DEXTROAMPHETAMINE SULFATE - Generic Drug Details

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

Dextroamphetamine sulfate is the generic ingredient in six branded drugs marketed by 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 NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for dextroamphetamine sulfate. Sixteen suppliers are listed for this compound.

Summary for DEXTROAMPHETAMINE SULFATE

US Patents:	0
Tradenames:	6
Applicants:	29
NDAs:	40
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	8
Patent Applications:	6,797
Drug Prices:	Drug price trends for DEXTROAMPHETAMINE SULFATE
What excipients (inactive ingredients) are in DEXTROAMPHETAMINE SULFATE?	DEXTROAMPHETAMINE SULFATE excipients list
DailyMed Link:	DEXTROAMPHETAMINE SULFATE at DailyMed

See drug prices for DEXTROAMPHETAMINE SULFATE

Recent Clinical Trials for DEXTROAMPHETAMINE SULFATE

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

Sponsor	Phase
Vallon Pharmaceuticals, Inc.	Phase 1
Medical University of Vienna	N/A
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 2

See all DEXTROAMPHETAMINE SULFATE clinical trials

Pharmacology for DEXTROAMPHETAMINE SULFATE

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

Medical Subject Heading (MeSH) Categories for DEXTROAMPHETAMINE SULFATE

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

US Patents and Regulatory Information for DEXTROAMPHETAMINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nesher Pharms	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	209111-003	Jun 27, 2017		DISCN	No	No
Vitarine	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	084986-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sandoz	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	085371-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Tris Pharma Inc	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	206095-001	Aug 18, 2022		DISCN	No	No
Nesher Pharms	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	209111-002	Jun 27, 2017		DISCN	No	No
Able	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	076814-001	Aug 25, 2004		DISCN	No	No

DEXTROAMPHETAMINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextroamphetamine Sulfate

Introduction

Dextroamphetamine sulfate, a potent stimulant, is widely used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and certain cases of narcolepsy. The market for this drug has seen significant changes over the past decade, influenced by various factors including prescribing patterns, patient demographics, and the impact of the COVID-19 pandemic.

Overall Market Trends

From 2012 to 2022, the market for stimulant medications, including dextroamphetamine sulfate, has experienced a notable increase. According to the IQVIA Report on Stimulant Trends, the number of stimulant prescriptions dispensed in the United States increased by 45.5% from 2012 to 2021, and this trend continued into 2022[1][4].

Patient Demographics

The demographic characteristics of patients receiving dextroamphetamine sulfate have shifted over the years. There has been a significant increase in prescriptions dispensed to both male and female patients, with a higher percent increase observed among females. From 2012 to 2022, the number of prescriptions for females increased by 87.5%, while for males, it increased by 35.3%[1].

Prescriber Specialties

The specialties of prescribers have also played a crucial role in the market dynamics. Psychiatrists, pediatricians, family practice providers, and nurse practitioners are the top prescribers of stimulant medications. Notably, by 2022, nurse practitioners wrote more stimulant prescriptions than psychiatrists, with 23.4% of prescriptions coming from nurse practitioners compared to 21.8% from psychiatrists[1].

Impact of COVID-19 Pandemic

The COVID-19 pandemic had a profound impact on the dispensing of stimulant medications, including dextroamphetamine sulfate. There was a steep decline in prescriptions immediately after the pandemic restrictions were implemented in April 2020. However, by October 2020, the number of prescriptions rebounded to pre-pandemic levels and continued to increase, with the highest year-over-year increase observed between 2021 and 2022[1][4].

Telemedicine and Prescription Trends

The pandemic also accelerated the use of telemedicine for prescribing stimulants. The percentage of new therapy starts (NTS) prescribed through telemedicine visits increased dramatically from less than 1% in March 2020 to 10% in April 2020. Although this percentage declined thereafter, it remained above pre-pandemic levels throughout 2022[1][4].

Average Daily Dose (ADD) Trends

The average daily dose (ADD) of stimulant prescriptions has been a key metric in understanding prescribing patterns. From 2012 to 2022, the ADD for dextroamphetamine sulfate and other stimulants showed variations, but overall, the trend indicated a stable to slightly increasing dose over the years[1].

Product Switching and Market Share

Product switching within the stimulant market is another important aspect. Patients often switch between different stimulant products, including those containing dextroamphetamine sulfate. The report indicates that while the number of prescriptions for products containing amphetamine/dextroamphetamine continued to increase, the annual increase in 2022 was not as high as in 2021. However, prescriptions for other stimulants like methylphenidate HCl and dexmethylphenidate HCl saw higher annual increases in 2022 compared to 2021[1].

