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 three branded drugs marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, Elite Labs Inc, Granules, Hikma, Lannett Co Inc, Mylan, Norwich, Prinston Inc, Rhodes Pharms, Sandoz, Specgx Llc, Sun Pharm Inds Inc, Takeda Pharms Usa, Azurity, MSN, and Teva Pharms, and is included in twenty-five NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lisdexamfetamine dimesylate has seventeen patent family members in sixteen countries.

Twenty suppliers are listed for this compound.

Summary for LISDEXAMFETAMINE DIMESYLATE

International Patents:	17
US Patents:	2
Tradenames:	3
Applicants:	20
NDAs:	25
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	46
Patent Applications:	463
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
Johns Hopkins University	PHASE2
Eli Lilly and Company	PHASE2
Humanis Saglk Anonim Sirketi	PHASE1

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
Lannett Co Inc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	215802-007	Aug 25, 2023	AB	RX	No	No
Lannett Co Inc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	215802-004	Aug 25, 2023	AB	RX	No	No
Teva Pharms	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	215415-006	Aug 25, 2023	AB	RX	No	No
Ascent Pharms Inc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	217068-001	Aug 25, 2023	AB	RX	No	No

International Patents for LISDEXAMFETAMINE DIMESYLATE

Country	Patent Number	Title	Estimated Expiration
Israel	294249	תמיסות למתן דרך הפה המכילות מלחי ליזדקסאמפטאמין (Oral solutions comprising lisdexamfetamine salts)
Lithuania	3845215
Croatia	P20221241
Australia	2020416052	Oral solutions comprising lisdexamfetamine salts

Supplementary Protection Certificates for LISDEXAMFETAMINE DIMESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	122013000079	Germany		PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201
1644019	SPC/GB13/052	United Kingdom		PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
1644019	LUC00189	Luxembourg		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901
1644019	2020C/543	Belgium		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONEEL IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDE-ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE562026, BE562035, BE562044, BE562053, BE562062, BE562071 20200520

Market Dynamics and Financial Trajectory for Lisdexamfetamine Dimesylate

Last updated: October 26, 2025

Introduction
Lisdexamfetamine dimesylate (commonly marketed as Vyvanse) stands as a prominent stimulant medication primarily used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and moderate to severe binge eating disorder. Its unique pharmacological profile, combined with evolving regulatory guidelines and market trends, significantly influences its market dynamics and financial trajectory. Understanding these factors offers critical insights for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers.

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Pharmacological Profile and Market Position
Lisdexamfetamine dimesylate is a prodrug of dextroamphetamine. Its design facilitates a gradual release of active drug, resulting in a prolonged therapeutic effect and reduced abuse potential compared to traditional stimulants like adderall. This safety profile positions LisDexamfetamine favorably within the ADHD treatment landscape, especially amid rising concerns over stimulant misuse.

According to the FDA approval in 2007, LisDexamfetamine secured a unique niche due to its lower abuse potential, serving as a key differentiator in a competitive stimulant market. The drug’s mechanism—delayed conversion into dextroamphetamine—supports its preferred status for patients requiring sustained symptom control.

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Market Dynamics Influencing Lisdexamfetamine Dimesylate

1. Market Demand Drivers

The global ADHD therapeutics market is projected to witness compounded annual growth rates (CAGRs) of approximately 6-8% from 2022 through 2030, driven by increasing diagnosis rates, expanding age groups treated, and heightened awareness. The American Psychiatric Association's latest guidelines recommend stimulant medications as first-line therapy, with LisDexamfetamine positioned as a durable and abuse-mitigating option.

Binge eating disorder, an off-label but increasingly recognized indication, broadens the drug’s application scope. The FDA’s approval for this indication in 2015 further expands the therapeutic market, potentially doubling revenue streams.

2. Regulatory Landscape

Regulatory authorities globally have tightened oversight over stimulant medications, focusing on abuse deterrence. LisDexamfetamine benefits from the Abuse-Deterrent Formulation (ADF) design, which acts as a competitive advantage. Additionally, certain markets are exploring scheduling adjustments to mitigate misuse risks, influencing market access and pharmacy stocking.

3. Manufacturing and Supply Chain Considerations

The complex synthesis and formulation process of LisDexamfetamine entails significant manufacturing costs. Supply chain disruptions—whether due to geopolitical tensions, raw material shortages, or pandemic-related disturbances—impact production volumes and, ultimately, sales. Strategic manufacturing partnerships and inventory management are thus vital to maintaining consistent supply.

4. Competitive Landscape

The market faces ongoing competition from non-stimulant medications like atomoxetine, as well as other stimulants such as methylphenidate derivatives and generic formulations. The entry of generic lisdexamfetamine post-patent expiry has substantially eroded the drug’s premium pricing, affecting revenue growth margins. However, branded formulations retain patient and prescriber loyalty due to consistent efficacy and abuse-deterrent features.

