ADDERALL XR 25 Drug Patent Profile

Which patents cover Adderall Xr 25, and when can generic versions of Adderall Xr 25 launch?

Adderall Xr 25 is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ADDERALL XR 25 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 25

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 25 at DailyMed

Recent Clinical Trials for ADDERALL XR 25

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 25 clinical trials

Pharmacology for ADDERALL XR 25

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

US Patents and Regulatory Information for ADDERALL XR 25

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 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	AB1	RX	Yes	No

Expired US Patents for ADDERALL XR 25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ADDERALL XR 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	6,322,819*PED
Takeda Pharms Usa	ADDERALL XR 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	RE42096*PED
Takeda Pharms Usa	ADDERALL XR 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	RE41148*PED
Takeda Pharms Usa	ADDERALL XR 25	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-004	May 22, 2002	6,605,300*PED

International Patents for ADDERALL XR 25

See the table below for patents covering ADDERALL XR 25 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 25 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adderall XR

Introduction to Adderall XR

Adderall XR is an extended-release mixed salt of a single entity amphetamine product, indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. It is a central nervous system (CNS) stimulant, available in various strengths including 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules or tablets[3][4].

Market Size and Value

The market for Adderall XR, including its generic versions, is substantial. As of 2020, the estimated IQVIA market value for Adderall XR and its generics was approximately $1.3 billion for the 12 months ending January 2020. However, actual generic market values are expected to be lower due to competition from multiple generic suppliers[4].

Competitive Landscape

The market for Adderall XR is highly competitive, with several generic versions available. Companies like Lannett, Impax Laboratories, and others have entered the market with their generic versions. Lannett, for example, commenced marketing its generic version of Adderall XR in March 2020, following an agreement with Elite Pharmaceuticals and SunGen Pharma[1][4].

Financial Performance of Key Players

Lannett Company, Inc.

Lannett has seen significant activity in the generic pharmaceutical market, including the launch of its generic Adderall XR. The company's financial performance has been influenced by the sales of this product. In 2019, Lannett announced its plan to market the generic version, which was expected to contribute to its revenue growth. The company has also launched other products, further diversifying its revenue streams[1][4].

Impax Laboratories, Inc.

Impax Laboratories reported substantial growth in revenue and profit in the third quarter of 2010, largely driven by the sales of generic Adderall XR. The company's adjusted net revenue increased by $42.6 million, and its net income rose to $15.8 million, or $0.24 per diluted share, compared to the prior year period. This growth was also attributed to increased sales of other products like fenofibrate[2].

Revenue and Profit Margins

The revenue generated from Adderall XR and its generics has been significant for pharmaceutical companies. For instance, Impax Laboratories saw a notable increase in revenue due to the sales of generic Adderall XR. The company's gross profit margin, however, slightly declined from 59% to 57% in the third quarter of 2010 due to a higher concentration of lower-margin products[2].

Research and Development Expenses

The development and marketing of generic Adderall XR involve considerable research and development expenses. Impax Laboratories, for example, increased its R&D spending by $3.9 million in the third quarter of 2010, primarily due to higher spending on bioequivalency studies, active pharmaceutical ingredients, and compensation expenses[2].

Marketing and Distribution

Companies like Lannett play a crucial role in the marketing and distribution of generic Adderall XR. Lannett's agreement with Elite Pharmaceuticals and SunGen Pharma allows it to provide sales, marketing, and distribution support for the product, earning a share of the profits in return[1][4].

Clinical Efficacy and Safety

Adderall XR has demonstrated significant clinical efficacy in treating ADHD. Studies have shown that patients receiving fixed doses of Adderall XR experienced statistically significant improvements in teacher-rated behavior and performance measures compared to those treated with placebo. However, the drug also comes with potential side effects, such as increased blood pressure, decreased appetite, and the risk of exacerbating tics and Tourette’s syndrome[3].

Regulatory Environment

The FDA approval process is critical for the launch of any pharmaceutical product, including generic versions of Adderall XR. Companies must adhere to strict regulatory guidelines and conduct thorough clinical trials to ensure the safety and efficacy of their products. Lannett's generic Adderall XR, for instance, received FDA approval through its strategic alliance partners[1][4].

Future Outlook

The market for Adderall XR and its generics is expected to remain competitive. With multiple generic suppliers, the prices of these products are likely to remain under pressure. However, the demand for ADHD treatments continues to grow, ensuring a stable market for these medications. Companies like Lannett are poised to benefit from this demand as they continue to expand their product portfolios and improve their distribution networks[4].

Key Takeaways

• Market Size: The estimated market value for Adderall XR and its generics is approximately $1.3 billion.
• Competitive Landscape: Multiple generic suppliers, including Lannett and Impax Laboratories, are active in the market.
• Financial Performance: Significant revenue growth has been reported by companies due to the sales of generic Adderall XR.
• Clinical Efficacy: Adderall XR has shown substantial clinical efficacy in treating ADHD.
• Regulatory Environment: FDA approval is crucial for the launch of generic versions.
• Future Outlook: The market is expected to remain competitive with stable demand for ADHD treatments.

Frequently Asked Questions (FAQs)

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

2. Who are the key players in the generic Adderall XR market? Key players include Lannett Company, Inc., Impax Laboratories, Inc., and other pharmaceutical companies that have received FDA approval for their generic versions.

3. What are the potential side effects of Adderall XR? Potential side effects include increased blood pressure, decreased appetite, and the risk of exacerbating tics and Tourette’s syndrome.

4. How much is the estimated market value for Adderall XR and its generics? The estimated market value is approximately $1.3 billion for the 12 months ending January 2020.

5. What role does Lannett Company, Inc. play in the marketing of generic Adderall XR? Lannett provides sales, marketing, and distribution support for the product through its agreement with Elite Pharmaceuticals and SunGen Pharma, earning a share of the profits in return.

Sources:

1. Lannett To Commence Marketing Generic Adderall® XR - BioSpace
2. Impax Laboratories Reports Growth in Revenue, Profit and Earnings - Business Wire
3. Adderall XR (amphetamine product) - FDA
4. Lannett Begins Marketing Generic Adderall® XR - BioSpace