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Last Updated: April 7, 2025

Amphetamine; amphetamine aspartate/dextroamphetamine sulfate - Generic Drug Details


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

Amphetamine; amphetamine aspartate/dextroamphetamine sulfate is the generic ingredient in five branded drugs marketed by Tris Pharma Inc and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine; amphetamine aspartate/dextroamphetamine sulfate has twenty-one patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for amphetamine; amphetamine aspartate/dextroamphetamine sulfate
International Patents:21
US Patents:10
Tradenames:5
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
DailyMed Link:amphetamine; amphetamine aspartate/dextroamphetamine sulfate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for amphetamine; amphetamine aspartate/dextroamphetamine sulfate
Generic Entry Dates for amphetamine; amphetamine aspartate/dextroamphetamine sulfate*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;ORAL
Generic Entry Dates for amphetamine; amphetamine aspartate/dextroamphetamine sulfate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*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.

Pharmacology for amphetamine; amphetamine aspartate/dextroamphetamine sulfate
Paragraph IV (Patent) Challenges for AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DYANAVEL XR 5 Extended-release Tablets amphetamine; amphetamine aspartate/dextroamphetamine sulfate 5 mg, 10 mg, 15 mg and 20 mg 210526 1 2025-01-22

US Patents and Regulatory Information for amphetamine; amphetamine aspartate/dextroamphetamine sulfate

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Tris Pharma Inc DYANAVEL XR amphetamine; amphetamine aspartate/dextroamphetamine sulfate SUSPENSION, EXTENDED RELEASE;ORAL 208147-001 Oct 19, 2015 RX Yes Yes 11,590,228 ⤷  Try for Free Y ⤷  Try for Free
Tris Pharma Inc DYANAVEL XR amphetamine; amphetamine aspartate/dextroamphetamine sulfate SUSPENSION, EXTENDED RELEASE;ORAL 208147-001 Oct 19, 2015 RX Yes Yes 8,747,902 ⤷  Try for Free Y ⤷  Try for Free
Tris Pharma Inc DYANAVEL XR 5 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-001 Nov 4, 2021 RX Yes No 11,590,081 ⤷  Try for Free Y ⤷  Try for Free
Tris Pharma Inc DYANAVEL XR 10 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-002 Nov 4, 2021 RX Yes No 11,590,081 ⤷  Try for Free Y ⤷  Try for Free
Tris Pharma Inc DYANAVEL XR 20 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-004 Nov 4, 2021 RX Yes Yes 8,747,902 ⤷  Try for Free Y ⤷  Try for Free
Tris Pharma Inc DYANAVEL XR 20 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-004 Nov 4, 2021 RX Yes Yes 11,590,081 ⤷  Try for Free Y ⤷  Try for Free
Tris Pharma Inc DYANAVEL XR 20 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-004 Nov 4, 2021 RX Yes Yes 9,675,704 ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

International Patents for amphetamine; amphetamine aspartate/dextroamphetamine sulfate

CountryPatent NumberTitleEstimated Expiration
Austria E536867 ⤷  Try for Free
Brazil PI0709606 formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica ⤷  Try for Free
Russian Federation 2435569 КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN) ⤷  Try for Free
South Korea 101495146 ⤷  Try for Free
Spain 2396039 ⤷  Try for Free
Spain 2378573 ⤷  Try for Free
Taiwan 200812649 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Market Dynamics and Financial Trajectory of Amphetamine Drugs: Amphetamine and Amphetamine Aspartate/Dextroamphetamine Sulfate

Introduction

Amphetamine drugs, including amphetamine and amphetamine aspartate/dextroamphetamine sulfate, are crucial in the treatment of various central nervous system disorders, most notably Attention Deficit Hyperactivity Disorder (ADHD), narcolepsy, and depression. This article delves into the market dynamics and financial trajectory of these drugs, highlighting key drivers, challenges, and future outlook.

Market Size and Growth

The amphetamine drug market is projected to experience a lucrative growth rate between 2024 and 2036. This growth is driven by increased research and development activities, along with the simultaneous approval of new drugs. The rising prevalence of central nervous system disorders, sleeping disorders, and depression, coupled with growing consumer awareness about mental health, are significant factors contributing to market expansion[1][4].

Growth Drivers

Increased Prevalence of CNS Disorders

The surge in cases of ADHD, narcolepsy, and depression has led to a higher demand for amphetamine drugs. Governments worldwide are supporting the development and commercialization of these drugs to address these conditions effectively[1].

Government Approvals and Commercialization

Government approvals and collaborations among market players to enhance product development and commercialization are key drivers. For instance, the FDA approval of DYANAVEL XR, an amphetamine extended-release formulation, has significantly impacted the market[3].

