DEXTROSTAT Drug Patent Profile

Which patents cover Dextrostat, and what generic alternatives are available?

Dextrostat is a drug marketed by Shire and is included in one NDA.

The generic ingredient in DEXTROSTAT is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dextrostat

A generic version of DEXTROSTAT was approved as dextroamphetamine sulfate by BARR on January 31^st, 2001.

Summary for DEXTROSTAT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	17
DailyMed Link:	DEXTROSTAT at DailyMed

US Patents and Regulatory Information for DEXTROSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire	DEXTROSTAT	dextroamphetamine sulfate	TABLET;ORAL	084051-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Shire	DEXTROSTAT	dextroamphetamine sulfate	TABLET;ORAL	084051-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Dextrostat

Introduction

Dextrostat, a brand name for the medication dextroamphetamine, is a central nervous system stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Understanding the market dynamics and financial trajectory of Dextrostat involves analyzing prescription trends, pricing changes, and the impact of external factors such as the COVID-19 pandemic.

Prescription Trends for Stimulants

From 2012 to 2022, the number of stimulant prescriptions, including those for Dextrostat, has shown a significant increase. According to the IQVIA Report, the projected number of stimulant prescriptions dispensed rose by 57.9%, from 50.4 million in 2012 to 79.6 million in 2022[4].

Demographic Shifts

• The 31-40-year age group saw a substantial increase in stimulant prescriptions, more than doubling since 2012. This age group's share of all stimulant prescriptions increased from 10.1% in 2012 to 21.9% in 2021[1].
• Females experienced a higher percentage increase in stimulant prescriptions compared to males, with a 69.5% increase for females versus a 27.5% increase for males from 2012 to 2021[1].

Prescriber Specialties

• Psychiatrists and pediatricians were the top prescribers of stimulants, although their prescription volumes have either declined or remained stable. However, prescriptions from nurse practitioners have more than tripled since 2012[1][4].

Impact of the COVID-19 Pandemic

The COVID-19 pandemic had a notable impact on the dispensation of stimulant medications, including Dextrostat.

Initial Decline and Rebound

• From April to May 2020, there was a steep decline in stimulant prescriptions immediately after the U.S. implemented COVID-19 restrictions. However, by October 2020, prescription levels rebounded to pre-pandemic levels and subsequently saw the highest year-over-year increase between 2020 and 2021[1][4].

Telemedicine

• The use of telemedicine for stimulant prescriptions, including New Therapy Starts (NTS), increased dramatically during the pandemic. By April 2020, telemedicine accounted for 10% of NTS prescriptions, although this percentage declined to 5.4% by the end of 2022. Despite this decline, telemedicine usage remained above pre-pandemic levels[1][4].

Pricing Trends

Recent Price Changes

• In recent months, there have been significant price changes in the pharmaceutical market. For ADHD medications, including those containing dextroamphetamine, prices have generally decreased. For example, in September 2024, dextroamphetamine/amphetamine ER doses saw price decreases ranging from -17.1% to -19.3%, and lisdexamfetamine doses decreased by -18.1% to -23.7%[3].

Generic Drug Deflation

• Year-over-year generic oral solid deflation has been observed, with a 7.2% deflation rate in September 2024. This trend indicates a decline in the costs of generic drugs, which can positively impact the financial trajectory of medications like Dextrostat[3].

Financial Implications

Revenue Impact

• Despite the increase in prescription volumes, the financial impact of Dextrostat can be influenced by pricing changes. Decreases in prices, such as the -32.1% decrease for dextroamphetamine in September 2024, can reduce revenue even if the number of prescriptions increases[3].

Market Competition

• The market for ADHD medications is competitive, with both branded and generic options available. The most dispensed stimulant molecules in 2022 were amphetamine/dextroamphetamine, which includes Dextrostat. However, competition from other medications and the increasing use of generic alternatives can affect market share and revenue[4].

Co-Prescribing Trends

Controlled Substances

• Stimulants, including Dextrostat, are sometimes co-prescribed with other controlled substances. The IQVIA report highlights that there has been an increase in such co-prescriptions, which can have implications for patient safety and treatment efficacy[4].

Safety and Efficacy Studies

Poststroke Motor Recovery

• A study published in JAMA Neurology found that dextroamphetamine combined with physiotherapy did not improve poststroke motor recovery compared to placebo combined with physiotherapy. This study underscores the importance of evidence-based prescribing practices and the need for continuous research on the efficacy of stimulants in various clinical contexts[2].

Key Takeaways

• Increasing Prescription Volumes: Stimulant prescriptions, including those for Dextrostat, have increased significantly from 2012 to 2022.
• Pandemic Impact: The COVID-19 pandemic led to a temporary decline in prescriptions but also accelerated the use of telemedicine, which has remained above pre-pandemic levels.
• Pricing Trends: Recent price decreases for ADHD medications, including dextroamphetamine, can impact revenue despite increased prescription volumes.
• Market Competition: The competitive landscape, including generic alternatives, influences the market share and revenue of Dextrostat.
• Co-Prescribing Trends: There is an increasing trend of co-prescribing stimulants with other controlled substances, which requires careful monitoring.

FAQs

1. What was the impact of the COVID-19 pandemic on Dextrostat prescriptions?

   • The pandemic led to a temporary decline in prescriptions but also saw a rebound to pre-pandemic levels by October 2020, with a subsequent increase in prescriptions[1][4].

2. How have price changes affected Dextrostat in recent months?

   • Prices for dextroamphetamine-containing medications have decreased significantly, with some doses seeing price reductions of up to -32.1% in September 2024[3].

3. Which age groups have seen the most significant increase in stimulant prescriptions?

   • The 31-40-year age group has seen a more than doubling of stimulant prescriptions since 2012[1].

4. What is the trend in generic drug prices?

   • Year-over-year generic oral solid deflation has been observed, with a 7.2% deflation rate in September 2024, indicating a decline in costs[3].

5. Did dextroamphetamine improve poststroke motor recovery in a clinical trial?

   • No, a study found that dextroamphetamine combined with physiotherapy did not improve poststroke motor recovery compared to placebo combined with physiotherapy[2].

Sources

1. IQVIA Report on Stimulant Trends from 2012 - 2021 - U.S. Department of Justice, Drug Enforcement Administration.
2. Effect of Dextroamphetamine on Poststroke Motor Recovery - JAMA Neurology.
3. The latest spooky, scary drug price changes - 46brooklyn Research.
4. IQVIA Report on Stimulant Trends from 2012 - 2022 - U.S. Department of Justice, Drug Enforcement Administration.