LISDEXAMFETAMINE DIMESYLATE - Generic Drug Details

What are the generic drug sources for lisdexamfetamine dimesylate and what is the scope of freedom to operate?

Lisdexamfetamine dimesylate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, Hikma, Lannett Co Inc, Mylan, Norwich, Prinston Inc, Rhodes Pharms, Sandoz, Specgx Llc, Sun Pharm Inds Inc, Takeda Pharms Usa, MSN, and Teva Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for LISDEXAMFETAMINE DIMESYLATE

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	20
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	44
Patent Applications:	196
Drug Prices:	Drug price trends for LISDEXAMFETAMINE DIMESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LISDEXAMFETAMINE DIMESYLATE
What excipients (inactive ingredients) are in LISDEXAMFETAMINE DIMESYLATE?	LISDEXAMFETAMINE DIMESYLATE excipients list
DailyMed Link:	LISDEXAMFETAMINE DIMESYLATE at DailyMed

See drug prices for LISDEXAMFETAMINE DIMESYLATE

Recent Clinical Trials for LISDEXAMFETAMINE DIMESYLATE

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

Sponsor	Phase
University of Minnesota	Early Phase 1
Purdue Pharma, Canada	Phase 4
University of Birmingham	N/A

See all LISDEXAMFETAMINE DIMESYLATE clinical trials

Pharmacology for LISDEXAMFETAMINE DIMESYLATE

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

Medical Subject Heading (MeSH) Categories for LISDEXAMFETAMINE DIMESYLATE

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LISDEXAMFETAMINE DIMESYLATE

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LISDEXAMFETAMINE DIMESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYVANSE	Capsules	lisdexamfetamine dimesylate	10 mg	021977	1	2020-04-09
VYVANSE	Capsules	lisdexamfetamine dimesylate	20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg	021977	6	2011-02-23

US Patents and Regulatory Information for LISDEXAMFETAMINE DIMESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	215415-004	Aug 25, 2023	AB	RX	No	No
Amneal	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	202830-001	Aug 25, 2023	AB	RX	No	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-006	Dec 10, 2007	AB	RX	Yes	No

LISDEXAMFETAMINE DIMESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lisdexamfetamine Dimesylate

Introduction

Lisdexamfetamine dimesylate, commonly known by its brand name Vyvanse, is a central nervous system stimulant used primarily to treat Attention Deficit Hyperactivity Disorder (ADHD) and moderate to severe Binge Eating Disorder. The market for this drug has been witnessing significant growth, driven by several key factors.

Market Size and Growth Projections

The lisdexamfetamine dimesylate market is anticipated to experience robust growth over the forecast period. According to market research, the global market for this drug is expected to expand substantially from 2023 to 2031, with projections indicating strong growth rates[1].

Key Drivers of Market Growth

Several factors are driving the growth of the lisdexamfetamine dimesylate market:

Increasing Prevalence of ADHD

The rising prevalence of ADHD, particularly among children and adolescents, is a significant driver. As awareness and diagnosis rates improve, the demand for effective treatments like lisdexamfetamine dimesylate is increasing[4].

FDA Approvals for Generic Versions

Recent FDA approvals for generic versions of Vyvanse by companies such as Elite Pharmaceuticals and Amneal Pharmaceuticals have opened up the market to more competitors. This increased competition is expected to drive down prices and make the medication more accessible, thereby boosting market growth[2][3].

Efficacy and Longer Effectiveness

Lisdexamfetamine dimesylate is known for its longer effectiveness compared to other ADHD medications, which enhances patient compliance and satisfaction. This factor is expected to contribute to the market's expansion, with the drug type sub-segment projected to reach a market value of $5,682.2 million by 2029[4].

Market Segmentation

The market for lisdexamfetamine dimesylate is segmented based on several criteria:

Type

The market is categorized into different purity levels, with 99% purity being a significant segment. Other purity levels also contribute to the overall market size[1].