Consumer Awareness and Mental Health

Growing awareness about mental health issues has led to increased diagnosis and treatment rates, further boosting the demand for amphetamine drugs[1][3].

Market Segmentation

By Application

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

By Demographics

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

By Distribution Channel

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

By Region

North America is predicted to dominate the market, followed by Europe and the Asia Pacific region. The presence of a high number of depression and ADHD patients, along with collaborations among key players, drives the growth in North America[1].

Financial Performance and Revenue

Prescription Rates and Insurance Coverage

The financial performance of amphetamine drugs, such as DYANAVEL XR, is influenced by prescription rates, insurance coverage, and market competition. Steady growth in prescriptions, driven by clinical efficacy and expanding treatment markets, has been observed[3].

Pricing and Reimbursement

The pricing strategy for these drugs is critical. They are generally priced competitively with other ADHD treatments, and reimbursement by major insurance providers helps maintain a strong market presence. However, pricing can be a barrier for some patients, necessitating careful navigation to balance profitability with patient access[3].

Product Forms and Approvals

DYANAVEL XR

DYANAVEL XR, an amphetamine extended-release formulation, is available in two forms: an extended-release oral suspension and extended-release tablets. The FDA approvals in 2015 and 2021 for these forms have expanded treatment options for patients, contributing to the drug's market appeal[3].

Regulatory Environment

FDA Approvals and Compliance

The regulatory environment, including FDA approvals and compliance with manufacturing standards, is essential for maintaining market presence. Any compliance issues can impact production and sales, highlighting the importance of stringent regulatory adherence[3].

Challenges

Illicit Use and Control Measures

The illicit use of amphetamine drugs is a significant challenge. Strict global control measures are in place to combat the illegal use of these substances. For example, joint operations by law enforcement agencies have resulted in significant seizures of amphetamine pills[1][2].

Limited Therapeutic Usefulness

Historically, the therapeutic usefulness of amphetamine-type stimulants has been recognized as limited, leading to more stringent control measures. Despite this, clandestine manufacture and abuse have continued to be issues[2].

Future Outlook

Growing Demand for ADHD Treatments

The future outlook for amphetamine drugs is promising, driven by the growing demand for ADHD treatments. The commitment to further research and development, as well as potential expansion into new patient populations, could enhance market position and financial performance[3].

Technological Advancements

Technological advancements, such as the LiquiXR® platform technology used in DYANAVEL XR, provide once-daily dosing options that combine immediate and extended release characteristics, improving patient compliance and treatment efficacy[3].

Key Takeaways

  • The amphetamine drug market is expected to grow significantly between 2024 and 2036.
  • Increased prevalence of CNS disorders, government approvals, and consumer awareness are key growth drivers.
  • The adult demographic segment is expected to hold the largest market share.
  • North America is predicted to dominate the market, followed by Europe and the Asia Pacific region.
  • Regulatory compliance and managing illicit use are critical challenges.
  • Technological advancements and expanding treatment options are expected to enhance market position and financial performance.

FAQs

What are the primary applications of amphetamine drugs?

Amphetamine drugs are primarily used for treating ADHD, narcolepsy, obesity, and depression, with the depression segment anticipated to dominate the market[1].

Which region is expected to dominate the amphetamine drug market?

North America is predicted to dominate the majority of the revenue share by 2036 due to the presence of a higher number of depression and ADHD patients[1].

What are the key factors affecting the financial performance of amphetamine drugs?

The financial performance is influenced by prescription rates, insurance coverage, market competition, and pricing strategies. Regulatory compliance and managing illicit use are also critical factors[3].

How has the regulatory environment impacted the market?

FDA approvals and compliance with manufacturing standards are essential for maintaining market presence. Any compliance issues can impact production and sales, highlighting the importance of stringent regulatory adherence[3].

What technological advancements are enhancing the market position of amphetamine drugs?

Technological advancements such as the LiquiXR® platform technology used in DYANAVEL XR provide once-daily dosing options, combining immediate and extended release characteristics, which improve patient compliance and treatment efficacy[3].

Sources

  1. Research Nester, "Amphetamine Drug Market Size & Share, Growth Analysis 2036," 2023.
  2. UNODC, "AMPHETAMINE-TYPE STIMULANTS A GLOBAL REVIEW," 1996.
  3. Drug Patent Watch, "DYANAVEL XR Drug Patent Profile," 2023.
  4. Cognitive Market Research, "Amphetamine Drug Market Report 2024 (Global Edition)," 2023.
  5. American Journal of Public Health, "America's First Amphetamine Epidemic 1929–1971," 2011.

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