ADDERALL 15 Drug Patent Profile

Which patents cover Adderall 15, and what generic alternatives are available?

Adderall 15 is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in ADDERALL 15 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.

Summary for ADDERALL 15

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
Patent Applications:	1
DailyMed Link:	ADDERALL 15 at DailyMed

Recent Clinical Trials for ADDERALL 15

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

Sponsor	Phase
Boston Children's Hospital	Phase 1
The Beckwith Institute	Phase 4
Eva Szigethy	Phase 4

See all ADDERALL 15 clinical trials

US Patents and Regulatory Information for ADDERALL 15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Womens	ADDERALL 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-013	Aug 31, 2000		DISCN	Yes	No

Expired US Patents for ADDERALL 15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ADDERALL 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-013	Aug 31, 2000

International Patents for ADDERALL 15

See the table below for patents covering ADDERALL 15 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2003504406
Australia	6089200
World Intellectual Property Organization (WIPO)	0105407

ADDERALL 15 Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Adderall

Introduction

Adderall, a medication primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD), has been at the center of significant market and supply chain disruptions. This article delves into the current market dynamics, financial trajectory, and the various factors influencing the Adderall market.

Increasing Prevalence of ADHD

The demand for Adderall is driven largely by the increasing prevalence of ADHD. Over the past two decades, the diagnosis rate of ADHD has risen substantially, with college students seeing a particularly sharp increase from 2% to nearly 12%[1].

Market Growth and Projections

The global Adderall drug market is expected to witness significant growth during the forecast period of 2023-2031. Driven by the increasing prevalence of ADHD and the growing adoption of stimulant medications, the market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4% and reach a value of USD 28.61 billion by 2031[3].

Regional Market Analysis

• North America: This region dominates the Adderall market, driven by the high prevalence of ADHD and advanced healthcare infrastructure. The U.S. and Canada are key markets, with a strong presence of major pharmaceutical companies[3].
• Europe: Europe is another significant market, with key players investing heavily in research and development. The region's well-established healthcare system supports the demand for Adderall[3].
• Asia Pacific: This region is expected to grow at the highest CAGR during the forecast period, driven by increasing awareness about ADHD and rising healthcare expenditure. Countries like China, Japan, and India are emerging as key markets[3].

Supply Chain Disruptions and Shortages

The Adderall market has been plagued by supply chain disruptions and shortages. The COVID-19 pandemic exacerbated these issues, leading to production delays and worker shortages at key manufacturers like Teva Pharmaceuticals[1][4].

Impact on Generic Drugs

While brand-name Adderall products are generally available, generic manufacturers are struggling to meet demand. The shortage of raw materials, particularly lisdexamfetamine, has hindered the production of generic versions of Vyvanse and other ADHD medications[4].

FDA and DEA Regulations

The FDA and DEA have played crucial roles in the ongoing shortage. The DEA's maintenance of low production quotas despite rising demand has contributed to the shortage. Additionally, restrictions related to the opioid crisis have further complicated the situation for patients and prescribers[5].

Financial Impact

The financial trajectory of the Adderall market is complex, influenced by both demand and supply factors.

Revenue Projections

Despite the current shortages, the market is expected to continue its growth trajectory. The estimated market value is projected to increase from USD 20.9 billion in 2022 to USD 28.61 billion by 2031[3].

Manufacturer Challenges

Manufacturers face significant challenges in meeting the demand. For instance, Teva Pharmaceuticals, a major producer of Adderall, continues to see unprecedented demand but faces production and distribution hurdles[4].

Patient and Market Feedback

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

Patient Struggles

Patients have reported significant difficulties in accessing their prescribed medications. Many have had to switch to different medications or formulations, which can be less effective or more undesirable[5].

Economic Burden

The shortage has imposed a substantial economic burden on patients and caregivers. The time and resources spent on finding alternative medications and managing treatment disruptions are considerable[5].

Industry Response and Future Outlook

The industry is working to address the current shortages through various measures.

Increased Production

Manufacturers are ramping up production to meet the growing demand. However, the availability of raw materials and the capacity to scale up production remain significant challenges[4].

Regulatory Support

The FDA and other regulatory bodies are actively working with manufacturers to track and mitigate drug shortages. This includes daily monitoring of supply chain data and collaborating with manufacturers to ensure adequate supply[4].

Key Takeaways

• Increasing Demand: The demand for Adderall is driven by the rising prevalence of ADHD.
• Supply Chain Issues: The market is facing significant supply chain disruptions, including production delays and raw material shortages.
• Regulatory Challenges: FDA and DEA regulations, particularly those related to the opioid crisis, have exacerbated the shortage.
• Financial Growth: Despite current challenges, the Adderall market is projected to grow significantly over the next decade.
• Patient Impact: The shortage has had a profound impact on patients, leading to treatment disruptions and economic burdens.

FAQs

1. Why is there a shortage of Adderall? The shortage is due to a combination of factors including production delays, worker shortages, and supply chain disruptions exacerbated by the COVID-19 pandemic. Additionally, increased demand and regulatory restrictions have contributed to the shortage[1][4].

2. How is the Adderall market expected to grow? The global Adderall drug market is expected to grow at a CAGR of 4% and reach a value of USD 28.61 billion by 2031, driven by the increasing prevalence of ADHD and growing adoption of stimulant medications[3].

3. Which regions are key markets for Adderall? North America, Europe, and the Asia Pacific region are the key markets for Adderall, with North America dominating the market due to its high prevalence of ADHD and advanced healthcare infrastructure[3].

4. How have regulatory bodies responded to the shortage? The FDA and DEA are actively working with manufacturers to track and mitigate drug shortages. This includes daily monitoring of supply chain data and collaborating with manufacturers to ensure adequate supply[4].

5. What are the economic and patient impacts of the shortage? The shortage has imposed significant economic burdens on patients and caregivers, who spend considerable time and resources finding alternative medications and managing treatment disruptions. Patients have also reported difficulties in accessing their prescribed medications, leading to treatment disruptions and decreased quality of life[5].

Sources

1. BU Articles: "What's Behind the Adderall Shortage and What Does It Mean for Patients?" - Boston University.
2. Wall Street Oasis: "How Adderall ruined my career in finance" - Wall Street Oasis.
3. Research and Markets: "Adderall Drug Market Report and Forecast 2023-2031" - Research and Markets.
4. CBS News: "Why is there an ADHD medication shortage in 2024? What's making it so hard to get Adderall?" - CBS News.
5. ADDitude Magazine: “A Daily Nightmare:” One Year into the ADHD Stimulant Shortage - ADDitude Magazine.