5. Pricing and Reimbursement Dynamics

Pricing strategies hinge on market penetration, formulary access, and insurance reimbursement policies. In the U.S., insurers’ shift toward preferred stimulant therapies influences prescribing patterns. The high cost of branded LisDexamfetamine incentivizes utilization of generics, heightening price sensitivity. Conversely, in emerging markets, affordability and healthcare infrastructure impact pricing and access.

6. Prescriber and Patient Acceptance

A paradigm shift favoring long-acting formulations underscores LisDexamfetamine's convenience and compliance advantages. Patient preference for once-daily dosing enhances demand, especially within school-aged populations and working adults. Nevertheless, concerns about stimulant side effects and misuse potential remain barriers, necessitating ongoing educational and safety initiatives.

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Financial Trajectory and Revenue Outlook

Current Revenue Landscape
Global sales of LisDexamfetamine peaked at approximately $1.1 billion in 2021, with North America representing the majority of revenue—reflecting high diagnosis rates and reimbursement coverage. The drug’s market share has faced downward pressure from patent expirations and increased generic competition but remains substantial due to brand loyalty and ongoing indications.

Growth Forecasts
Analysts project a tempered growth of 4-5% CAGR in North American markets over the next five years, driven by expanding adult ADHD diagnoses and off-label uses. In emerging markets, rapid healthcare infrastructure development and evolving prescribing protocols could propel higher double-digit growth rates. The expansion into binge eating disorder treatment assets is expected to contribute an additional 10-15% revenue uplift over the next decade.

Impact of Patent and Generic Competition
Generic extensions post-2017 have markedly reduced LisDexamfetamine’s per-unit pricing, compressing profit margins yet increasing volume sales. Proprietary abuse-deterrent formulations and potential new indications serve as strategic tools for sustaining exclusive revenue streams.

Potential Market Challenges and Opportunities
Regulatory hurdles, shifting clinical guidelines, and societal scrutiny over stimulant abuse create headwinds. Conversely, technological innovations in drug delivery, personalized medicine, and digital health integration (e.g., adherence monitoring devices) offer avenues to enhance market penetration and optimize financial returns.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on lifecycle management through new formulations, expanded indications, and targeted marketing. Emphasize abuse-resistant features to maintain competitive edge amidst regulatory scrutiny.
• Investors: Monitor patent statuses, approval pipelines for related compounds, and evolving insurer reimbursement policies. Diversify portfolios considering the impact of generics and biosimilars.
• Healthcare Providers: Balance efficacy, safety, and abuse potential when prescribing. Stay informed about regulatory changes affecting prescribing patterns and coverage.
• Policy Makers: Support regulations that incentivize safe prescribing practices while facilitating access to effective therapies, especially in underserved markets.

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Key Takeaways

• Lisdexamfetamine dimesylate remains a pivotal stimulant medication, with a growing footprint in ADHD and binge eating disorder markets due to its safety profile and long-acting delivery.
• Market dynamics are heavily influenced by regulatory shifts, patent expirations, and increased competition from generics and alternative therapies.
• The financial outlook indicates moderate growth, with strong potential in emerging markets and expanded indications, provided manufacturing, pricing, and regulatory challenges are managed effectively.
• Strategic innovations such as abuse-deterrent formulations and digital health integrations are crucial for sustaining revenue streams amidst a complex competitive landscape.
• Stakeholders must navigate evolving prescribing trends, reimbursement policies, and societal attitudes while leveraging emerging opportunities to optimize market share and profitability.

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FAQs

1. When does the patent for Lisdexamfetamine Dimesylate expire, and how does it impact the market?
Patent expiration typically occurred in the U.S. in 2023, paving the way for generic formulations that challenge the branded drug's market share and profit margins. This increased price competition necessitates strategic innovations and expanded indications to sustain revenue.

2. What are the primary clinical advantages of Lisdexamfetamine over other stimulants?
Its prodrug design confers a lower abuse potential, prolonged duration of action, and consistent plasma levels, leading to improved adherence and safety profiles. This positions it favorably among clinicians prioritizing abuse deterrence.

3. How does regulatory environment influence the financial trajectory of LisDexamfetamine?
Stringent regulations focusing on abuse prevention and scheduling can restrict access and prescribing, impacting sales. Conversely, approvals for additional indications expand the market, positively influencing revenue.

4. What emerging markets present growth opportunities for Lisdexamfetamine?
Markets in Asia-Pacific, Latin America, and the Middle East exhibit increasing ADHD diagnoses, rising healthcare infrastructure, and expanding insurance coverage, making them attractive for future growth.

5. How might digital health innovations impact the market for Lisdexamfetamine?
Digital adherence tools and remote monitoring can enhance treatment compliance, reduce misuse, and support personalized dosing, bolstering the drug’s market attractiveness and healthcare outcomes.

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References
[1] FDA approval documents for Vyvanse (Lisdexamfetamine Dimesylate), 2007.
[2] Market research reports on ADHD therapeutics, 2022-2023.
[3] Industry analyses on patent expiry and generic competition, 2023.
[4] Regulatory guidelines on stimulant abuse deterrence, 2022.
[5] Clinical studies on expanded indications and digital health integration, 2021-2022.