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:	1,315
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	5,854,290*PED
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	6,811,794*PED
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	5,854,290*PED
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	6,287,599*PED
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	6,811,794*PED
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	6,811,794*PED
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	5,854,290*PED

International Patents for INTUNIV

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

Country	Patent Number	Title	Estimated Expiration
Canada	2432178	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)
Israel	129460
Denmark	1351668
Japan	2001504811
Spain	2527854
Portugal	1351668
Australia	6281298

Market Dynamics and Financial Trajectory for INTUNIV (Guanfacine Extended-Release)

Last updated: November 20, 2025

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Introduction

INTUNIV (generic: Guanfacine Extended-Release) stands as a significant player within the pediatric and adult neuropsychiatric therapeutics landscape, primarily indicated for Attention Deficit Hyperactivity Disorder (ADHD). As an extended-release formulation of guanfacine, it capitalizes on a growing demand for non-stimulant ADHD treatments. Understanding the current market dynamics and forecasted financial trajectory of INTUNIV involves assessing regulatory developments, competitive positioning, market size, and broader health policy shifts influencing its adoption.

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Market Overview

The global ADHD therapeutics market has experienced robust growth, driven by increasing diagnosis rates, evolving treatment guidelines, and patient preference shifts away from stimulant medications due to abuse potential. According to MarketsandMarkets, the ADHD drugs market size was valued at approximately USD 14 billion in 2022 and is projected to reach USD 22 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of around 6%. This upward trajectory benefits non-stimulant medications like INTUNIV, especially amidst concerns about stimulant misuse and adverse effects.

INTUNIV, branded by Takeda Pharmaceuticals, holds a critical niche as a non-stimulant first-line option and adjunct therapy, especially in patients with contraindications for stimulants or who experience significant side effects from stimulant treatments.

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Market Dynamics

1. Regulatory Environment and Approvals

The regulatory landscape directly influences INTUNIV’s market access. The FDA approved INTUNIV for pediatric patients aged 6–17 in 2010, with subsequent approvals extending indications. Recently, regulatory agencies globally continue to pursue approval of non-stimulant agents, broadening potential markets. For instance, Japan approved guanfacine for ADHD in children over six in 2015, and similar regulatory pathways are pursuing approval across Europe. The timing and scope of these approvals influence market penetration and revenue potential.

2. Competitive Positioning

INTUNIV competes primarily with stimulant medications like methylphenidate and amphetamines, which dominate the ADHD treatment paradigm. However, non-stimulant options such as STRATTERA (atomoxetine), clonidine extended-release, and newer agents like viloxazine are gaining prominence. Guanfacine's unique mechanism of action—selective alpha-2A adrenergic receptor agonism—offers benefits for specific patient subsets, including those with comorbid tics or anxiety, allowing for niche expansion.

3. Prescriber and Patient Preferences

Growing awareness of stimulant side effects, including sleep disturbances, appetite suppression, and abuse liability, shifts prescriber preference towards non-stimulants like INTUNIV. Additionally, the pediatric population’s cautious approach to stimulant medications enhances demand for alternatives. Ongoing education campaigns highlighting safety profiles bolster this trend.

4. Pricing and Reimbursement Policies

Pricing strategies for INTUNIV vary globally, influencing revenue. In the U.S., Medicare and Medicaid reimbursement policies can impact accessibility, especially for pediatric patients. Patent protections and potential formulations or delivery system improvements can stymie generic competition and sustain premium pricing.

5. Patent Landscape and Generic Competition

Guanfacine is off-patent, with multiple generic versions available, reducing price point and market share for branded INTUNIV. Nonetheless, branded formulations often command higher margins due to perceived quality differences, packaging, or formulation-specific advantages.

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Financial Trajectory

1. Historical Revenue Performance

Since its launch, INTUNIV has demonstrated steady growth. Takeda reported US sales of approximately USD 775 million for INTUNIV in fiscal year 2022, representing a significant portion of its pediatric neuropsychiatric portfolio. While facing generic erosion, branded sales remain resilient because of brand loyalty, formulary preferences, and indications for specific patient subsets.