Application

The primary application is the treatment of ADHD, but the drug is also used for moderate to severe Binge Eating Disorder. This dual application broadens its market reach[1][3].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique market dynamics and growth opportunities[1].

Financial Performance and Sales

The financial performance of lisdexamfetamine dimesylate is impressive, with significant annual sales figures. For the twelve months ending September 2024, the combined brand and generic market for this product recorded annual sales of $4.3 billion[2].

In 2023, U.S. annual sales for lisdexamfetamine dimesylate were reported to be $5.3 billion, highlighting the substantial revenue generated by this medication[3].

Distribution Channels

Retail pharmacies account for the largest share of the market, driven by the increasing number of prescriptions and patient care initiatives by these pharmacies. This distribution channel plays a crucial role in the accessibility and sales of lisdexamfetamine dimesylate[4].

Competitive Landscape

The market for lisdexamfetamine dimesylate is highly competitive, with both brand and generic manufacturers vying for market share. Companies like Elite Pharmaceuticals and Amneal Pharmaceuticals have recently entered the market with FDA-approved generic versions, which is expected to intensify competition and potentially lower prices[2][3].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

Regulatory Hurdles

Stringent regulatory requirements and the risk of product liability claims are significant challenges. Changes in FDA approval requirements and healthcare reforms can also impact the market[3].

Abuse and Dependence

Lisdexamfetamine dimesylate, like other CNS stimulants, has a high potential for abuse and dependence, which is a major concern. This has led to a Boxed Warning in the prescribing information[3].

Economic Factors

The cost of the medication can vary significantly based on factors such as treatment plan, insurance coverage, and the pharmacy used. Economic uncertainties and changes in healthcare policies can also affect market dynamics[5].

Future Outlook

The future outlook for the lisdexamfetamine dimesylate market is promising, with a projected Compound Annual Growth Rate (CAGR) of 15.6% in the forecast period. The increasing demand for effective ADHD treatments, coupled with the entry of generic versions, is expected to drive market expansion[4].

Key Takeaways

• The lisdexamfetamine dimesylate market is expected to experience significant growth from 2023 to 2031.
• FDA approvals for generic versions are increasing market competition and accessibility.
• The drug's longer effectiveness and dual application in ADHD and Binge Eating Disorder are key drivers.
• Retail pharmacies play a major role in the distribution and sales of the medication.
• The market faces challenges such as regulatory hurdles, abuse potential, and economic factors.

FAQs

What is lisdexamfetamine dimesylate used for?

Lisdexamfetamine dimesylate is primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults, as well as moderate to severe Binge Eating Disorder in adults[2][3].

How much does lisdexamfetamine dimesylate cost?

The cost of lisdexamfetamine dimesylate can vary based on factors such as treatment plan, insurance coverage, and the pharmacy used. Generic versions are generally more affordable than brand-name drugs[5].

What are the potential side effects of lisdexamfetamine dimesylate?

Lisdexamfetamine dimesylate, like other CNS stimulants, has a high potential for abuse and dependence. Other side effects can include increased heart rate, blood pressure, and psychiatric symptoms[3].

Which companies have received FDA approval for generic lisdexamfetamine dimesylate?

Companies such as Elite Pharmaceuticals and Amneal Pharmaceuticals have recently received FDA approval for their generic versions of lisdexamfetamine dimesylate[2][3].

What is the projected market value of lisdexamfetamine dimesylate by 2029?

The lisdexamfetamine dimesylate drug type sub-segment is expected to reach a market value of $5,682.2 million by the end of 2029[4].

Sources

1. Market Research Intellect, "Global Lisdexamfetamine Dimesylate Market Size, Trends and Forecasts 2021-2031"
2. Stock Titan, "Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse"
3. Amneal Pharmaceuticals, "Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate"
4. Maximize Market Research, "ADHD Therapeutics Market- Global Industry Analysis And Forecast"
5. Medical News Today, "Lisdexamfetamine cost 2024: Coupons and more"