ADDERALL XR 5 Drug Patent Profile

Which patents cover Adderall Xr 5, and what generic alternatives are available?

Adderall Xr 5 is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ADDERALL XR 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.

Summary for ADDERALL XR 5

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 5 at DailyMed

Recent Clinical Trials for ADDERALL XR 5

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 5 clinical trials

Pharmacology for ADDERALL XR 5

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

US Patents and Regulatory Information for ADDERALL XR 5

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 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-005	May 22, 2002	AB1	RX	Yes	No

Expired US Patents for ADDERALL XR 5

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ADDERALL XR 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-005	May 22, 2002	6,322,819*PED
Takeda Pharms Usa	ADDERALL XR 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-005	May 22, 2002	RE42096*PED
Takeda Pharms Usa	ADDERALL XR 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-005	May 22, 2002	RE41148*PED
Takeda Pharms Usa	ADDERALL XR 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-005	May 22, 2002	6,605,300*PED

International Patents for ADDERALL XR 5

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0023055
Germany	69940673
Austria	427101
European Patent Office	1977736
Japan	2008303223	ORAL PULSED DOSE DRUG DELIVERY SYSTEM
Canada	2348090	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
European Patent Office	1123087	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)

ADDERALL XR 5 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Adderall XR

Introduction

Adderall XR, a central nervous system (CNS) stimulant, is a widely used medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Developed by Shire Plc, the drug has been a significant player in the pharmaceutical market, influencing both the financial performance of its manufacturers and the broader ADHD treatment landscape.

Market Uptake and Revenue Growth

In the early 2000s, Adderall XR saw substantial market uptake, contributing significantly to Shire's revenue growth. For instance, in the first quarter of 2008, Shire reported a 37% year-on-year increase in pharmaceutical sales, with Adderall XR driving much of this growth. The drug generated $261.5 million in sales during this period, a 5% increase from the previous year, despite a 5% decline in U.S. prescriptions[2].

Competitive Landscape

The ADHD market is highly competitive, with several drugs vying for market share. The introduction of new treatments, such as Vyvanse (lisdexamfetamine dimesylate), has impacted Adderall XR's market dominance. Despite this, Adderall XR remained a key revenue generator for Shire, although its market share did decline. By the first quarter of 2008, Adderall XR's share of the U.S. ADHD market had fallen to 23.7% due to the entry of Vyvanse[2].

Generic Competition

The expiration of patents and the subsequent entry of generic versions have significantly altered the financial trajectory of Adderall XR. In 2013, Shire agreed to pay Impax $48 million to settle claims related to the supply of an authorized generic version of Adderall XR. This settlement allowed Impax to continue selling the authorized generic and plan for its own generic version pending FDA approval[5].

In 2019 and 2020, Lannett Company, Inc. announced the commencement and subsequent launch of a generic version of Adderall XR, further increasing competition in the market. Lannett's generic version is available in various strengths and is part of a broader strategy to offer more affordable medicines to patients[1][4].

Financial Impact

The introduction of generic versions has had a profound financial impact on Shire and other original manufacturers. By the third quarter of 2012, sales of Adderall XR had already declined by 32% due to generic competition from companies like Actavis (a subsidiary of Watson)[5].

Despite this, the generic market for Adderall XR remains substantial. As of 2020, the estimated IQVIA market value for Adderall XR and its generic versions was approximately $1.3 billion for the 12 months ending January 2020, although actual generic market values were expected to be lower[4].

Pricing and Market Value

The pricing of Adderall XR has been a critical factor in its market dynamics. In the first quarter of 2008, the price increase of the drug contributed to its revenue growth, even as the number of prescriptions declined. However, with the entry of generics, pricing pressure has increased, leading to a reduction in the overall market value of the branded drug[2].

Strategic Alliances and Distribution

To navigate the changing market landscape, companies have formed strategic alliances. Lannett, for example, entered into an agreement with Elite Pharmaceuticals and SunGen Pharma to be the exclusive U.S. distributor of generic Adderall XR, among other products. This alliance allows Lannett to provide sales, marketing, and distribution support while sharing profits[1][4].

Regulatory Environment

Regulatory approvals and compliance play a crucial role in the market dynamics of Adderall XR. The FDA's approval of generic versions and the monitoring of safety and efficacy have been key factors. For instance, the FDA's approval of a generic version by Actavis in 2012 marked a significant shift in the market[5].

Clinical Efficacy and Safety

The clinical efficacy and safety profile of Adderall XR have been well-documented. Studies have shown statistically significant improvements in teacher-rated behavior and performance measures in patients treated with Adderall XR compared to those receiving a placebo. However, the drug also comes with potential side effects, such as increased blood pressure and decreased appetite, which are closely monitored[3].

Future Outlook

The future outlook for Adderall XR and its generic versions is influenced by several factors, including ongoing competition, regulatory changes, and market demand. Shire has historically sought to mitigate the impact of patent expiration through authorized generic versions and strategic partnerships. However, the increasing presence of generic competitors is likely to continue pressuring the market value of the branded drug.

Key Takeaways

• Market Uptake: Adderall XR has been a significant revenue generator for Shire, driven by its strong market uptake in the early 2000s.
• Generic Competition: The entry of generic versions has significantly impacted the financial trajectory of Adderall XR, reducing its market share and revenue.
• Strategic Alliances: Companies like Lannett have formed alliances to distribute generic versions, sharing profits and expanding market reach.
• Regulatory Environment: FDA approvals and regulatory compliance are crucial in shaping the market dynamics of Adderall XR.
• Clinical Efficacy: The drug has a well-documented efficacy profile but also comes with potential side effects that require monitoring.

FAQs

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

Q: Who developed Adderall XR? A: Adderall XR was developed by Shire Plc.

Q: How has the introduction of generic versions affected Adderall XR's market value? A: The introduction of generic versions has led to a significant decline in the market value of the branded drug, with sales of Adderall XR down by 32% in the third quarter of 2012 due to generic competition.

Q: Which companies are involved in distributing generic versions of Adderall XR? A: Companies such as Lannett, Elite Pharmaceuticals, SunGen Pharma, and Impax are involved in distributing generic versions of Adderall XR.

Q: What are some potential side effects of Adderall XR? A: Potential side effects include increased blood pressure, decreased appetite, and exacerbation of motor and phonic tics and Tourette’s syndrome.

Sources

1. Lannett To Commence Marketing Generic Adderall® XR - BioSpace
2. Shire Posts 37% Increase in Pharmaceutical Sales During Q1, But ... - S&P Global
3. 021303Orig1s009 | FDA
4. Lannett Begins Marketing Generic Adderall® XR - BioSpace
5. Shire pays $48m to settle generic Adderall XR claims with Impax - PMLiVE