Branded vs. Generic Medications

The market share between branded and generic stimulant medications has also evolved. While branded products still hold a significant share, the trend indicates a gradual shift towards generic alternatives. From 2019 to 2022, the percentage of stimulant prescriptions dispensed for branded products showed a slight decline, although they still dominate the market[1].

Financial Trajectory

The financial trajectory of dextroamphetamine sulfate is closely tied to the overall increase in stimulant prescriptions. With a 45.5% increase in stimulant prescriptions from 2012 to 2021 and continued growth into 2022, the revenue generated from these medications has seen a substantial rise. The increased demand, particularly driven by the COVID-19 pandemic and the expanded use of telemedicine, has contributed to higher sales figures.

Co-Prescribing Trends

The co-prescribing of stimulants with other controlled substances is another financial and market dynamic. This trend, while complex and influenced by various factors, indicates a potential for increased revenue through comprehensive treatment plans that include multiple medications[1].

Challenges and Risks

Despite the financial growth, there are significant challenges and risks associated with dextroamphetamine sulfate. Misuse and addiction are major concerns, as highlighted by the potential for social isolation, deteriorating relationships, financial troubles, and psychological issues such as mania and psychosis[2].

Global Drug Market Trends

On a global scale, the market for amphetamine-type stimulants (ATS), including dextroamphetamine sulfate, is expanding. According to the UNODC, cocaine production is at a record high, and seizures of amphetamine and methamphetamine have skyrocketed, indicating growing markets and challenges in drug control[3].

Regulatory Considerations

Regulatory bodies, such as the FDA, play a crucial role in the market dynamics of dextroamphetamine sulfate. The FDA's guidelines and warnings, such as the risk of drug dependence and serious cardiovascular adverse events, influence prescribing practices and patient safety[5].

Key Takeaways

• Increasing Prescriptions: The number of stimulant prescriptions, including those for dextroamphetamine sulfate, has increased significantly from 2012 to 2022.
• Demographic Shifts: There has been a higher percent increase in prescriptions for female patients compared to male patients.
• COVID-19 Impact: The pandemic led to a temporary decline but ultimately an increase in stimulant prescriptions, aided by telemedicine.
• Financial Growth: The market has seen substantial financial growth due to increased demand.
• Challenges: Misuse, addiction, and regulatory considerations are critical factors in the market dynamics.

FAQs

Q1: What has been the trend in prescriptions for dextroamphetamine sulfate from 2012 to 2022? The number of prescriptions for dextroamphetamine sulfate has increased significantly, with a 45.5% increase in overall stimulant prescriptions from 2012 to 2021 and continued growth into 2022[1][4].

Q2: How has the COVID-19 pandemic affected the dispensing of dextroamphetamine sulfate? The pandemic led to a temporary decline in prescriptions in April 2020 but rebounded to pre-pandemic levels by October 2020, with a subsequent increase in prescriptions through 2022[1][4].

Q3: What is the role of telemedicine in the prescribing of dextroamphetamine sulfate? Telemedicine saw a significant increase during the pandemic, with the percentage of new therapy starts prescribed through telemedicine visits rising from less than 1% in March 2020 to 10% in April 2020, and remaining above pre-pandemic levels thereafter[1][4].

Q4: What are the potential risks associated with dextroamphetamine sulfate? The potential risks include misuse, addiction, social isolation, deteriorating relationships, financial troubles, and psychological issues such as mania and psychosis[2].

Q5: How do regulatory bodies influence the market for dextroamphetamine sulfate? Regulatory bodies like the FDA influence the market through guidelines and warnings about the risks of drug dependence and serious cardiovascular adverse events, which affect prescribing practices and patient safety[5].

Sources

1. IQVIA Report on Stimulant Trends from 2012-2022. Prepared for the Drug Enforcement Administration (DEA) by IQVIA Government Solutions, Inc.
2. Dexedrine Abuse | Signs of Dextroamphetamine Addiction. DrugAbuse.com.
3. World Drug Report 2022. United Nations Office on Drugs and Crime (UNODC).
4. IQVIA Report on Stimulant Trends from 2012-2021. Prepared for the Drug Enforcement Administration (DEA) by IQVIA Government Solutions, Inc.
5. ADDERALL XR™. FDA.