlook

Addressing the Shortage

To address the ongoing shortage, there is a pressing need for the DEA to reassess its quota system and allocate more resources for domestic use. Manufacturers and regulatory agencies must work together to ensure that production meets the growing demand for ADHD medications[1].

Market Growth

Despite current challenges, the market for dextroamphetamine is expected to grow as the prevalence of ADHD continues to rise. Efforts to improve supply chain efficiency and regulatory adjustments could lead to increased revenue and sales for manufacturers in the future[4].

Key Takeaways

• Increasing Demand: The demand for dextroamphetamine is rising due to increasing ADHD diagnoses.
• Supply Chain Issues: The DEA's quota system is the primary cause of the current shortage.
• Financial Implications: The shortage affects both patients and healthcare providers financially.
• Regulatory Environment: The DEA's policies need to be revised to meet growing demand.
• Clinical Benefits: Dextroamphetamine use is associated with improved health and economic outcomes.
• Misuse Concerns: The drug has a high potential for misuse and addiction.

FAQs

What is the primary cause of the current dextroamphetamine shortage?

The primary cause of the current dextroamphetamine shortage is the DEA's strict quota system on dextroamphetamine production, which limits manufacturers' ability to meet the growing demand[1].

How does the DEA's quota system impact the supply of dextroamphetamine?

The DEA's quota system restricts the amount of dextroamphetamine that can be produced, resulting in a supply gap that cannot keep up with the increasing demand for ADHD medications[1].

What are the health benefits associated with the use of dextroamphetamine?

The use of dextroamphetamine is associated with fewer hospitalizations for psychiatric and nonpsychiatric morbidity, lower suicidal behavior, and reduced work disability[2].

What are the risks associated with the misuse of dextroamphetamine?

Misuse of dextroamphetamine can lead to serious side effects, including addiction, psychosis, and cardiovascular issues. It also poses risks such as structural cardiac abnormalities and long-term cognitive deficits[3][5].

How is the shortage affecting patients and healthcare providers financially?

The shortage increases costs for patients and healthcare providers due to reduced access to essential medications, the need for alternative treatments, and potential increases in hospitalizations due to untreated ADHD[1][4].

What steps are needed to address the ongoing shortage of dextroamphetamine?

Addressing the shortage requires the DEA to reassess its quota system and allocate more resources for domestic use. Manufacturers and regulatory agencies must work together to ensure production meets the growing demand for ADHD medications[1].

Sources

1. US ADHD Stimulant Shortage Highlights Growing Challenges in Adult Treatment. AJMC. November 27, 2024.
2. Attention-Deficit/Hyperactivity Disorder Medications and Work Disability and Mental Health Outcomes. JAMA Netw Open. March 20, 2024.
3. Dextroamphetamine. Wikipedia.
4. The Adderall shortage: Exploring rates of prescription fills over time. Truveta. April 2, 2024.
5. Dexedrine Misuse: Side Effects, Withdrawal, and Recovery. Greenhouse Treatment. July 16, 2024.