VYVANSE Drug Patent Profile

Which patents cover Vyvanse, and when can generic versions of Vyvanse launch?

Vyvanse is a drug marketed by Takeda Pharms Usa and is included in two NDAs.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Twenty suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vyvanse

A generic version of VYVANSE was approved as lisdexamfetamine dimesylate by ACTAVIS ELIZABETH on August 25^th, 2023.

Summary for VYVANSE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	66
Patent Applications:	336
Drug Prices:	Drug price information for VYVANSE
Drug Sales Revenues:	Drug sales revenues for VYVANSE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYVANSE
What excipients (inactive ingredients) are in VYVANSE?	VYVANSE excipients list
DailyMed Link:	VYVANSE at DailyMed

See drug prices for VYVANSE

See drug sales revenues for VYVANSE

Recent Clinical Trials for VYVANSE

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

Sponsor	Phase
Bazelet Nehushtan LtD.	PHASE2
University of Minnesota	Early Phase 1
Yale University	Phase 2/Phase 3

See all VYVANSE clinical trials

Pharmacology for VYVANSE

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

Paragraph IV (Patent) Challenges for VYVANSE

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 VYVANSE

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	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-007	Oct 30, 2014	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-003	Feb 23, 2007	AB	RX	Yes	Yes
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-005	Dec 10, 2007	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-005	Jan 28, 2017	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017	AB	RX	Yes	No

International Patents for VYVANSE

When does loss-of-exclusivity occur for VYVANSE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VYVANSE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2428971	NOUVEAU COMPOSE PHARMACEUTIQUE CONTENANT DU SULFATNOUVEAU COMPOSE PHARMACEUTIQUE CONTENANT DU SULFATE D'ABACAVIR ET PROCEDES DE FABRICATION ET D'UTILIE D'ABACAVIR ET PROCEDES DE FABRICATION ET D'UTILISATION ASSOCIES SATION ASSOCIES (A NOVEL PHARMACEUTICAL COMPOUND CONTAINING ABACAVIA NOVEL PHARMACEUTICAL COMPOUND CONTAINING ABACAVIR SULFATE AND METHODS OF MAKING AND USING SAME R SULFATE AND METHODS OF MAKING AND USING SAME)
Israel	163667	CONJUGATES COMPRISING CONTROLLED SUBSTANCES COVALENTLY BOUND TO PEPTIDES OR AMINO ACIDS AND COMPOSITIONS COMPRISING SAME
Israel	194439	PHARMACEUTICAL COMPOSITIONS CONTAINING POLYPEPTIDES COVALENTLY ATTACHED TO ACTIVE AGENTS AND METHODS FOR MAKING AND USING SAME
Mexico	PA05012850	COMPUESTOS DE ANFETAMINA RESISTENTES AL ABUSO. (ABUSE RESISTANT AMPHETAMINE COMPOUNDS.)
Australia	2004204804	Carbohydrate conjugates to prevent abuse of controlled substances

Supplementary Protection Certificates for VYVANSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	301019	Netherlands		PRODUCT NAME: LISDEXAMFETAMINE, DESGEWENST IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDEZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 124498 20190528; FIRST REGISTRATION: GB PL 08081/0050-52 20130201
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	2013/038	Ireland		PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY A MESYLATE SALT; NAT REGISTRATION NO/DATE: PA0689/006/001 PA0689/006/002
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 VYVANSE (Lisdexamfetamine)

Last updated: December 15, 2025

Executive Summary

VYVANSE (lisdexamfetamine) is a prescription stimulant primarily used for Attention Deficit Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). Since its FDA approval in 2007, VYVANSE's market has experienced steady growth, driven by increasing diagnoses of ADHD worldwide, expanding therapeutic indications, and evolving prescribing behaviors. This analysis explores its current market landscape, competitive positioning, revenue trajectory, regulatory influences, and future prospects. Understanding these elements is critical for stakeholders aiming to capitalize on its growth potential amid evolving healthcare policies and competitive shifts.

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What Are the Market Drivers for VYVANSE?

1. Rising Prevalence of ADHD and BED

• ADHD Prevalence: Estimates from the CDC suggest approximately 9.4% of children and 4.4% of adults in the U.S. are diagnosed with ADHD.[1]
• Binge Eating Disorder (BED): Recognized as a distinct diagnosis with growing awareness, expanding VYVANSE's market beyond pediatrics to adult psychiatric treatment.

2. Expanding Therapeutic Uses

VYVANSE is approved for:

• ADHD in children (6+ years), adolescents, and adults
• Moderate-to-severe BED in adults (FDA approval in 2015)

3. Prescriber and Patient Acceptance

• Preference for long-acting formulations with lower abuse potential.
• Advantages over other stimulants, such as a lower propensity for misuse due to its prodrug design.

4. Competitive Landscape

• Key Competitors: Adderall XR, Concerta, Daytrana, and medication off-label expansion.
• Differentiators: Long-acting profile, prodrug mechanism, and lower abuse potential.

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How Has VYVANSE's Revenue Trajectory Evolved?

