ADDERALL XR 10 Drug Patent Profile

When do Adderall Xr 10 patents expire, and what generic alternatives are available?

Adderall Xr 10 is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ADDERALL XR 10 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-nine 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 10

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
Patent Applications:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADDERALL XR 10
DailyMed Link:	ADDERALL XR 10 at DailyMed

Recent Clinical Trials for ADDERALL XR 10

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 10 clinical trials

Pharmacology for ADDERALL XR 10

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

US Patents and Regulatory Information for ADDERALL XR 10

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 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-001	Oct 11, 2001	AB1	RX	Yes	No

Expired US Patents for ADDERALL XR 10

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ADDERALL XR 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-001	Oct 11, 2001
Takeda Pharms Usa	ADDERALL XR 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-001	Oct 11, 2001
Takeda Pharms Usa	ADDERALL XR 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-001	Oct 11, 2001
Takeda Pharms Usa	ADDERALL XR 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-001	Oct 11, 2001

International Patents for ADDERALL XR 10

See the table below for patents covering ADDERALL XR 10 around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2348090	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
Austria	427101
European Patent Office	1123087	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
Germany	69940673
Japan	2002527468
Japan	2008303223	ORAL PULSED DOSE DRUG DELIVERY SYSTEM

Market Dynamics and Financial Trajectory of Adderall XR 10mg

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. The market dynamics and financial trajectory of Adderall XR 10mg are influenced by several factors, including supply and demand, competition, regulatory environments, and pricing strategies.

Historical Context and Supply Chain Issues

Early Shortages and Price Increases

In the past, Adderall XR has faced several shortages, which have significantly impacted its market dynamics. For instance, in 2010, a shortage led to Shire, the manufacturer, increasing the price and reducing discounts, resulting in higher costs for consumers and increased sales for the company despite the shortage[2].

Recent Shortages and Price Hikes

The most recent shortage, reported by the FDA in October 2022, has led to a substantial increase in prices for ADHD medications, including Adderall XR. The prices of certain ADHD medications have nearly doubled or tripled since the shortage began, affecting patients and caregivers significantly[1].

Pricing and Cost Implications

Current Pricing Trends

The cost of Adderall XR has seen dramatic fluctuations. For example, the price of a 30-day supply of Adderall XR 10mg can range from $5 to $158, depending on the pharmacy and insurance coverage. In contrast, Vyvanse, another ADHD medication, can cost around $165 for a 30-day supply[1].

Impact on Consumers

The price increases have been particularly challenging for families without adequate insurance coverage. Consumers have reported significant financial strain, with some families facing monthly costs that have increased from $10 to $158 for the same medication[1].

Competition and Generic Versions

Generic Market Entry

The introduction of generic versions of Adderall XR has been a significant factor in the market dynamics. Companies like Lannett have begun marketing generic Adderall XR, offering more affordable alternatives to patients. Lannett's generic version, launched in March 2020, includes various strengths and is expected to reduce the overall cost for patients[4].

Legal and Contractual Disputes

Shire has faced legal battles with companies like Impax over the supply of authorised generic versions of Adderall XR. These disputes have led to settlements and updated distribution agreements, affecting the revenue share and market presence of these generic versions[5].

Regulatory Environment

DEA Regulations

Adderall XR, being a controlled substance, is subject to DEA regulations that limit its production. Shire has cited these regulations as a reason for the shortages, although other companies have disputed this, suggesting that Shire's production quota agreements may be the actual cause[2].

FDA Approvals

The FDA's approval of generic versions, such as those from Watson subsidiary Actavis, has further impacted Shire's financial performance. These approvals have led to increased competition and reduced sales for the branded version of Adderall XR[5].

Financial Performance

Revenue Impact

Despite the challenges posed by shortages and generic competition, Adderall XR has remained a significant revenue generator for Shire. In 2011, Adderall XR achieved revenues of $532 million, making it one of Shire's biggest earners. However, the introduction of generic versions has led to a decline in sales, with a 32% drop in the third quarter of 2012 following FDA approval for a generic version[5].

Sales Strategies

Shire's response to shortages has included price increases and reduced discounts, which have paradoxically led to increased sales. This strategy has been criticized for potentially manipulating the supply to maintain higher prices and profits[2].

Consumer and Market Response

Patient Struggles

Patients and caregivers have faced significant challenges in obtaining the medication due to shortages and price increases. This has led to creative solutions, such as using manufacturer coupons and finding alternative pharmacies to reduce costs[1].

Market Perception

The perception of the market is that the shortages and price increases are often driven by corporate strategies rather than genuine supply issues. This has led to public and legal scrutiny of pharmaceutical companies like Shire[2].

Future Outlook

Generic Competition

The continued entry of generic versions is expected to increase competition and potentially reduce prices. However, the market value of generic Adderall XR is expected to be lower than the branded version, indicating that while prices may decrease, they may not drop significantly[4].

Regulatory Changes

Any changes in DEA regulations or FDA policies could impact the production and distribution of Adderall XR, potentially alleviating shortages and stabilizing prices.

Key Takeaways

• Supply Chain Issues: Recent shortages have significantly increased the prices of ADHD medications, including Adderall XR.
• Pricing Trends: Prices for Adderall XR have fluctuated widely, affecting consumers differently based on insurance coverage.
• Generic Competition: The introduction of generic versions has provided more affordable alternatives but has also led to legal disputes over supply agreements.
• Regulatory Impact: DEA regulations and FDA approvals play crucial roles in the production and distribution of Adderall XR.
• Financial Performance: Despite challenges, Adderall XR remains a significant revenue generator, though sales have declined with the introduction of generics.

FAQs

Q: What is the current price range for a 30-day supply of Adderall XR 10mg?

A: The price can range from $5 to $158, depending on the pharmacy and insurance coverage[1].

Q: Why have the prices of ADHD medications, including Adderall XR, increased recently?

A: The prices have increased due to a shortage reported in October 2022, which has led to higher costs for patients[1].

Q: Are there generic versions of Adderall XR available?

A: Yes, companies like Lannett have launched generic versions of Adderall XR, offering more affordable alternatives[4].

Q: How do DEA regulations affect the production of Adderall XR?

A: DEA regulations limit the production of Adderall XR as it is a controlled substance, which can contribute to shortages[2].

Q: What is the impact of FDA approvals on the market for Adderall XR?

A: FDA approvals for generic versions have increased competition, leading to reduced sales for the branded version of Adderall XR[5].

Sources

1. ADHD Medication Costs Soar: Price Report - ADDitude
2. Faced With a "Shortage" of Adderall, Maker Jacks Up the Price - CBS News
3. Adderall - Wikipedia
4. Lannett Begins Marketing Generic Adderall® XR - BioSpace
5. Shire pays $48m to settle generic Adderall XR claims with Impax - PMLive

Last updated: 2024-12-17