2. Revenue Drivers

The primary revenue drivers include:

• Expanding indications: Trials investigating INTUNIV for adult ADHD and other neuropsychiatric conditions, such as tic disorders, could broaden market potential.
• Geographic expansion: Entering emerging markets remains a strategic focus, where ADHD diagnosis and treatment are rising.
• Formulation innovations: Improved formulations offering better adherence or reduced side effects can bolster sales.

3. Future Growth Projections

Despite patent expiry and generics saturating the market, revenue is projected to maintain moderate growth through:

• Increased diagnosis rates and treatment initiation.
• Growing acceptance of non-stimulants.
• Potential new indications or combination therapies.

Industry analysts project a compound annual growth rate (CAGR) of approximately 2-4% for INTUNIV’s global sales over the next five years, with notable variability based on market penetration and competitive pressures.

4. Impact of Market Penetration Strategies

Takeda’s focus on formulary placement and clinician education remains critical. Additionally, partnering with payers to improve access and reimbursement can sustain revenue streams. Any strategic acquisition of local distributors or licensing agreements in emerging markets could catalyze additional growth.

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Factors Influencing Financial Outlook

• Market Competition: The intensification of competition from both branded and generic non-stimulant therapies poses a threat to market share.
• Regulatory Approvals: Approval of INTUNIV for broader indications, particularly in adult populations, could dramatically alter revenue streams.
• Pricing Pressures: Heightened healthcare cost containment strategies may compress margins.
• Research & Development: Invested R&D in novel delivery systems or combination products can unlock new revenue avenues.
• Health Policy Dynamics: Growing emphasis on personalized medicine and mental health initiatives support continued demand, especially where non-stimulants are favored.

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Emerging Trends and Opportunities

1. Digital Health Integration

Integration of digital adherence tools, telehealth, and remote monitoring could improve treatment compliance for INTUNIV, expanding its patient base and facilitating post-market surveillance.

2. Focus on Comorbidities

Identification of comorbid conditions, such as oppositional defiant disorder or tics, which respond favorably to guanfacine, can widen its application, driving sales beyond the traditional pediatric ADHD segment.

3. Market Expansion and Policy Support

Government policies aimed at curbing stimulant misuse and promoting safe pharmacotherapy options underpin a favorable environment for non-stimulant drugs, including INTUNIV.

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Key Takeaways

• INTUNIV operates within a competitive, expanding ADHD treatment market, driven by increasing diagnosis rates and a shift toward non-stimulant therapies.
• Patent expiries and generic competition threaten branded sales; however, brand loyalty, indications for specific subpopulations, and formulary positioning support continued revenue.
• Revenue growth is expected to be modest (~2-4% CAGR), bolstered by geographic expansion, new indications, and innovation.
• Future opportunities lie in leveraging digital health tools, establishing new clinical uses, and expanding into emerging markets bolstered by health policy shifts favoring non-stimulant treatments.
• Strategic collaborations and research into formulation improvements will further modulate the financial trajectory.

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FAQs

Q1: What are the primary competitors of INTUNIV in the ADHD market?
A1: The main competitors include stimulant medications like methylphenidate and amphetamines, as well as other non-stimulants like atomoxetine (STRATTERA) and clonidine extended-release formulations.

Q2: How does patent expiration influence the financial outlook for INTUNIV?
A2: Patent expiry leads to increased generic competition, which typically reduces prices and branded market share. However, brand loyalty and niche indications can sustain revenue levels.

Q3: Are there upcoming regulatory changes that could impact INTUNIV?
A3: Yes. Regulatory approvals for broader age ranges, new indications, or formulations could open new markets, positively affecting financials.

Q4: What role does health policy play in shaping INTUNIV’s market?
A4: Policies promoting safe medication use and restricting stimulant misuse favor non-stimulant drugs like INTUNIV. Reimbursement and formulary decisions also significantly influence sales.

Q5: What growth opportunities exist outside the United States?
A5: Emerging markets with rising ADHD diagnosis and increased healthcare infrastructure present significant growth potential, especially if regulatory approvals are secured and local partnerships are established.

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Sources

1. MarketsandMarkets. ADHD Drugs Market Size and Forecast, 2022-2030.
2. Takeda Pharmaceuticals Annual Reports, FY2022.
3. U.S. Food and Drug Administration (FDA) Official Website.
4. GlobalData, Pharmaceutical Market Analytics.
5. World Health Organization (WHO). Global ADHD Treatment Guidelines.