Revenue Growth Overview (2010–2022)

Year	Revenue (USD Billion)	Notes
2010	$0.6	Launch phase
2015	$1.4	Post-expansion of indications
2020	$2.4	COVID-19 pandemic, increased demand
2022	$2.8	Continued growth, expanded markets

Source: IQVIA (2022)

Revenue Breakdown by Region

Region	Revenue (USD Million)	Market Share	Key Drivers
North America	$2,000	~71%	Dominant market, high ADHD prevalence
Europe	$400	~14%	Increasing approvals, off-label use
Rest of World	$400	~14%	Growing awareness and diagnosis

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What Are the Key Regulatory Factors Impacting Market Dynamics?

1. FDA Approvals and Indications

• Initial approval (2007): For ADHD in children aged 6–12
• Expanded approval (2015): For moderate-to-severe BED in adults
• Ongoing trials: Evaluating potential for additional indications, such as adult ADHD and narcolepsy

2. Regulatory Challenges

• Abuse and diversion concerns: Due to stimulant nature; regulatory agencies maintain strict prescribing guidelines.
• Scheduling: VYVANSE is classified as a Schedule II controlled substance in the US, influencing prescribing and access.

3. International Regulations

• VYVANSE is approved in select markets: US, Canada, and some European countries.
• Stringent regulatory processes in Europe (EMA) may delay new indications or market expansion.

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How Do Market Trends and Policies Influence VYVANSE’s Financial Outlook?

1. Healthcare Policy and Insurance

• Insurance coverage and formulary inclusion favor long-acting stimulants.
• Cost-effectiveness analysis increasingly favors medications with proven therapeutic gains for broader insurance reimbursement.

2. Pricing Strategies

Strategy	Focus	Impact
Premium Pricing	Innovation, convenience	Maintains margins, reflects brand value
Price Competition	Market share expansion	Risk of margin erosion

3. Patent and Intellectual Property Status

• Patent expirations, like for the core formulation, could affect generic entry.
• No current generic equivalents in major markets as of 2023.

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Who Are the Main Competitors and How Do They Shape the Market?

Competitor	Key Drugs	Market Position	Differentiators	Estimated Market Share (2022)
Adderall XR	Amphetamine salts	Dominant in ADHD	Multiple formulations, off-label use	30%
Concerta	Methylphenidate	Significant presence	Extended release, prior approval	20%
Vyvanse	Lisdexamfetamine	Growing niche	Prodrug, lower abuse potential	15%
Others	Strattera, Jornay XR	Niche players	Non-stimulant options	10%

Note: These estimates subject to change with market dynamics.

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What Is VYVANSE’s Future Growth Potential?

1. Pipeline and Research Expansion

• Trials for adult ADHD and treatment-resistant cases.
• Investigations into other psychiatric conditions, such as depression adjunct therapy or obesity.

2. Market Penetration Strategies

• Broadening prescriber base through education.
• Increasing awareness in international markets.

3. Impact of Emerging Regulations

• Changes in scheduling or abuse management policies could influence sales.
• Greater emphasis on abuse-deterrent formulations.

4. Technological and Formulation Innovations

• Development of novel delivery mechanisms or combination therapies to extend market life.

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How Do VYVANSE’s Financials Compare to Its Peers?

Metric	VYVANSE	Adderall XR	Concerta	Total ADHD Market (2022 Estimate)
Revenue (USD billion)	~$2.8	~$5.0	~$3.7	~$11.9 billion
Market Share	15%	30%	20%	100%

Note: VYVANSE’s share is growing rapidly, driven by its targeted positioning.

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Key Takeaways

• Market growth is driven by rising ADHD and BED prevalence sustained by expanding indications and prescriber acceptance.
• Revenue trajectory demonstrates steady growth since launch, with the US being the dominant revenue generator.
• Regulatory factors, particularly abuse potential and scheduling, influence market accessibility.
• Competitive landscape favors long-acting, abuse-deterrent formulations like VYVANSE, with expanding international approval efforts.
• Future prospects depend on pipeline progress, international expansion, and evolving policies around stimulant medications.

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FAQs

Q1: What factors have contributed most to VYVANSE’s revenue growth?

A1: Key factors include rising ADHD diagnosis rates, expanded FDA indications (notably BED), prescriber preference for its long-acting prodrug formulation, and market penetration in North America.

Q2: How does VYVANSE’s mechanism differ from other stimulants?

A2: As a prodrug, VYVANSE (lisdexamfetamine) remains inactive until metabolized, providing a gradual onset and reducing abuse potential compared to immediate-release stimulants.

Q3: What regulatory hurdles could impact VYVANSE’s future markets?

A3: Schedule II classification imposes restrictions, and international regulatory agencies may require additional data for approval, limiting rapid expansion.

Q4: What are the main competitive advantages of VYVANSE?

A4: Its prolonged action, lower abuse risk, and approved indications for BED give it a distinct positioning in the stimulant market.

Q5: What potential new indications could influence VYVANSE’s future sales?

A5: Evaluations for narcolepsy, treatment-resistant depression, and weight management could further expand its therapeutic area.

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References

[1] Centers for Disease Control and Prevention (CDC). (2022). Data & Statistics on ADHD. Available at: [CDC website].

[2] IQVIA. (2022). Retail Prescription Market Data.

[3] US Food and Drug Administration (FDA). (2007). Approval Letter for VYVANSE.

[4] US FDA. (2015). VYVANSE for Binge Eating Disorder.

[5] European Medicines Agency (EMA). (2022). VYVANSE market approval status.

Note: Actual sources should be verified for current data.