ADDERALL XR 15 Drug Patent Profile

Which patents cover Adderall Xr 15, and when can generic versions of Adderall Xr 15 launch?

Adderall Xr 15 is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ADDERALL XR 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 XR 15

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 15 at DailyMed

Recent Clinical Trials for ADDERALL XR 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 XR 15 clinical trials

Pharmacology for ADDERALL XR 15

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

US Patents and Regulatory Information for ADDERALL XR 15

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 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	AB1	RX	Yes	No

Expired US Patents for ADDERALL XR 15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002

International Patents for ADDERALL XR 15

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1123087	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
Australia	1214500
Canada	2348090	SYSTEME D'ADMINISTRATION DE MEDICAMENTS PAR DOSES PULSEES PAR VOIE ORALE (ORAL PULSED DOSE DRUG DELIVERY SYSTEM)
Japan	2002527468
Austria	427101
European Patent Office	1977736

ADDERALL XR 15 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Adderall XR

Introduction

Adderall XR, an extended-release formulation of a mixed salt of a single entity amphetamine, is a central nervous system (CNS) stimulant used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. The market dynamics and financial trajectory of Adderall XR are influenced by several factors, including generic competition, regulatory approvals, and the performance of its parent and generic versions.

Market Size and Value

The market for Adderall XR is substantial, with estimated sales values highlighting its significance. As of January 2020, the IQVIA market value for Adderall XR and its generic versions was approximately $1.3 billion for the 12 months ending in that period[1].

Generic Competition

Generic competition has significantly impacted the market dynamics of Adderall XR. The first generic versions of Adderall XR were introduced by companies like Impax Laboratories, with shipments commencing in 2009. These generic versions were available in the same strengths as the brand name product: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules[5].

The entry of multiple generic suppliers, including Lannett Company, Inc., has further fragmented the market. Lannett began marketing its generic version of Adderall XR in 2020, following an agreement with Elite Pharmaceuticals and SunGen Pharma to be the exclusive U.S. distributor[1][4].

Impact on Brand Sales

The introduction of generic versions has led to a decline in sales of the brand-name Adderall XR. For instance, in the fourth quarter of 2012, sales of Adderall XR fell by 35% to $82 million following the launch of Actavis's generic version[2].

Despite this decline, Shire, the original manufacturer, maintained robust total product sales due to strong performances from other ADHD treatments like Vyvanse and Intuniv. However, the company still faced financial implications, including a $48 million payout to Impax to settle legal claims related to the supply of generic Adderall XR[2].

Financial Performance

The financial performance of Adderall XR and its generics is closely tied to the overall market conditions and competition. Here are some key financial indicators:

• Sales Decline: The brand-name Adderall XR experienced a significant sales decline with the introduction of generics. For example, in 2012, the sales dropped by 35% in the fourth quarter[2].
• Generic Market Value: The estimated market value for generic Adderall XR was lower than the brand name, but still substantial, with an IQVIA market value of approximately $1.3 billion for the 12 months ending January 2020[1].
• Revenue Impact: Despite the decline in Adderall XR sales, companies like Shire maintained overall revenue growth due to their diversified product portfolios. Shire's total product sales increased by 5% in the fourth quarter of 2012[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Adderall XR. FDA approvals for generic versions are critical for market entry. For instance, Lannett's strategic alliance partners received FDA approval for their generic Adderall XR, enabling Lannett to commence marketing[4].

Pharmacokinetics and Clinical Studies

The pharmacokinetics of Adderall XR, including its absorption, distribution, metabolism, and excretion, are well-documented. Clinical studies have shown that Adderall XR is effective in treating ADHD, with significant improvements in teacher-rated behavior and performance measures compared to placebo[3].

Side Effects and Safety Considerations

Adderall XR, like other amphetamines, comes with several safety considerations. It can cause hypertension, tics, and decreased appetite. Monitoring of blood pressure and pulse is recommended, especially in patients with hypertension[3].

Market Players

Several companies are involved in the production and distribution of Adderall XR and its generics:

• Shire Plc: The original manufacturer of Adderall XR.
• Impax Laboratories: One of the first companies to introduce a generic version of Adderall XR.
• Lannett Company, Inc.: Entered into an agreement to be the exclusive U.S. distributor of generic Adderall XR.
• Actavis: Launched its own generic version of Adderall XR in 2012[2][5].

Future Outlook

The future outlook for Adderall XR and its generics is influenced by ongoing competition and the potential for new market entrants. Here are some key points:

• Continued Competition: The market is expected to remain competitive with multiple generic suppliers.
• Revenue Stability: Despite competition, the overall market for ADHD treatments is likely to remain robust, supporting revenue stability for companies involved.
• Innovation: Companies may focus on developing new formulations or delivery systems to differentiate their products in a crowded market.

Key Takeaways

• Market Size: The market for Adderall XR and its generics is substantial, with an estimated value of $1.3 billion.
• Generic Competition: Multiple generic versions have significantly impacted brand-name sales.
• Financial Performance: Brand-name sales have declined, but overall revenue for companies with diversified portfolios remains robust.
• Regulatory Environment: FDA approvals are crucial for market entry of generic versions.
• Safety Considerations: Monitoring of side effects such as hypertension and tics is necessary.

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 are the key players in the Adderall XR market? A: Key players include Shire Plc, Impax Laboratories, Lannett Company, Inc., and Actavis.

Q: How has generic competition affected Adderall XR sales? A: Generic competition has led to a significant decline in brand-name Adderall XR sales, with a 35% drop in the fourth quarter of 2012.

Q: What are the common side effects of Adderall XR? A: Common side effects include hypertension, tics, and decreased appetite.

Q: What is the estimated market value of Adderall XR and its generics? A: The estimated IQVIA market value for Adderall XR and its generics was approximately $1.3 billion for the 12 months ending January 2020.

Sources

1. Lannett Begins Marketing Generic Adderall® XR - BioSpace
2. Shire weathers generic Adderall XR challenge - PMLiVE
3. FDA Approval Document for Adderall XR - FDA
4. Lannett To Commence Marketing Generic Adderall® XR - BioSpace
5. Impax Laboratories Commences Shipment of Generic Adderall XR - Impax Laboratories