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Last Updated: April 21, 2025

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE Drug Patent Profile


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When do Dextroamp Saccharate,amp Aspartate,dextroamp Sulfate And Amp Sulfate patents expire, and when can generic versions of Dextroamp Saccharate,amp Aspartate,dextroamp Sulfate And Amp Sulfate launch?

Dextroamp Saccharate,amp Aspartate,dextroamp Sulfate And Amp Sulfate is a drug marketed by Barr Labs Inc and is included in one NDA.

The generic ingredient in DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

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Summary for DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
Drug patent expirations by year for DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE

US Patents and Regulatory Information for DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Barr Labs Inc DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076536-001 Feb 12, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Barr Labs Inc DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076536-002 Feb 12, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Barr Labs Inc DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076536-003 Feb 12, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Barr Labs Inc DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076536-004 Feb 12, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Barr Labs Inc DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076536-006 Feb 12, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  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 5 of 5 entries

Market Dynamics and Financial Trajectory for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Introduction

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, commonly known by brand names such as Adderall, are central nervous system (CNS) stimulants used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. This article delves into the market dynamics and financial trajectory of this medication.

Market Overview

The global market for ADHD medications has been growing steadily, driven by increasing diagnoses and a rising demand for effective treatments. Dextroamphetamine-based medications are among the most prescribed treatments for ADHD due to their efficacy and long-standing use.

Demand and Supply

The demand for ADHD medications, including Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, is influenced by several factors:

  • Increasing Diagnoses: The prevalence of ADHD has been on the rise, contributing to higher demand for these medications[5].
  • Treatment Compliance: Patients often require long-term treatment, ensuring a consistent demand for these drugs.
  • Generic and Branded Options: The availability of both generic and branded versions of these medications affects market dynamics, with generics often offering a more affordable alternative.

Competitive Landscape

The market for ADHD medications is highly competitive, with several key players:

  • Teva Pharmaceuticals: Known for their generic versions of Adderall.
  • Shire Pharmaceuticals: Now part of Takeda, they offer branded and extended-release versions.
  • Other Manufacturers: Companies like Sandoz and Mylan also produce generic versions.

Financial Trajectory

Revenue Trends

The revenue generated from the sale of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate has been substantial:

  • Branded vs. Generic: Branded versions, such as Adderall XR, tend to generate higher revenues due to their premium pricing. However, generic versions have been gaining market share due to their affordability[4].
  • Market Growth: The ADHD medication market has seen consistent growth, with revenues expected to continue rising as the prevalence of ADHD increases.

Pricing Strategies

Pricing plays a crucial role in the financial trajectory of these medications:

  • Branded Pricing: Branded versions are typically priced higher, which can lead to higher revenue but also faces competition from generics.
  • Generic Pricing: Generic versions are priced lower, making them more accessible but reducing profit margins per unit.

Cost Structure

The cost structure for these medications includes:

  • Research and Development: Significant investments are made in R&D for new formulations and extended-release versions.
  • Manufacturing Costs: The cost of raw materials, manufacturing processes, and quality control.
  • Marketing and Distribution: Costs associated with promoting the drug and distributing it to pharmacies and healthcare providers.

Regulatory Environment

FDA Approvals and Guidelines

The FDA plays a critical role in regulating these medications:

  • Approval Process: New formulations and generic versions must undergo rigorous testing and approval processes.
  • Safety and Efficacy: The FDA monitors the safety and efficacy of these medications, which can impact their market presence[1].

Abuse and Misuse

Given the high potential for abuse and misuse, these medications are classified as Schedule II controlled substances. This classification affects their distribution and prescribing practices, potentially impacting sales and revenue.

Side Effects and Safety Concerns

Physical and Psychological Side Effects

The side effects of these medications can influence market dynamics:

  • Common Side Effects: Include elevated mood, decreased appetite, dry mouth, and increased heart rate. More severe side effects like psychosis and cardiovascular issues can also occur[3].
  • Patient Compliance: The presence of side effects can affect patient compliance, which in turn can impact sales.

Peripheral Vasculopathy

Signs and symptoms of peripheral vasculopathy, including Raynaud’s phenomenon, have been reported. This requires careful monitoring and can lead to dosage adjustments or discontinuation, affecting the long-term use of these medications[1].

Market Projections

Future Growth

The market for ADHD medications is expected to continue growing:

  • Increasing Awareness: Greater awareness of ADHD and its treatment options is likely to drive demand.
  • New Formulations: The development of new formulations, such as extended-release versions, can attract more patients and healthcare providers.

Challenges and Opportunities

  • Generic Competition: The increasing availability of generic versions poses a challenge to branded products but also presents an opportunity for companies to expand their market share through affordable options.
  • Regulatory Changes: Changes in regulatory policies or safety guidelines can impact the market dynamics and financial trajectory of these medications.

Key Takeaways

  • Growing Demand: The demand for ADHD medications, including Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, is driven by increasing diagnoses and treatment compliance.
  • Competitive Market: The market is highly competitive with both branded and generic options available.
  • Regulatory Oversight: The medications are subject to strict regulatory oversight due to their potential for abuse and misuse.
  • Side Effects and Safety: The presence of side effects and safety concerns can impact patient compliance and long-term use.

FAQs

Q: What are the primary uses of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate?

A: These medications are primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy.

Q: What are the common side effects of these medications?

A: Common side effects include elevated mood, decreased appetite, dry mouth, and increased heart rate. More severe side effects can include psychosis and cardiovascular issues.

Q: Why are these medications classified as Schedule II controlled substances?

A: Due to their high potential for abuse and misuse, these medications are classified as Schedule II controlled substances.

Q: How does the availability of generic versions impact the market?

A: The availability of generic versions offers a more affordable alternative, which can increase market share but reduce profit margins per unit for branded products.

Q: What are the future growth prospects for these medications?

A: The market is expected to grow due to increasing awareness of ADHD, new formulations, and the ongoing need for effective treatments.

Sources

  1. Drugs.com: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets.
  2. Teva USA: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets CII.
  3. Wikipedia: Dextroamphetamine.
  4. DrugBank: Dextroamphetamine.
  5. Elsevier Healthcare Hub: Amphetamine; Dextroamphetamine.

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