ADDERALL XR 20 Drug Patent Profile

Which patents cover Adderall Xr 20, and what generic alternatives are available?

Adderall Xr 20 is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ADDERALL XR 20 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 XR 20

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
Patent Applications:	1
DailyMed Link:	ADDERALL XR 20 at DailyMed

Recent Clinical Trials for ADDERALL XR 20

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

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

See all ADDERALL XR 20 clinical trials

Pharmacology for ADDERALL XR 20

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for ADDERALL XR 20

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001	AB1	RX	Yes	No

Expired US Patents for ADDERALL XR 20

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001
Takeda Pharms Usa	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001
Takeda Pharms Usa	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001
Takeda Pharms Usa	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001

International Patents for ADDERALL XR 20

See the table below for patents covering ADDERALL XR 20 around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0023055
Canada	2348090	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
European Patent Office	1977736
Spain	2323910
European Patent Office	1123087	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
Australia	1214500
Japan	2008303223	ORAL PULSED DOSE DRUG DELIVERY SYSTEM

ADDERALL XR 20 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Adderall XR

Introduction to Adderall XR

Adderall XR, a central nervous system (CNS) stimulant, is a widely used medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. It is a mixed salt of a single-entity amphetamine product, comprising Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate[1][4][5].

Market Size and Growth

The global market for Adderall, including its extended-release version Adderall XR, is substantial and growing. 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% from 2024 to 2032, reaching a value of about USD 29.75 billion by 2032[3].

Regional Market Presence

The Adderall market is predominantly driven by North America, which accounts for the largest share. Other significant regions include Latin America, the Middle East and Africa, Europe, and the Asia Pacific. The rising prevalence of ADHD and an increasing senior population predisposed to neurological illnesses are key drivers of market expansion in these regions[3].

Generic Market and Competition

Adderall XR, including its generic versions, has an estimated IQVIA market value of approximately $1.3 billion for the 12 months ending in recent years. However, actual generic market values are expected to be lower due to competition from multiple generic suppliers. Lannett Company, Inc., for example, has entered into agreements with Elite Pharmaceuticals and SunGen Pharma to distribute generic Adderall XR, further increasing the competitive landscape[1][4][5].

Product Launches and Distribution

Lannett Company, Inc. has been actively expanding its product portfolio, including the launch of generic Adderall XR. In March 2020, Lannett commenced marketing a generic version of Adderall XR in capsule form, with strengths ranging from 5 mg to 30 mg. This move is part of Lannett's broader strategy to bring more affordable medicines to patients, despite the presence of several generic suppliers in the market[1][4].

Clinical Efficacy and Patient Satisfaction

Studies have shown that Adderall XR is highly effective in controlling ADHD symptoms over extended periods. A two-year, open-label trial conducted by Harvard Medical School investigators found significant long-term ADHD symptom control in adult patients treated with once-daily Adderall XR. Patients demonstrated a significant average reduction in their ADHD symptoms, and the treatment exhibited a good tolerability profile[2].

Side Effects and Tolerability

While Adderall XR is generally well-tolerated, common side effects include dry mouth, insomnia, loss of appetite, headache, and nervousness. These side effects are typically mild or moderate and tend to diminish over time. The body may also develop tolerance to Adderall, necessitating periodic dose adjustments by medical practitioners[2].

Regulatory and Legal Aspects

Adderall is classified as a Schedule II prohibited drug, requiring a prescription for purchase. This regulatory status underscores the controlled nature of the medication due to its potential for abuse and dependence[3].

Financial Performance and Projections

The financial trajectory of Adderall XR is influenced by its market size, competition, and regulatory environment. With an estimated market value of $1.3 billion for Adderall XR and its generic versions, the product remains a significant contributor to the revenues of pharmaceutical companies like Lannett. The projected growth in the ADHD treatment market, driven by increasing prevalence rates, suggests a stable and potentially growing financial performance for Adderall XR in the coming years[1][3][5].

Strategic Alliances and Distribution Agreements

Lannett's strategic alliances with Elite Pharmaceuticals and SunGen Pharma have been crucial in securing FDA approval and distributing generic Adderall XR. These partnerships enable Lannett to provide sales, marketing, and distribution support, ensuring a robust market presence and revenue share from the profits[1][4][5].

Consumer and Market Trends

The rising prevalence of ADHD and the increasing awareness of the condition are driving consumer demand for effective treatments like Adderall XR. Additionally, the preference for extended-release formulations due to their convenience and efficacy is a trend that supports the market growth of Adderall XR[3].

Key Takeaways

• Market Size and Growth: The global Adderall market, including Adderall XR, is expected to grow from USD 20.90 billion in 2023 to USD 29.75 billion by 2032.
• Generic Competition: Multiple generic suppliers, including Lannett, are active in the market, contributing to a competitive landscape.
• Clinical Efficacy: Adderall XR has been shown to be highly effective in controlling ADHD symptoms over extended periods.
• Regulatory Status: Adderall is a Schedule II prohibited drug, requiring a prescription.
• Financial Performance: The product is a significant revenue contributor, with an estimated market value of $1.3 billion for Adderall XR and its generic versions.

FAQs

Q: What is the primary use of Adderall XR? A: Adderall XR is primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Q: Who are the key players in the Adderall XR market? A: Key players include Shire Plc, the original developer, and generic suppliers like Lannett Company, Inc., Elite Pharmaceuticals, and SunGen Pharma.

Q: What is the estimated market value of Adderall XR and its generic versions? A: The estimated market value is approximately $1.3 billion for the 12 months ending in recent years.

Q: What are the common side effects of Adderall XR? A: Common side effects include dry mouth, insomnia, loss of appetite, headache, and nervousness.

Q: Why is Adderall classified as a Schedule II drug? A: Adderall is classified as a Schedule II drug due to its potential for abuse and dependence.