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Last Updated: January 1, 2025

ADDERALL 5 Drug Patent Profile


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When do Adderall 5 patents expire, and what generic alternatives are available?

Adderall 5 is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in ADDERALL 5 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 ADDERALL 5
Drug patent expirations by year for ADDERALL 5
Recent Clinical Trials for ADDERALL 5

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

SponsorPhase
Boston Children's HospitalPhase 1
Eva SzigethyPhase 4
The Beckwith InstitutePhase 4

See all ADDERALL 5 clinical trials

US Patents and Regulatory Information for ADDERALL 5

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Teva Womens ADDERALL 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 011522-009 May 12, 1997 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 1 of 1 entries

Expired US Patents for ADDERALL 5

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Teva Womens ADDERALL 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 011522-009 May 12, 1997 ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 1 of 1 entries

International Patents for ADDERALL 5

See the table below for patents covering ADDERALL 5 around the world.

CountryPatent NumberTitleEstimated Expiration
Australia 6089200 ⤷  Subscribe
Canada 2378336 ⤷  Subscribe
European Patent Office 1202739 ⤷  Subscribe
Japan 2003504406 ⤷  Subscribe
Mexico PA02000290 FORMA DE DOSIFICACION ORAL DE LIBERACION INMEDIATA RAPIDA. (RAPID IMMEDIATE RELEASE ORAL DOSAGE FORM.) ⤷  Subscribe
World Intellectual Property Organization (WIPO) 0105407 ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

ADDERALL 5 Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Adderall

Introduction to Adderall

Adderall, a trade name for the drug amphetamine, is an FDA-approved prescription medication primarily used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. It is available in both immediate-release and extended-release formulations, making it a versatile treatment option for various patient needs[1][3].

Market Size and Growth

The global Adderall drug market has been experiencing significant growth, driven largely by the increasing prevalence of ADHD. As of 2023, the market size was approximately USD 20.90 billion. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 4% between 2024 and 2032, reaching a value of around USD 29.75 billion by 2032[1][3].

Regional Market Dynamics

The market is geographically segmented into several key regions, with North America dominating the market due to the high prevalence of ADHD and advanced healthcare infrastructure. Europe is another significant market, with key players and substantial investment in research and development. The Asia Pacific region is expected to grow at the highest CAGR during the forecast period, driven by increasing awareness about ADHD and rising healthcare expenditure[1][3].

Drivers of Market Growth

Several factors are driving the growth of the Adderall market:

  • Increasing Prevalence of ADHD: The rising number of ADHD diagnoses is a primary driver, as more individuals seek medical treatment for the condition[1][3].
  • Growing Senior Population: The senior population is more predisposed to neurological illnesses, including ADHD, contributing to market expansion[1].
  • Advancements in Healthcare Infrastructure: Regions with advanced healthcare systems, such as North America and Europe, are driving market growth through better diagnosis and treatment options[3].

Challenges: The ADHD Medication Shortage

Despite the growth, the Adderall market faces significant challenges, particularly the ongoing shortage of ADHD stimulants. This shortage, which began in late 2022, has been exacerbated by several factors:

  • Manufacturing Delays: Initial manufacturing delays at pharmaceutical companies have contributed to the shortage[2].
  • Increased Demand: The back-to-school season and rising ADHD diagnoses have increased demand, further straining supply[2].
  • DEA Quotas and Regulations: Restrictions on Schedule II controlled substances, including those related to the opioid crisis, have limited the production and distribution of Adderall and other ADHD medications[2][4].
  • Supply Chain Issues: Disruptions in supply chain and manufacturing activities, partly due to the COVID-19 pandemic, have also impacted the availability of Adderall[3].

Impact on Patients and Healthcare System

The shortage has had a profound impact on patients and the healthcare system:

  • Treatment Disruptions: Many patients have had to switch medications or experience treatment disruptions, affecting their quality of life and academic performance[2].
  • Economic Burden: Patients and caregivers are spending significant time and resources to secure their medications, adding to the economic burden[2].

Economic Factors Influencing the Shortage

Economic incentives and market dynamics play a crucial role in the Adderall shortage:

  • Price Competition: Generic Adderall manufacturers compete intensely on price, which can reduce margins and make it less profitable to maintain inventory, exacerbating supply chain vulnerabilities[4].
  • Contractual Agreements: Annual contracts with pharmacy benefit managers (PBMs) or chain pharmacies can further complicate the supply chain by reducing the incentive to stockpile inventory[4].

Regulatory Responses

In response to the shortage, regulatory bodies have taken several steps:

  • DEA and FDA Actions: Letters from the DEA and FDA have encouraged manufacturers to collaborate with distributors, pharmacies, and payors to address the shortage. There has also been a re-evaluation of drug quota allotments to meet increased demand[2].
  • Legislative Efforts: Lawmakers have urged the DEA to adjust quotas and help with supply chain issues, highlighting the need for new prescription and telehealth rules[2].

Market Competition and Innovation

The Adderall market is highly competitive, with several key players focusing on developing new drugs and therapies to strengthen their market position. This competition drives innovation but also poses challenges in maintaining a stable supply chain[3].

Future Outlook

Despite the current challenges, the global Adderall drug market is expected to continue its growth trajectory. The post-pandemic period is anticipated to see a recovery in supply chain and manufacturing activities, driven by increasing demand for effective ADHD treatments. The Asia Pacific region, in particular, is expected to see significant growth due to rising healthcare expenditure and increasing awareness about ADHD[3].

Key Takeaways

  • The global Adderall market is projected to grow at a CAGR of 4% between 2024 and 2032.
  • The market is driven by the increasing prevalence of ADHD and the growing senior population.
  • North America dominates the market, followed by Europe and the Asia Pacific region.
  • The ongoing ADHD medication shortage is a significant challenge, influenced by manufacturing delays, increased demand, and regulatory restrictions.
  • Economic factors such as price competition and contractual agreements with PBMs contribute to supply chain vulnerabilities.
  • Regulatory responses and legislative efforts are underway to mitigate the shortage.

Frequently Asked Questions (FAQs)

Q: What is the primary driver of the Adderall market growth? A: The primary driver is the increasing prevalence of ADHD, along with the growing senior population predisposed to neurological illnesses[1][3].

Q: Which region dominates the Adderall market? A: North America dominates the market due to the high prevalence of ADHD and advanced healthcare infrastructure[1][3].

Q: What are the main factors contributing to the ADHD medication shortage? A: The shortage is due to manufacturing delays, increased demand, DEA quotas and regulations, and supply chain issues exacerbated by the COVID-19 pandemic[2][4].

Q: How are regulatory bodies responding to the shortage? A: Regulatory bodies are encouraging manufacturers to collaborate with distributors and re-evaluating drug quota allotments to meet increased demand[2].

Q: What is the projected market value of Adderall by 2032? A: The market is expected to reach a value of approximately USD 29.75 billion by 2032[1].

Cited Sources:

  1. Expert Market Research - Adderall Drug Market Size, Share | Industry Statistics 2032
  2. ADDitude Magazine - “A Daily Nightmare:” One Year into the ADHD Stimulant Shortage
  3. Research and Markets - Adderall Drug Market Report and Forecast 2023-2031
  4. Pharmaceutical Processing World - Understanding the economics behind the Adderall shortage

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