INTUNIV Drug Patent Profile

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

Intuniv is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in INTUNIV is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intuniv

A generic version of INTUNIV was approved as guanfacine hydrochloride by WATSON LABS on October 17^th, 1995.

Summary for INTUNIV

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	29
Patent Applications:	1,374
Drug Prices:	Drug price information for INTUNIV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTUNIV
What excipients (inactive ingredients) are in INTUNIV?	INTUNIV excipients list
DailyMed Link:	INTUNIV at DailyMed

See drug prices for INTUNIV

See drug sales revenues for INTUNIV

Recent Clinical Trials for INTUNIV

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

Sponsor	Phase
Maimonides Medical Center	Phase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
Takeda Development Center Americas, Inc.	Phase 4

See all INTUNIV clinical trials

Pharmacology for INTUNIV

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Paragraph IV (Patent) Challenges for INTUNIV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTUNIV	Extended-release Tablets	guanfacine hydrochloride	1 mg, 2 mg, 3 mg and 4 mg	022037	1	2009-12-29

US Patents and Regulatory Information for INTUNIV

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	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	AB	RX	Yes	No
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	AB	RX	Yes	Yes
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	AB	RX	Yes	No
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	AB	RX	Yes	No

Expired US Patents for INTUNIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009

International Patents for INTUNIV

See the table below for patents covering INTUNIV around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1351668
European Patent Office	1351668	FORMES DE DOSAGE PHARMACEUTIQUE A LIBERATION PROLONGEE POSSEDANT DES PROFILES DE DISSOLUTION A DEPENDANCE AU PH REDUITE AU MINIMUM (SUSTAINED RELEASE PHARMACEUTICAL DOSAGE FORMS WITH MINIMIZED PH DEPENDENT DISSOLUTION PROFILES)
World Intellectual Property Organization (WIPO)	9816226
Australia	6281298
Japan	2004518676
Japan	4340840

Market Dynamics and Financial Trajectory for INTUNIV: A Comprehensive Analysis

Last updated: December 16, 2025

Summary

INTUNIV (guanfacine extended-release), developed and marketed by Takeda Pharmaceuticals, is a prominent prescription medication primarily indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. This report provides a detailed overview of the current market landscape, key drivers, competitive positioning, regulatory considerations, and financial trajectory forecasts for INTUNIV. Our analysis synthesizes recent sales data, patent protections, patent cliffs, manufacturing trends, and pricing policies, alongside macroeconomic factors influencing its commercial success.

Introduction

INTUNIV is a once-daily extended-release formulation of guanfacine, an alpha-2 adrenergic receptor agonist. Approved by the U.S. Food and Drug Administration (FDA) in 2010, it has secured a solid foothold in the pediatric ADHD market, where it competes with stimulant therapies (e.g., methylphenidate, amphetamines), as well as other non-stimulant options such as clonidine and newer agents like viloxazine.

Understanding INTUNIV’s market trajectory involves analyzing its clinical positioning, patent lifecycle, generics entry, macroeconomic environment, and evolving treatment guidelines.

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Market Overview and Size

Parameter	Details
Global ADHD drug market size (2022)	Estimated at USD 12.5 billion [1]
U.S. ADHD drug market share (2022)	Approx. USD 8 billion
INTUNIV's market share (2022)	~USD 750 million (estimated)
Key competitors	STIMULANTS: Concerta, Vyvanse, Adderall; NON-STIMULANTS: Clonidine, XR formulations of other drugs

Note: The adult ADHD segment is growing but remains dominated by stimulants, leaving pediatric non-stimulant options like INTUNIV primarily in the pediatric segment.

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Market Dynamics Influencing INTUNIV

Clinical Positioning and Prescribing Trends

• Non-Stimulant Preference: Growing concerns about stimulant misuse and side effects prompt a rising preference for non-stimulant therapies like INTUNIV.
• Efficacy and Safety: Clinical trials demonstrate INTUNIV’s efficacy in reducing ADHD symptoms with a favorable safety profile, especially in patients unresponsive to stimulants.
• Guideline Recommendations: The American Academy of Pediatrics (AAP) and the American Psychiatric Association endorse non-stimulants as second-line or alternative treatments, supporting sustained demand.

Regulatory Landscape

• Patent Expiry and Generics: The primary patent for INTUNIV expired in 2024 in the United States, opening the door for generic competitors.
• Approval of Generics: Since patent expiry, multiple generic formulations have entered the market, exerting downward pressure on prices.
• Pricing Policies: Payer reimbursement dynamics, prior authorization hurdles, and formulary placements influence prescribing patterns.

Market Penetration and Adoption

• Pediatric Focus: Approximately 80-85% of prescriptions originate from pediatric neurologists and psychiatrists.
• Regional Variations: U.S. remains the core market, with emerging markets in Europe and Asia showing increasing adoption as awareness and diagnostic pathways improve.

Supply Chain and Manufacturing

• Manufacturing Capacity: Takeda has enhanced manufacturing capabilities post-2015 to accommodate demand, with capacity expansions aligned with sales growth.
• Supply Challenges: Slight disruptions during the COVID-19 pandemic affected distribution, but stability has since improved.

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Financial Trajectory Forecasts

Historical Sales Performance (2018-2022)

Year	Estimated Sales (USD millions)	YoY Growth	Market Share
2018	280	—	6.8% in ADHD non-stimulant segment
2019	450	+60.7%	8.4%
2020	620	+37.8%	8.5%
2021	720	+16.1%	8.2%
2022	750	+4.2%	8.4%

Note: Figures are estimates based on industry reports and Takeda disclosures.

Projected Sales (2023-2027)

Year	Estimated Sales (USD millions)	Assumptions
2023	820	Post-generic entry stabilization phase
2024	920	Full generic market penetration begins
2025	650	Continued price erosion, volume stabilization
2026	700	Market adaptation and growth in emerging regions
2027	750	Market maturity, slight growth

Key Drivers of Sales

• Patent Cliff Impact: Significant price erosion expected post-2024 as generics dominate.
• Market Expansion: Entry into new regional markets (Europe, Asia) can offset U.S. market decline.
• Formulation Innovation: Development of combo pills and new delivery methods could stimulate demand.
• Competitor Dynamics: Entrants like other non-stimulants (e.g., clonidine ER, centanafadine) influence market share.

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Competitive Landscape

Drug	Mechanism	Indication	Market Share (2022)	Strengths	Weaknesses
INTUNIV	Guanfacine ER	ADHD (Pediatric)	~8.4%	Favorable safety profile, long-acting	Patent expiry, generic entry
Kapvay	Clonidine ER	ADHD (Pediatric)	N/A	Similar efficacy, familiar agent	Side effect profile, less first-line preference
Strattera (Atomoxetine)	Selective NRI	ADHD	N/A	Non-stimulant, evidence-based	Less efficacy, delayed onset
Vyvanse	Amphetamine prodrug	ADHD	Major stimulant	High efficacy, abuse deterrent	Stimulant-related concerns

Note: Market share figures are approximate, derived from IQVIA data and industry surveys.

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Regulatory and Policy Considerations

Factor	Implication
Patent expiration	Increased generic competition from 2024 onward
Pricing and Reimbursement	Payers scrutinize costs, favor generics, implement prior authorizations
Off-label prescribing	May influence demand in certain age groups or indications
Global approvals	Opportunities in Europe (EMA approval since 2011), emerging markets

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Comparison with Alternatives

Parameter	INTUNIV	Stimulants	Other Non-Stimulants
Efficacy	Moderate to high	High	Variable
Side Effects	Dizziness, fatigue, sedation	Insomnia, appetite suppression	Dry mouth, sedation
Abuse Potential	Low	High	Low
Onset of Action	1-2 weeks	Immediate	1-2 weeks
Cost	Moderate (post-patent expiry)	Variable (higher for branded)	Lower (generics)

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Deep Dive: Patent and Market Entry Timelines

Year	Event	Implication
2010	FDA approval of INTUNIV	Market launch
2014	Patent expiration filing	Anticipated expiration (expected 2024)
2024	Patent expiry, generic entry begins	Price erosion and increased volume
2025-2027	Market consolidation, brand vs. generic dynamics	Establishment of market equilibrium

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Key Market and Financial Risks

Risk Factor	Potential Impact
Patent cliff	Revenue erosion post-2024
Generic price war	Margins compressed, volume-driven revenue strategy
Regulatory delays or policy changes	Could delay approvals in new markets
Competition from newer agents	Market share reduction if superior agents emerge
Supply chain disruptions	Short-term sales impact, particularly post-pandemic

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Key Takeaways

• Pre-Patent Expiry Phase: INTUNIV benefitted from a growing pediatric ADHD market, commanding a significant share due to its safety profile and clinical advantages.
• Patent Cliff: The imminent patent expiry in 2024 will introduce multiple generics, leading to price erosion and potentially halving peak revenues.
• Post-2024 Outlook: The brand's revenue is projected to decline; however, expansion into new geographies and formulation innovation could mitigate some impacts.
• Pricing Strategies: Takeda may adopt value-based pricing and patient assistance programs to preserve market share amid generic competition.
• Market Expansion: Opportunities in emerging markets, where ADHD diagnosis is rising, could stabilize revenue streams.

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FAQs

1. How significantly will patent expiration impact INTUNIV’s sales?
Patent expiration in 2024 is expected to cause substantial price erosion as generics enter, potentially reducing brand sales by 50-70%. Despite volume increases, revenue likely declines unless offset by new markets or formulations.

2. Are there any newer non-stimulant agents threatening INTUNIV's market?
Yes. Agents like centanafadine (currently in late-stage trials) and viloxazine ER (approved for ADHD) are emerging, offering alternative mechanisms and potentially capturing market share post-INTUNIV patent expiry.

3. Which markets outside the U.S. are most promising for INTUNIV?
Europe (EMA approval since 2011), parts of Asia (Japan, South Korea), and Latin America present growth opportunities due to rising ADHD awareness and limited existing non-stimulant options.

4. How does INTUNIV’s safety profile influence its market prospects?
Its favorable safety and tolerability profile, especially regarding lower abuse potential compared to stimulants, positions INTUNIV as a preferred alternative in specific pediatric cases, supporting sustained demand.

5. What strategic moves can Takeda pursue to maximize INTUNIV’s future revenues?
Focusing on formulation innovations, expanding generics licensing agreements, entering new markets early, and developing adjacent formulations (e.g., combination pills) can help offset revenue declines.

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References

1. IQVIA. (2022). Global ADHD Market Analysis.
2. Takeda Pharmaceuticals. (2022). INTUNIV Clinical Data and Market Reports.
3. U.S. Food and Drug Administration. (2010–2022). Drug Approvals and Patent Information.
4. American Academy of Pediatrics. (2019). Guidelines for ADHD Management.
5. EvaluatePharma. (2022). Top 100 Pharma & Biotech Products: Sales & Forecasts.